Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007283751

FEI Number

3007283751

Entity Name

CAMLOG Biotechnologies GmbH

City/State/Country

Basel Basel-Stadt, CH

Establishment Address

Grosspeteranlage 29, Basel Basel-Stadt 4052, CH

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device,Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

CAMLOG Biotechnologies GmbH (Owner Number: 9071675)

Owner / Operator Contact Address

Grosspeteranlage 29, Basel, CH-BS 4052, CH

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K193401

PMA Number

N/A

All Registered Proprietary Names

J5015.4300 Depth stop for form drills SCREW-LINE, with reduced coil d 4.3 mm J5050.2300 Round bur, d 2.3 mm J5054.3809 Tap SCREW-LINE d 3.8 mm J5062.3811 Form drill SCREW-LINE d 3.8 mm, L 11 mm J5066.4316 Guide Form drill, SL, internal irrigation d 4.3 mm L 16 mm d 4.3 L 16 J5068.4316 Guide Form drill, SL, cortical bone d 4.3 mm L 16 mm d 4.3 L 16 J5072.4300 Dense bone drill PROGRESSIVE-LINE, d 4.3 mm J5078.3809 Guide dense bone drill, PL, d 3.8 mm, L 9 mm J3713.3300 Guide Template drill J5015.5000 Depth stop for form drills SCREW-LINE d 5 mm J5050.3500 Round bur, d 3.5 mm J5054.3809 Tap SCREW-LINE, with hexagon, d 3.8 mm J5062.3813 Form drill SCREW-LINE d 3.8 mm, L 13 mm J5070.3309 Form drill PROGRESSIVE-LINE, d 3.3 mm, L 9 J5072.4302 Dense bone drill 2 PROGRESSIVE-LINE, d 4.3 mm J5078.3811 Guide dense bone drill, PL, d 3.8 mm, L 11 mm J5015007 Depth stop, SCREW-LINE, f. pilot drill and pre-drill L 7 mm J5015.5000 Depth stop for form drills SCREW-LINE, with reduced coil d 5 mm J5065.3311 Guide Surgery set, SL, internal irrigation d 3.3 mm L 11 mm d 3.3 L 11 J5068.3311 Guide Form drill, SL, cortical bone d 3.3 mm L 11 mm d 3.3 L 11 J5076.3807 Guide Form drill, PL, d 3.8 mm, L 7 mm J5076.5011 Guide Form drill, PL, d 5 mm, L 11 mm J5081.3316 Guide dense bone drill 2 PL, d 3.3 mm, L 16 mm J5081.5013 Guide dense bone drill 2 PL, d 5 mm, L 13 mm J5004.3300 Baring drill for cover screw, for d 3.3 mm J5015013 Depth stop SCREW-LINE for pilot drill (J5051.2000) and pre-drill (J5051.2800) L 13 mm J5063.3311 Guide Pilot drill set, d 2 mm, internal irrigation d 3.3 mm L 11 mm d 3.3 L 9 J5065.3813 Guide Surgery set, SL, internal irrigation d 3.8 mm L 13 mm d 3.8 L 13 J5074.5011 Guide Pilot drill, PL, d 2 mm, d 5 mm, L 11 mm J5076.4305 Guide Pre-drill, PL, d 4.3 mm, L 5 mm P5054.4401 iSy® Tap for d 4.4 J5015.4300 Depth stop for form drills SCREW-LINE d 4.3 mm J5041.5004 Guide Gingiva punch, PL, d 5 mm J5054.3309 Tap SCREW-LINE, with hexagon, d 3.3 mm J5066.3816 Guide Form drill, SL, internal irrigation d 3.8 mm L 16 mm d 3.8 L 16 J5068.4313 Guide Form drill, SL, cortical bone d 4.3 mm L 13 mm d 4.3 L 13 J5072.3802 Dense bone drill 2 PROGRESSIVE-LINE, d 3.8 mm J5076.5005 Guide Pre-drill, PL, d 5 mm, L 5 mm J5078.3807 Guide dense bone drill, PL, d 3.8 mm, L 7 mm J5003.3350 Bone profiler d= 5 for d= 3.3 mm, stainless steel J5062.6013 Form drill SCREW-LINE d 6 mm, L 13 mm J5070.5007 Form drill PROGRESSIVE-LINE, d 5 mm, L 7 J5074.5005 Guide Pilot drill, PL, d 2 mm, d 5 mm, L 5 mm J5076.3811 Guide Form drill, PL, d 3.8 mm, L 11 mm J5079.3800 Drill PROGRESSIVE-LINE Flex, d 3.8 mm P5040.5001 iSy® Single patient form drill d 5 (3 piece) J5015.3300 Depth stop for form drills SCREW-LINE, with reduced coil d 3.3 mm J5053.5016 Form drill SCREW-LINE, Cortical bone d 5 mm J5065.4311 Guide Surgery set, SL, internal irrigation d 4.3 mm L 11 mm d 4.3 L 11 J5076.4311 Guide Form drill, PL, d 4.3 mm, L 11 mm J5078.3311 Guide dense bone drill, PL, d 3.3 mm, L 11 mm H5300070 Surgery set CERALOG® PROGRESSIVE-LINE Flex J5004.4300 Baring drill for cover screw, for d 4.3 mm J5015.3300 Depth stop for form drills SCREW-LINE d 3.3 mm J5053.4316 Form drill SCREW-LINE, Cortical bone d 4.3 mm J5065.4309 Guide Surgery set, SL, internal irrigation d 4.3 mm L 9 mm d 4.3 L 9 J5076.4309 Guide Form drill, PL, d 4.3 mm, L 9 mm P5330100 iSy® Surgery and prosthetic set J3713.4300 Guide Template drill J5051.2000 Pilot drill SCREW-LINE, reduced coil d 2 mm J5054.4309 Tap SCREW-LINE, with hexagon, d 4.3 mm J5062.4307 Form drill SCREW-LINE d 4.3 mm, L 7 mm J5070.3313 Form drill PROGRESSIVE-LINE, d 3.3 mm, L 13 J5070.5011 Form drill PROGRESSIVE-LINE, d 5 mm, L 11 J5072.5002 Dense bone drill 2 PROGRESSIVE-LINE, d 5 mm J5078.3816 Guide dense bone drill, PL, d 3.8 mm, L 16 mm J5079.5000 Drill PROGRESSIVE-LINE Flex, d 5 mm J5036820 Spiral drill, reverse action d 0.82 mm, J5054.6009 Tap SCREW-LINE d 6 mm J5068.3809 Guide Form drill, SL, cortical bone d 3.8 mm L 9 mm d 3.3 L 9 J5077.3311 Guide Form drill for d 3.8 mm under preparation, PL, d 3.3 mm, L 11 mm J5078.4311 Guide dense bone drill, PL, d 4.3 mm, L 11 mm J5081.3813 Guide dense bone drill 2 PL, d 3.8 mm, L 13 mm J3733.3300 Guide Template drill d 3.3 mm J5004.5000 Baring drill for cover screw, for d 5 mm J5053.3316 Form drill SCREW-LINE, Cortical bone d 3.3 mm J5062.4316 Form drill SCREW-LINE d 4.3 mm, L 16 mm J5063.4309 Guide Pilot drill set, d 2 mm, internal irrigation d 3.8/4.3 mm L 9 mm d 3.8/4.3 L 9 J5071.3800 Tap PROGRESSIVE-LINE, d 3.8 mm J5074.3313 Guide Pilot drill, PL, d 2 mm, d 3.3 mm, L 13 mm J5076.3305 Guide Pre-drill, PL, d 3.3 mm, L 5 mm J5080.5000 Profile drill PROGRESSIVE-LINE Flex, d 5 mm J5081.4311 Guide dense bone drill 2 PL, d 4.3 mm, L 11 mm J5041.3304 Guide Gingiva punch, PL, d 3.3 mm J5062.3309 Form drill SCREW-LINE d 3.3 mm, L 9 mm J5068.3813 Guide Form drill, SL, cortical bone d 3.8 mm L 13 mm d 3.3 L 13 J5070.3813 Form drill PROGRESSIVE-LINE, d 3.8 mm, L 13 J5077.3316 Guide Form drill for d 3.8 mm under preparation, PL, d 3.3 mm, L 16 mm J5078.4316 Guide dense bone drill, PL d 4.3 mm, L 16 mm J3713.3300 Guide Template drill d 3.3 mm J5051.1500 Point drill, d 1.5 mm J5054.4309 Tap SCREW-LINE d 4.3 mm J5062.3816 Form drill SCREW-LINE d 3.8 mm, L 16 mm J5070.3311 Form drill PROGRESSIVE-LINE, d 3.3 mm, L 11 J5072.5000 Dense bone drill PROGRESSIVE-LINE, d 5 mm J5078.3813 Guide dense bone drill, PL, d 3.8 mm, L 13 mm J5079.4300 Drill PROGRESSIVE-LINE Flex, d 4.3 mm J3713.5555 Template drill Camlog Guide J5051.2003 Pilot drill without coil d 2 mm J5062.4311 Form drill SCREW-LINE d 4.3 mm, L 11 mm J5070.3807 Form drill PROGRESSIVE-LINE, d 3.8 mm, L 7 J5070.5016 Form drill PROGRESSIVE-LINE, d 5 mm, L 16 J5074.3309 Guide Pilot drill, PL, d 2 mm, d 3.3 mm, L 9 mm J5074.5013 Guide Pilot drill, PL, d 2 mm, d 5 mm, L 13 mm J5078.4309 Guide dense bone drill, PL, d 4.3 mm, L 9 mm J5080.3800 Profile drill PROGRESSIVE-LINE Flex, d 3.8 mm J5081.4307 Guide dense bone drill 2 PL, d 4.3 mm, L 7 mm J5015.3800 Depth stop for form drills SCREW-LINE, with reduced coil d 3.8 mm J5041.4304 Guide Gingiva punch, PL, d 4.3 mm J5054.3309 Tap SCREW-LINE d 3.3 mm J5066.3316 Guide Form drill, SL, internal irrigation d 3.3 mm L 16 mm d 3.3 L 16 J5068.4311 Guide Form drill, SL, cortical bone d 4.3 mm L 11 mm d 4.3 L 11 J5076.4316 Guide Form drill, PL, d 4.3 mm, L 16 mm J5078.3316 Guide dense bone drill, PL, d 3.3 mm, L 16 mm J5003.5070 Bone profiler d= 7 for d= 5 mm, stainless steel J5015011 Depth stop SCREW-LINE, f. pilot drills and pre-drills L 11 mm J5063.3309 Guide Pilot drill set, d 2 mm, internal irrigation d 3.3 mm L 9 mm d 3.3 L 9 J5065.3811 Guide Surgery set, SL, internal irrigation d 3.8 mm L 11 mm d 3.8 L 11 J5074.5009 Guide Pilot drill, PL, d 2 mm, d 5 mm, L 9 mm J5076.3816 Guide Form drill, PL, d 3.8 mm, L 16 mm P5054.3801 iSy® Tap for d 3.8 J5015009 Depth stop SCREW-LINE for pilot drill (J5051.2000) and pre-drill (J5051.2800) L 9 mm J5015.6000 Depth stop for form drills SCREW-LINE d 6 mm J5065.3313 Guide Surgery set, SL, internal irrigation d 3.3 mm L 13 mm d 3.3 L 13 J5068.3313 Guide Form drill, SL, cortical bone d 3.3 mm L 13 mm d 3.3 L 13 J5076.3809 Guide Form drill, PL, d 3.8 mm, L 9 mm J5076.5013 Guide Form drill, PL, d 5 mm, L 13 mm J5081.3807 Guide dense bone drill 2 PL, d 3.8 mm, L 7 mm J3733.4300 Guide Template drill J5006.3346 Countersink d 4.6, for d 3.3 mm J5062.5007 Form drill SCREW-LINE d 5 mm, L 7 mm J5063.4311 Guide Pilot drill set, d 2 mm, internal irrigation d 3.8/4.3 mm L 11 mm d 3.8/4.3 L 11 J5071.4300 Tap PROGRESSIVE-LINE, d 4.3 mm J5074.3316 Guide Pilot drill, PL, d 2 mm, d 3.3 mm, L 16 mm J5076.3309 Guide Form drill, PL, d 3.3 mm, L 9 mm J5300061 Surgery set SCREW-LINE J5300075 Surgery-set PROGRES-SIVE-LINE J5081.4313 Guide dense bone drill 2 PL, d 4.3 mm, L 13 mm J3733.4300 Guide Template drill d 3.8/4.3 mm J5006.3852 Countersink d 5.2, for d 3.8 mm J5062.5009 Form drill SCREW-LINE d 5 mm, L 9 mm J5063.4313 Guide Pilot drill set, d 2 mm, internal irrigation d 3.8/4.3 mm L 13 mm d 3.8/4.3 L 13 J5071.5000 Tap PROGRESSIVE-LINE, d 5 mm J5076.3311 Guide Form drill, PL, d 3.3 mm, L 11 mm J5300063 Surgery Set SCREW-LINE J5300081 Surgery-set PROGRES-SIVE-LINE Flex J5081.4316 Guide dense bone drill 2 PL, d 4.3 mm, L 16 mm J5015009 Depth stop SCREW-LINE, f. pilot drills and pre-drills L 9 mm J5015.6000 Depth stop for form drills SCREW-LINE, with reduced coil d 6 mm J5054.5009 Tap SCREW-LIN d 5 mm J5065.3807 Guide Surgery set, SL, internal irrigation d 3.8 mm L 7 mm d 3.8 L 7 J5068.3316 Guide Form drill, SL, cortical bone d 3.3 mm L 16 mm d 3.3 L 16 J5076.5016 Guide Form drill, PL, d 5 mm, L 16 mm J5081.3809 Guide dense bone drill 2 PL, d 3.8 mm, L 9 mm J5015011 Depth stop SCREW-LINE for pilot drill (J5051.2000) and pre-drill (J5051.2800) L 11 mm J5036820 Spiral drill reverse action for CAMLOG® and CONELOG® Re-Set, d 0.82 mm, J5054.5009 Tap SCREW-LINE, with hexagon, d 5 mm J5068.3807 Guide Form drill, SL, cortical bone d 3.8 mm L 7 mm d 3.3 L 7 J5077.3309 Guide Form drill for d 3.8 mm under preparation, PL, d 3.3 mm, L 9 mm J5081.3811 Guide dense bone drill 2 PL, d 3.8 mm, L 11 mm J3753.3300 Guide Template drill, PL, d 3.3 mm J5006.4356 Countersink d 5.6, for d 4.3 mm J5064.3316 Guide Pilot drill, d 2 mm, internal irrigation d 3.3 mm L 16 mm d 3.3 L 16 J5072.3300 Dense bone drill PROGRESSIVE-LINE, d 3.3 mm J5076.3313 Guide Form drill, PL, d 3.3 mm, L 13 mm J5300065 Surgery-Set PROGRESSIVE-LINE J5081.3309 Guide dense bone drill 2 PL, d 3.3 mm, L 9 mm J5081.5007 Guide dense bone drill 2 PL, d 5 mm, L 7 mm J5015.3800 Depth stop for form drills SCREW-LINE d 3.8 mm J5053.6016 Form drill SCREW-LINE, Cortical bone d 6 mm J5065.4313 Guide Surgery set, SL, internal irrigation d 4.3 mm L 13 mm d 4.3 L 13 J5068.4309 Guide Form drill, SL, cortical bone d 4.3 mm L 9 mm d 4.3 L 9 J5076.4313 Guide Form drill, PL, d 4.3 mm, L 13 mm J5078.3313 Guide dense bone drill, PL, d 3.3 mm, L 13 mm J5004.3800 Baring drill for cover screw, for d 3.8 mm J5015013 Depth stop SCREW-LINE, f. pilot drills and pre-drills L 13 mm J5053.3816 Form drill SCREW-LINE, Cortical bone d 3.8 mm J5063.3313 Guide Pilot drill set, d 2 mm, internal irrigation d 3.3 mm L 13 mm d 3.3 L 13 J5065.4307 Guide Surgery set, SL, internal irrigation d 4.3 mm L 7 mm d 4.3 L 7 J5076.4307 Guide Form drill, PL, d 4.3 mm, L 7 mm P5054.5001 iSy® Tap for d 5 A2050.2600 Drill for CT-tube (for A2002.2000), d 2.6 mm J5041.3803 Guide Gingiva punch d 3.8 mm J5062.3311 Form drill SCREW-LINE d 3.3 mm, L 11 mm J5068.3816 Guide Form drill, SL, cortical bone d 3.8 mm L 16 mm d 3.3 L 16 J5070.3816 Form drill PROGRESSIVE-LINE, d 3.8 mm, L 16 J5074.4305 Guide Pilot drill, PL, d 2 mm, d 3.8/4.3 mm, L 5 mm J5078.3309 Guide dense bone drill, PL, d 3.3 mm, L 9 mm J5078.5007 Guide dense bone drill, PL, d 5 mm, L 7 mm J5003.4360 Bone profiler d= 6 for d= 3.8 and 4.3 mm, stainless steel J5062.6016 Form drill SCREW-LINE d 6 mm, L 16 mm J5065.3809 Guide Surgery set, SL, internal irrigation d 3.8 mm L 9 mm d 3.8 L 9 J5070.5009 Form drill PROGRESSIVE-LINE, d 5 mm, L 9 J5074.5007 Guide Pilot drill, PL, d 2 mm, d 5 mm, L 7 mm J5076.3813 Guide Form drill, PL, d 3.8 mm, L 13 mm P5051.2202 iSy® Pilot drill J5015007 Depth stop SCREW-LINE for pilot drill (J5051.2000) and pre-drill (J5051.2800) L 7 mm J5065.3309 Guide Surgery set, SL, internal irrigation d 3.3 mm L 9 mm d 3.3 L 9 J5068.3309 Guide Form drill, SL, cortical bone d 3.3 mm L 9 mm d 3.3 L 9 J5072.3800 Dense bone drill PROGRESSIVE-LINE, d 3.8 mm J5076.3805 Guide Pre-drill, PL, d 3.8 mm, L 5 mm J5076.5009 Guide Form drill, PL, d 5 mm, L 9 mm J5081.3313 Guide dense bone drill 2 PL, d 3.3 mm, L 13 mm J5081.5011 Guide dense bone drill 2 PL, d 5 mm, L 11 mm J5006.5063 Countersink d 6.3, for d 5 mm J5064.4316 Guide Pilot drill, d 2 mm, internal irrigation d 3.8/4.3 mm L 16 mm d 3.8/4.3 L 16 J5072.3302 Dense bone drill 2 PROGRESSIVE-LINE, d 3.3 mm J5076.3316 Guide Form drill, PL, d 3.3 mm, L 16 mm J5076.5007 Guide Form drill, PL, d 5 mm, L 7 mm J5300071 Surgery-Set PROGRESSIVE-LINE Flex J5081.3311 Guide dense bone drill 2 PL, d 3.3 mm, L 11 mm J5081.5009 Guide dense bone drill 2 PL, d 5 mm, L 9 mm J3733.3300 Guide Template drill J5051.2800 Pre-drill SCREW-LINE d 1.7-2.8 mm J5062.4313 Form drill SCREW-LINE d 4.3 mm, L 13 mm J5063.4307 Guide Pilot drill set, d 2 mm, internal irrigation d 3.8/4.3 mm L 7 mm d 3.8/4.3 L 7 J5070.3809 Form drill PROGRESSIVE-LINE, d 3.8 mm, L 9 J5071.3300 Tap PROGRESSIVE-LINE, d 3.3 mm J5074.3311 Guide Pilot drill, PL, d 2 mm, d 3.3 mm, L 11 mm J5074.5016 Guide Pilot drill, PL, d 2 mm, d 5 mm, L 16 mm J5080.4300 Profile drill PROGRESSIVE-LINE Flex, d 4.3 mm J5081.4309 Guide dense bone drill 2 PL, d 4.3 mm, L 9 mm A2050.2800 Drill for CT-tube (for A2222.2200), d 2.8 mm J3753.5000 Guide Template drill d 5 mm J5062.3807 Form drill SCREW-LINE d 3.8 mm, L 7 mm A2050.2800 Template drill for placement of CT-tubes d 2.8 mm J5062.5016 Form drill SCREW-LINE d 5 mm, L 16 mm J5070.4311 Form drill PROGRESSIVE-LINE, d 4.3 mm, L 11 J5002005 Drill extension, ISO shaft J5062.6011 Form drill SCREW-LINE d 6 mm, L 11 mm J5074.4311 Guide Pilot drill, PL, d 2 mm, d 3.8/4.3 mm, L 11 mm J5070.4316 Form drill PROGRESSIVE-LINE, d 4.3 mm, L 16 J5078.5013 Guide dense bone drill, PL, d 5 mm, L 13 mm J5300074 Guide System Starter Set PROGRESSIVE-LINE J5074.4316 Guide Pilot drill, PL, d 2 mm, d 3.8/4.3 mm, L 16 mm J5079.3300 Drill PROGRESSIVE-LINE Flex, d 3.3 mm P5040.4401 iSy® Single patient form drill d 4.4 (3 piece) J5081.5016 Guide dense bone drill 2 PL, d 5 mm, L 16 mm J3713.4300 Guide Template drill d 3.8/4.3 mm J5051.2000 Pilot drill, reduced coil d 2 mm J5062.4309 Form drill SCREW-LINE d 4.3 mm, L 9 mm J5070.3316 Form drill PROGRESSIVE-LINE, d 3.3 mm, L 16 J5070.5013 Form drill PROGRESSIVE-LINE, d 5 mm, L 13 J5074.3305 Guide Pilot drill, PL, d 2 mm, d 3.3 mm, L 5 mm J5078.4307 Guide dense bone drill, PL, d 4.3 mm, L 7 mm J5080.3300 Profile drill PROGRESSIVE-LINE Flex, d 3.3 mm J5081.3816 Guide dense bone drill 2 PL, d 3.8 mm, L 16 mm A2050.2600 Template drill for placement of CT-tubes J5041.3804 Guide Gingiva punch, PL, d 3.8 mm J5062.3313 Form drill SCREW-LINE d 3.3 mm, L 13 mm J5062.5011 Form drill SCREW-LINE d 5 mm, L 11 mm J5068.4307 Guide Form drill, SL, cortical bone d 4.3 mm L 7 mm d 4.3 L 7 J5070.4307 Form drill PROGRESSIVE-LINE, d 4.3 mm, L 7 J5074.4307 Guide Pilot drill, PL, d 2 mm, d 3.8/4.3 mm, L 7 mm J5078.5009 Guide dense bone drill, PL, d 5 mm, L 9 mm A2050.2600 Template drill for placement of CT-tubes d 2.6 mm J3753.4300 Guide Template drill, PL, d 3.8/4.3 mm J5041.4303 Guide Gingiva punch d 4.3 mm J5062.3316 Form drill SCREW-LINE d 3.3 mm, L 16 mm J5062.5013 Form drill SCREW-LINE d 5 mm, L 13 mm J5070.4309 Form drill PROGRESSIVE-LINE, d 4.3 mm, L 9 J5074.4309 Guide Pilot drill, PL, d 2 mm, d 3.8/4.3 mm, L 9 mm J5078.5011 Guide dense bone drill, PL, d 5 mm, L 11 mm J5041.3303 Guide Gingiva punch d 3.3 mm J5054.6009 Tap SCREW-LINE, with hexagon, d 6 mm J5068.3811 Guide Form drill, SL, cortical bone d 3.8 mm L 11 mm d 3.3 L 11 J5070.3811 Form drill PROGRESSIVE-LINE, d 3.8 mm, L 11 J5077.3313 Guide Form drill for d 3.8 mm under preparation, PL, d 3.3 mm, L 13 mm J5078.4313 Guide dense bone drill, PL, d 4.3 mm, L 13 mm A2050.2800 Template drill for placement of CT-tubes J5002005 Drill extension J5062.3809 Form drill SCREW-LINE d 3.8 mm, L 9 mm J5062.6009 Form drill SCREW-LINE d 6 mm, L 9 mm J5070.4313 Form drill PROGRESSIVE-LINE, d 4.3 mm, L 13 J5074.4313 Guide Pilot drill, PL, d 2 mm, d 3.8/4.3 mm, L 13 mm J5078.5016 Guide dense bone drill, PL, d 5 mm, L 16 mm P5040.3801 iSy® Single patient form drill d 3.8 (3 piece) J5418.3310 Osteotome SCREW-LINE, angled convex d 3.3 mm J5420.3300 Osteotome SCREW-LINE, straight concave d 3.3 mm J5418.3810 Osteotome SCREW-LINE, angled convex d 3.8 mm J5420.3810 Osteotome SCREW-LINE, angled concave d 3.8 mm J5420.5000 Osteotome SCREW-LINE, straight concave d 5 mm J5420.4310 Osteotome SCREW-LINE, angled concave d 4.3 mm J5418.5010 Osteotome SCREW-LINE, angled convex d 5 mm J5418.3800 Osteotome SCREW-LINE, straight convex d 3.8 mm J5418.4310 Osteotome SCREW-LINE, angled convex d 4.3 mm J5420.3800 Osteotome SCREW-LINE, straight concave d 3.8 mm J5418.6010 Osteotome SCREW-LINE, angled convex d 6 mm J5420.6000 Osteotome SCREW-LINE, straight concave d 6 mm J5418.6000 Osteotome SCREW-LINE, straight convex d 6 mm J5420.5010 Osteotome SCREW-LINE, angled concave d 5 mm J5420.4300 Osteotome SCREW-LINE, straight concave d 4.3 mm J5417.2800 Pre-Osteotome SCREW-LINE, straight convex d 1.7-2.8 mm J5419.2800 Pre-Osteotome SCREW-LINE, straight concave d 1.7-2.8 mm J5420.6010 Osteotome SCREW-LINE, angled concave d 6 mm J5418030 Osteotomy Set CAMLOG®/ CONELOG® SCREW-LINE, angled convex J5420020 Osteotomy set CAMLOG®/ CONELOG® SL, str., concave J5420020 Osteotomy Set CAMLOG®/ CONELOG® SCREW-LINE, straight concave J5420.3310 Osteotome SCREW-LINE, angled concave d 3.3 mm J5418.4300 Osteotome SCREW-LINE, straight convex d 4.3 mm J5418.5000 Osteotome SCREW-LINE, straight convex d 5 mm J5418020 Osteotomy set CAMLOG®/ CONELOG® SL, str., convex J5418020 Osteotomy set CAMLOG®/ CONELOG® SCREW-LINE, straight convex J5418.3300 Osteotome SCREW-LINE, straight convex d 3.3 mm J5420030 Osteotomy set CAMLOG®/ CONELOG® SL, ang., concave J5418030 Osteotomy set CAMLOG®/ CONELOG® SL, ang., convex J5420030 Osteotomy Set CAMLOG®/ CONELOG® SCREW-LINE, angled concave

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EJL	Bur, Dental	Dental	Class 1	872.3240	2005-03-24
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2016-01-18
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2009-07-13
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2011-02-02
EMM	Chisel, Osteotome, Surgical	Dental	Class 1	872.4565	2005-03-24
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2013-01-03
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2013-01-03
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2008-12-11
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2014-08-13
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2014-08-13
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2015-10-13
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2015-10-13
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2015-02-18
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2016-04-01
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2020-10-08

Official Correspondent

Ruth Bauer

US Agent Details

Jared Cooper Email: jcooper@biohorizons.com Phone: (205) 9867994

Related Public Records

Same Entity

CAMLOG Biotechnologies GmbH

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
9613866	ALTATEC GMBH	WIMSHEIM Baden-Wurttemberg, DE

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K211871	Faico Medical, LLC	FAICO Dental Implant System and CAD/CAM Abutments	2021-11-18
K081806	Idi Biomedical, LLC	IDI IMPLANT SYSTEM	2008-11-07
K120793	Z-Systems AG	Z-LOOK3 EVO SLM	2012-12-21
K130140	Intra-Lock International	INTRA-LOCK OP DENTAL IMPLANT	2013-08-01
K925778	Nobelpharma USA, Inc.	BRANEMARK SYSTEM LAB. AND EDUCATIONAL ACCESSORIES	1993-04-14

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0007-2018	Implant Direct Sybron Manufacturing, LLC	2	Implant Direct Swish Duo-Grip Healing Collar, Length: 3mm, Platform: 4.8 mm, Rx only, Sterile Dental Implant component.
Z-0010-2020	Implant Direct Sybron Manufacturing, LLC	2	ImplantDirect simply RePlant Implant, size 4.3mmD x 13mmL, 4.3mmD Platform, REF 604313U, Rx, Sterile. The firm name on the label is Implant Direct Sybron Manufacturing LLC, Thousand Oaks, CA.
Z-0017-2026	S.I.N. Implant System Ltda Rua Soldador Ocimar Guimaraes da Silva 421 Jardim Analia Franco Sao Paulo Brazil	2	IMPLANT EPIKUT PLUS MT16 3,5X10,0MM, REF: ILM 3510N; IMPLANT EPIKUT PLUS MT16 3.8X11.5MM, REF: ILM 3511N; IMPLANT EPIKUT PLUS MT16 3,5X13,0MM, REF: ILM 3513N; IMPLANT EPIKUT PLUS MT16 3,5X15,0MM, REF: ILM 3515N; IMPLANT EPIKUT PLUS MT16 3,8X10,0MM, REF: ILM 3810N; IMPLANT CM16 3,8 X 11MM, REF: ILM 3811N; IMPLANT EPIKUT PLUS MT16 3,8X15,0MM, REF: ILM 3815N; IMPLANT EPIKUT PLUS MT16 4,0X10,0MM, REF: ILM 4010N; IMPLANT EPIKUT PLUS MT16 4,0X11,5MM, REF: ILM 4011N; IMPLANT EPIKUT PLUS MT16 4,0X13,0MM, REF: ILM 4013N; IMP EPIKUT PLUS LONG MT16 4,0X20,0MM, RES: ILM 4020N; IMPLANT EPIKUT PLUS MT16 4,0X8,5MM, RES: ILM 4085N; IMPLANT EPIKUT PLUS MT16 4,5X13,0MM, REF: ILM 4513N; IMPLANT EPIKUT PLUS MT16 4,5X15,0MM, REF: ILM 4515N; IMPLANT EPIKUT PLUS MT16 4,5X8,5MM, REF: ILM 4585N; IMPLANT EPIKUT PLUS MT16 5,0X10,0MM, REF: ILM 5010N; IMPLANT EPIKUT PLUS MT16 5,0X11,5MM, REF: ILM 5011N; IMPLANT EPIKUT PLUS MT16 4,5X10,0MM, REF: ILM 4510N; IMPLANT EPIKUT PLUS MT16 5,0X13,0MM, RES: ILM 5013N; IMPLANT EPIKUT PLUS MT16 5,0X15,0MM, REF: ILM 5015N; IMPLANT EPIKUT PLUS MT16 5,0X8,5MM, REF: ILM 5085N; IMP EPIKUT PLUS LONG MT16 4,0X18,0MM, REF: ILM 4018N; IMP EPIKUT PLUS LONG MT16 3,8X18,0MM, REF: ILM 3818N; IMPLANT EPIKUT PLUS MT16 4,5X11,5MM, REF: ILM 4511N; IMPLANT EPIKUT MT16 4,5X15,0MM, REF: ILM 4515; IMPLANT EPIKUT MT16 4,5X8,5MM, REF: ILM 4585; IMPLANT EPIKUT MT16 3,8X13,0MM, REF: ILM 3813; IMPLANT EPIKUT MT16 3,8X15,0MM, REF: ILM 3815; IMPLANT EPIKUT MT16 5,0X8,5MM, REF: ILM 5085; IMPLANT EPIKUT MT16 3,8X11,5MM, REF: ILM 3811; IMPLANT EPIKUT PLUS MT16 3,8X20,0MM, REF: ILM 3820N; IMPLANT EPIKUT PLUS MT16 4,5X18,0MM, REF: ILM 4518N; IMPLANT UNITITE MORSE COMPACT 6.0X7MM, REF: UCMC 6007N
Z-0018-2020	Implant Direct Sybron Manufacturing, LLC	2	ImplantDirect Legacy 3 Implant, REF 855216, SBM implant assembly, 2mmD x 16mmL, 4.5mmD platform, Rx, Sterile. The mislabeled model/part number on the vial cap is 835216. The responsible firm on the label is Implant Direct Sybron Manufacturing LLC, Thousand Oaks, CA. - Product Usage:Implant Direct Sybron Manufacturing LLC s dental implant product line consists of one-piece and two-piece implants for one-stage or two-stage surgical procedures. These implants are intended for use in partially and fully edentulous upper and lower jaws in support of single or multiple-unit restorations and terminal or intermediate abutment support for fixed bridgework.
Z-0019-2020	Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel	2	Paltop Advanced Plus Dental Implant Dia 6.0mm L10mm Catalog Number: 20-70024P

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007283751. Last updated year: 2026. Please use registration number 3007283751 when referencing this establishment in official correspondence.