Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003637274

FEI Number

3003637274

Entity Name

KAVO DENTAL GMBH

City/State/Country

WARTHAUSEN Baden-Wurttemberg, DE

Establishment Address

BAHNHOFSTRASSE 20, WARTHAUSEN Baden-Wurttemberg 88447, DE

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

KaVo Dental GmbH (Owner Number: 10042139)

Owner / Operator Contact Address

Bismarckring 39, Biberach, DE-BW 88400, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K140308

PMA Number

N/A

All Registered Proprietary Names

102.7000 - DIAGNOdent pen 2190 102.8568 - DIAGNOdent Paro Tip Saphir with scale 104370 - DIAGNOdent Paro Tip Saphir without scale 104.8400 - DIAGNOdent Display 2191 108.2700 - KaVoLUX 540 LED Dental Operating Lights 110.1826 - KaVo PROPHYpearls neutral 107014 - PROPHYflex powder orange 107015 - PROPHYflex powder berry 110.1830 - KaVo PROPHYpearls orange 102342 - PROPHYpearls 110.1798 - KaVo PROPHYpearls neutral 109.3732 - KaVo PROPHYflex Perio Powder 110.1829 - KaVo PROPHYpearls peach 110.1831 - KaVo PROPHYpearls black currant 107017 - PROPHYflex powder mint 107641 - PROPHYflex powder mailing 107016 - PROPHYflex powder cherry 110.1828 - KaVo PROPHYpearls mint PIEZO Scaler Tip 203 - 107.4028 PIEZO Scaler Tip 201 - 107.4024 PIEZO Prep Tip 227 - 107.4036 PIEZO Prep Tip 226 - 107.4035 PIEZO Prep Tip 228 - 107.4037 PIEZO Implant Refill Tip Set - 107.4014 PIEZO Cem Tip 225 - 107.4027 PIEZO Implant Tip Set - 107.4008 PIEZO Prep Tip 229 - 107.4038 PIEZO Endo Tip 220 - 107.4040 PIEZO Paro Tip Set - 107.4006 PIEZO Scaler Tip Set - 107.4004 PIEZO Paro Tip 211 - 107.4042 PIEZO Scaler Tip 202 - 107.4026 PIEZO Paro Tip 214 - 107.4034 PIEZO Endo Tip 221 - 107.4041 PiezoLED - 107.3995 PIEZO Paro Tip 213 - 107.4033 PIEZO Paro Tip 212 - 107.4032 PIEZO Paro Tip 210 - 107.4039 PIEZO Endo Tip 222 - 107.4043 0.571402 - SONICflex clean Brush No. 1 104.3874 - SONICflex bone Set 100.4246 - SONICflex 2003 105.9328 - SONICflex scaler Tipset (A) 106.2022 - SONICflex rootplaner Tipset (A) 0.571.5651 - SONICflex rootplaner Tip No. 27 102.1988 - SONICflex prep CAD-CAM Tipset 0.571.7262 - SONICflex prep ceram Tip No. 51 106.1971 - SONICflex micro Tip No. 31 (A) 107.1607 - SONICflex 2008 S (Set) 100.7167 - SONICflex cari-ex 1.2 No. 43 100.5821 - SONICflex endo Tip No. 70 106.1936 - SONICflex paro Tip No.62 (A) 106.1973 - SONICflex micro Tip No. 32 (A) 106.2036 - SONICflex retro Tip No. 16 (A) 106.2006 - SONICflex bone Tip No. 80 (A) 100.8333 - SONICflex 2003 L (Set) 100.7105 - SONICflex cari-ex 0.8 No. 42 0.571.5601 - SONICflex retro, left 106.2010 - SONICflex bone Tip No. 82 (A) 106.2025 - SONICflex cari-ex D Tipset (A) 0.571.5431 - SONICflex cem Tip No. 12 106.2028 - SONICflex prep gold Tipset (A) 105.9310 - SONICflex 2008 L 106.1979 - SONICflex prep CAD/CAM No. 35 (A) distal 106.2029 - SONICflex prep ceram Tipset (A) 0.571432 - SONICflex clean Brush No. 4 106.2038 - SONICflex retro Tip No. 21 (A) 106.2014 - SONICflex bone Tip No. 84 (A) 100.1980 - SONICflex cari-ex 0.8 No. 42 (A) 0.571.5521 - SONICflex retro Tip No. 20 106.1934 - SONICflex paro Tip No.60 (A) 106.1935 - SONICflex paro Tip No.61 (A) 106.2034 - SONICflex retro Tipset (A) 106.2021 - SONICflex cemTip No. 12 (A) 106.2012 - SONICflex bone Tip No. 83 (A) 107541 - SONICflex 2008 S 106.1953 - SONICflex scaler Tip No. 8 (A) 100.1992 - SONICflex endo Tip No. 66 (A) 0.571.5611 - SONICflex retro, right 106.1986 - SONICflex prep ceram Tip No. 52 A 106.1965 - SONICflex micro Tip No. 28 (A) 105.9311 - SONICflex 2008 106.1982 - SONICflex clean Tip No.48 (A) 102.1986 - CAD-CAM distal gebogen No.35 100.5825 - SONICflex endo Tip No. 66 100.4983 - SONICflex scaler Tipset 100.5828 - SONICflex endo Tipset 106.2035 - SONICflex retro Tip No. 17 (A) 106.1990 - SONICflex bevel Tip No. 59 (A) 108.6386 - SONICflex prep crown plain Nr.98 A 106.1963 - SONICflex rootplaner Tip No. 27 (A) 0.571.7212 - SONICflex prep gold Tip No. 49 0.571.6741 - SONICflex micro Tip No. 28 0.571.5191 - SONICflex scaler Tip No. 7 0.571.5181 - SONICflex scaler Tip No. 6 105.8949 - SONICflex scaler Tip No. 5 (A) 106.2024 - SONICflex bone Tip No. 85 (A) 104.3878 - SONICflex bone Tip No. 83 0.571.6731 - SONICflex micro Tip No. 29 0.571421 - SONICflex micro Tipset 0.571371 - SONICflex paro Tipset 0.571.7402 - SONICflex paro Tip No.60 106.1969 - SONICflex micro Tip No. 30 (A) 0.571.7392 - SONICflex bevel Tip No. 58 106.2030 - SONICflex bevel Tipset (A) 106.2023 - SONICflex micro Tipset (A) 100.7379 - SONICflex cari-ex TC Tipset 106.1988 - SONICflex bevel Tip No. 58 (A) 0.571.5621 - SONICflex rootplaner Tip No. 24 0.571.7322 - SONICflex retro Tip No. 56 106.1967 - SONICflex micro Tip No. 29 (A) 103.8167 - SONICflex implant Set 106.1959 - SONICflex rootplaner Tip No. 25 (A) 106.2026 - SONICflex clean Brushset (A) 106.2002 - SONICflex cari-ex 1 No. 71 (A) 0.571.6811 - SONICflex micro Tip No. 30 0.571.6801 - SONICflex micro Tip No. 31 0.571321 - SONICflex prep gold Tipset 108.6384 - SONICflex prep crown round Nr.97 A 100.4243 - SONICflex 2003 L 105.8951 - SONICflex scaler Tip No. 7 (A) 106.2040 - SONICflex retro Tip No. 56 (A) 107.1604 - SONICflex 2008 L (Set) 100.7362 - SONICflex cari-ex 1 No. 71 100.5823 - SONICflex endo Tip No. 68 106.2037 - SONICflex retro Tip No. 20 (A) 100.1981 - SONICflex cari-ex 1.2 No. 43 (A) 102.1984 - CAD-CAM mesial gebogen No.34 0.571391 - SONICflex bevel Tipset 106.2008 - SONICflex bone Tip No. 81 (A) 100.7378 - SONICflex cari-ex D Tipset 105.8950 - SONICflex scaler Tip No. 6 (A) 106.2024 - SONICflex prep CAD-CAM Tipset (A) 0.571301 - SONICflex rootplaner Tipset 106.2004 - SONICflex cari-ex 1.4 No. 72 (A) 100.5827 - SONICflex endo Tip No. 69 100.1996 - SONICflex endo Tip No. 68 (A) 104.3877 - SONICflex bone Tip No. 82 106.2026 - SONICflex bone Tip No. 87 (A) 106645 - SONICflex bone Tip No. 85 106.1984 - SONICflex prep gold Tip No. 50 (A) 104.3876 - SONICflex bone Tip No. 81 100.7363 - SONICflex cari-ex 1.4 No. 72 107.1503 - SONICflex seal Tip No.45 (A) 0.571.7222 - SONICflex prep gold Tip No. 50 107540 - SONICflex 2008 LS 0.571401 - SONICflex clean Tip No. 48 0.571.6821 - SONICflex micro Tip No. 33 0.571422 - SONICflex clean Brush No. 3 0.571001 - SONICflex clean Brushset 0.571.5561 - SONICflex retro Tip No. 21 0.571.5171 - SONICflex scaler Tip No. 5 0.571472 - SONICflex clean Brush No. 5 0.571.5371 - SONICflex scaler Tip No. 8 100.2000 - SONICflex endo Tip No. 70 (A) 106.1961 - SONICflex rootplaner Tip No. 26 (A) 106741 - SONICflex bone Tip No. 86 0.571.7412 - SONICflex paro Tip No.61 100.2568 - SONICflex seal Tip No. 45 106.2031 - SONICflex endo Tipset (A) 0.571.5641 - SONICflex rootplaner Tip No. 26 107.1605 - SONICflex 2008 LS (Set) 100.5822 - SONICflex endo Tip No. 67 106.2032 - SONICflex cari-ex TC Tipset (A) 106.2020 - SONICflex paro Tipset (A) 0.571412 - SONICflex clean Brush No. 2 0.571.7342 - SONICflex retro Tip No. 55 106.1985 - SONICflex prep ceram Tip No. 51 (A) 0.571.5631 - SONICflex rootplaner Tip No. 25 104.3875 - SONICflex bone Tip No. 80 0.571.6831 - SONICflex micro Tip No. 32 0.571.5581 - SONICflex retro Tip No. 17 100.8334 - SONICflex 2003 (Set) 106.2025 - SONICflex bone Tip No. 86 (A) 104.3879 - SONICflex bone Tip No. 84 103.8168 - SONICflex implant refill 100.1994 - SONICflex endo Tip No. 67 (A) 106.1406 - SONICflex bone Tip No. 87 106.2041 - SONICflex retro Tip No. 57 (A) 106.2033 - SONICflex bone Set (A) 106.1957 - SONICflex rootplaner Tip No. 24 (A) 107.1606 - SONICflex 2008 (Set) 0.571.7382 - SONICflex bevel Tip No. 59 0.571331 - SONICflex prep ceram Tipset 0.571.5541 - SONICflex retro Tip No. 16 0.571.7332 - SONICflex retro Tip No. 57 0.571.7422 - SONICflex paro Tip No.62 0.571381 - SONICflex retro Tipset 100.1998 - SONICflex endo Tip No. 69 (A) 0.571482 - SONICflex clean Brush No. 6 106.1977 - SONICflex prep CAD/CAM No. 34 (A) mesial 106.2039 - SONICflex retro Tip No. 55 (A) 0.571.7272 - SONICflex prep ceram Tip No. 52 106.1975 - SONICflex micro Tip No. 33 (A) 106.2027 - SONICflex implant Set A 106.1983 - SONICflex prep gold Tip No. 49 (A) 108.6383 - SONICflex prep crown round tip no. 97 108.6385 - SONICflex prep crown plain tip no. 98 0.773000 - Multifunction LUX Syringe 0.773510 - 3-Function Syringe 109.2724 - 3-Function Syringe 0.773010 - Multifunction LUX Syringe 0.773500 - 3-Function Syringe 109.7840 - 3-Function Syringe 300.4808 - SURGtorque LUX S459 L 300.5063 - SURGtorque S459 C 108.1644 - SMARTtorque S609 C 108.1645 - SMARTtorque Mini S605 C 108.1641 - SMARTtorque LUX S619 L 108.1642 - SMARTtorque S619 C 108.1643 - SMARTtorque Mini LUX S615 L 110.1010 - DEXIS CariVu 104.1640 - DIAGNOdent 2095 perio tip SMARTmatic PROPHY S19 - 111.6740 SMARTmatic PROPHY S31 K - 111.6761 SMARTmatic S20 S - 111.6752 SMARTmatic S10 K - 111.6731 SMARTmatic S10 S - 111.6732 SMARTmatic S10 - 111.6730 SMARTmatic ENDO S81 - 111.6780 SMARTmatic ENDO S321 - 111.6790 SMARTmatic S80 K - 111.6771 elements 8:1 - 111.6786 SMARTmatic PROPHY S31 - 111.6760 SMARTmatic S20 - 111.6750 SMARTmatic S53 - 111.6810 SMARTmatic S20 K - 111.6751 SMARTmatic PROPHY S19 K - 111.6741 SMARTmatic PROPHY S33 - 111.6800 0.535.5250 - INTRAmatic 181 M 0.535.5260 - INTRA 181 K 20 000 R.P.M. 0.535.5210 - INTRA L-LUX 181 L 0.535.5200 - INTRA-L-MOTOR 181 H 107.1700 - GENTLEmini LUX 4500BR 101.8776 - INTRA LUX Motor KL 701 107.3600 - EXPERTtorque Mini LUX E677 L 107.3580 - GENTLEpower LUX 25 LPR 0.535.6200 - INTRAflex LUX2 2329 LN 103.9882 - Trio-Pack 181P/181P/181P 107.5530 - EXPERTmatic E15 L 104.4503 - INTRAmatic 19 ES 101.7522 - POWERtorque 646 B 107.2400 - GENTLEsilence LUX 6500 BR 0.535.6220 - INTRAflex LUX2 2313 LN 106800 - EXPERTtorque E675 LMW 107.5540 - EXPERTmatic E20 L 103.1107 - INTRAmatic 20 E 0.553820 - COMPACTtorque 636 CP 103.6976 - INTRAmatic 31 E 108.1825 - INTRA Mini Kopf L52 108.1828 - INTRA EVA Kopf L61 G 108.1832 - INTRA Kopf L67 101.7454 - GENTLEpower LUX 29 LP 104.4456 - INTRA Kopf L80 103.6977 - INTRAmatic 10 E 108.1822 - INTRA Endo Kopf L3 107.5531 - EXPERTmatic E15 C 0.535.6190 - INTRAflex LUX2 2307 LN 103.2278 - PROPHYwiz 181 P 0.535.6210 - INTRAflex LUX2 2325 LN 101.7452 - GENTLEpower LUX 7 LP 106780 - GENTLEsilence LUX gold 8000 BR 106.6400 - EXPERTtorque E675 L 104.6403 - INTRAmatic 19 E 104.6401 - INTRAmatic 80 E 103.1109 - INTRAmatic 31 ES 107.5560 - EXPERTmatic E10 C 107.5550 - EXPERTmatic E25 L 0.535.6180 - INTRAflex LUX2 2320 LN 104.5380 - INTRAmatic 23 ES 101.5660 - GENTLEpower LUX 10 LP 103.1108 - INTRAmatic 14 E 108.4999 - EXPERTmatic E61 C 106.9200 - EXPERTtorque E679 L 108.1823 - INTRA Endo Kopf L3 Y 107.5551 - EXPERTmatic E25 C 107.5541 - EXPERTmatic E20 C 101.7453 - GENTLEpower LUX 20 LP 108.1829 - INTRA EVA Kopf L61 R 108.4998 - EXPERTmatic E31 C 108.1830 - INTRA Kopf L62 108.1835 - INTRA Micro Kopf L22 108.1824 - INTRA Prophy Kopf L31 108.1826 - INTRA Endo Kopf L53 108.1834 - INTRA Kopf L68 B 108.1831 - INTRA Kopf L66 B 108.1833 - INTRA Kopf L68 105900 - ARCUSevo 0.622.5000 - ARCUS 105.5000 - COMFORTdrive System 105169 - COMFORTtronic 4894 107.3570 - COMFORTdrive 200XDR 103.5622 - INTRAmatic LUX 702 KL 102.5015 - ELECTROtorque plus (Set) 101.8748 - ELECTROtorque plus 107150 - INTRAmatic KL 703 LED 103.3490 - ELECTROtorque TLC 4893 103.5840 - ELECTROtorque TLC 4893 (Set) 115960 - INTRA LUX KL703 LED Planmeca 0.574500 - DIAGNOdent 2095 0.411.9650 - KaVo Spray AMERICA 2113 105.3844 - QUATTROcare plus Spray AMERICA 2141 105.4524 - QUATTROcare plus Spray AMERICA 2141 (Set) 108525 - SonicFill Handpiece Lubrication Spray 0.411.9660 - KaVo Spray AMERICA 2113 (Set) 108.3805 - QUATTROcare PLUS 2124 A 302.8200 - PROPHYflex 4 Lime 113.4400 - PROPHYpearls Selection 304.5900 - PROPHYflex 4 S Wave 111.9403 - PROPHYflex 4 Perio Kit 304.5950 - PROPHYflex 4 S Flamingo 200922 - PROPHYflex perio tip 111.9400 - Adapter perio tip 304.5930 - PROPHYflex 4 S Lime 302.8000 - PROPHYflex 4 Wave 302.8800 - PROPHYflex 4 Flamingo 112.1000 - Power cannula 303.1138 - Cannula 110287 - Refill PROPHYflex perio tip 109.8757 - Tube Set S600 111.4444 - DEXIS CariVu 3-in-1 by KaVo 113.1700 - DEXIS CariVu 3-in-1 by KaVo U 111.1213 - DIAGNOcam Vision Full HD 113.1500 - DIAGNOcam Vision Full HD 115.3700 - DIAGNOcam Vision Full HD 109.1100 - SURGmatic S201 C 110.2332 - SURGmatic S201 XL 110.2333 - SURGmatic S201 XC 108.8000 - INTRA LUX S600 LED 109.1005 - SURGmatic S11 C 109470 - SURGmatic S201 L 109.8757 - Tube Set S600 109.1200 - MASTERsurg LUX 108.3500 - EXPERTsurg LUX 109.1010 - SURGmatic S11 L 111.4900 - SM5 110.8042 - Demo Unit EXPERTsurg LUX 110.9726 - Demo Unit MASTERsurg LUX 113.8662 - SURGmatic Head S201 XL Pro 113.7540 - SURGmatic S201 L Pro 113.8648 - SURGmatic Head S201 L Pro 113.7541 - SURGmatic S201 XL Pro

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NTK	Caries Detector, Laser Light, Transmission	Dental	Class 2	872.1745	2012-10-26
EAZ	Light, Operating, Dental	Dental	Class 1	872.4630	2012-10-26
EJR	Agent, Polishing, Abrasive, Oral Cavity	Dental	Class 1	872.6030	2015-10-16
ELC	Scaler, Ultrasonic	Dental	Class 2	872.4850	2017-01-18
ELC	Scaler, Ultrasonic	Dental	Class 2	872.4850	2012-10-26
ECB	Unit, Syringe, Air And/Or Water	Dental	Class 1	872.4565	2012-10-26
EFB	Handpiece, Air-Powered, Dental	Dental	Class 1	872.4200	2012-10-26
NTK	Caries Detector, Laser Light, Transmission	Dental	Class 2	872.1745	2013-10-24
NBL	Laser, Fluorescence Caries Detection	Dental	Class 2	872.1745	2012-10-26
EFA	Handpiece, Belt And/Or Gear Driven, Dental	Dental	Class 1	872.4200	2017-03-20
EFB	Handpiece, Air-Powered, Dental	Dental	Class 1	872.4200	2012-10-24
EJP	Articulators	Dental	Class 1	872.3150	2012-10-26
EFB	Handpiece, Air-Powered, Dental	Dental	Class 1	872.4200	2012-10-26
EIA	Unit, Operative Dental	Dental	Class 1	872.6640	2012-10-26
EKX	Handpiece, Direct Drive, Ac-Powered	Dental	Class 1	872.4200	2012-10-26
EBW	Controller, Foot, Handpiece And Cord	Dental	Class 1	872.4200	2012-10-26
NBL	Laser, Fluorescence Caries Detection	Dental	Class 2	872.1745	2012-10-26
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2012-10-26
EFB	Handpiece, Air-Powered, Dental	Dental	Class 1	872.4200	2019-04-29
EFS	Unit, Oral Irrigation	Dental	Class 1	872.6510	2017-12-19
NTK	Caries Detector, Laser Light, Transmission	Dental	Class 2	872.1745	2019-11-26
NBL	Laser, Fluorescence Caries Detection	Dental	Class 2	872.1745	2019-11-26
EBW	Controller, Foot, Handpiece And Cord	Dental	Class 1	872.4200	2014-08-18

Official Correspondent

No official correspondent registered.

US Agent Details

Crystal Bialek Business: KaVo Dental Technologies, LLC Email: crystal.bialek@kavo.com Phone: (704) 2886058

Related Public Records

Same Entity

KaVo Dental 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
8010493	KAVO DENTAL GMBH	BIBERACH Baden-Wurttemberg, DE

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K121698	Dentsply International, Inc.	NUPRO SENSODYNE PROPHYLAXIS PASTE WITH NOVAMIN	2012-08-06
K832443	California Technics, Inc.	ULTRASONIC DENTAL PROPHYLAXIS UNIT	1983-09-12
K994299	Bonart Co., Ltd.	ART-P3, MODEL P3-1-ART-A1	2000-03-06
K212910	Shenzhen Carejoy Technology Co., Ltd.	Dental High-speed Turbine Handpiece, Dental Low-speed Turbine Handpiece	2022-11-17
K241065	Dentis Co., Ltd.	ChecQ (AC100)	2025-03-21

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0028-2020	Voco GmbH Anton-Flettner-Str. 1-3 Cuxhaven Germany	2	Grandio SO Heavy Flow Caps, Color A3 - Product Usage: Filling minimally invasive cavities of all classes - Filling small class I cavities and extended fissure sealing - Filling class II - V cavities including V-shaped defects and cervical caries - Blocking out undercuts - Lining or coating cavities - Repairing fillings and veneers - Luting translucent prosthetic pieces (e.g., full ceramic crowns, etc.).

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003637274. Last updated year: 2026. Please use registration number 3003637274 when referencing this establishment in official correspondence.