PRECISION ONE MEDICAL

FDA Device Registration & Listing · Oceanside, CA, US · Registration 3009201148

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3009201148
FEI Number
3009201148
Entity Name
PRECISION ONE MEDICAL
City/State/Country
Oceanside, CA, US
Establishment Address
3923 OCEANIC DR STE 200, Oceanside, CA 92056, US
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
Precision One Medical (Owner Number: 10042281)
Owner / Operator Contact Address
3923 Oceanic Dr., Suite 200, Oceanside, CA 92056, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

3.5mm Multi-unit Abutment, 30-degree, 4mm Collar Internal 4.5 Regular Emergence 3inOne Abutment 4.5mm Multi-unit Abutment, Straight 4mm Collar 4.5mm Multi-unit Abutment, 17-degree, 3mm Collar 4.5mm Multi-unit Abutment, 30-degree, 3mm Collar 4.5mm Multi-unit Abutment, Straight 3mm Collar Internal 4.5mm Regular Emergence Angled Abutment 5.7mm Multi-unit Abutment, Straight 1mm Collar Internal/Single-stage Abutment Screw Internal 5.7mm Laser-Lok Titanium Base Abutment 4.5mm Multi-unit Abutment, Straight 2mm Collar Discontinued - 5.7mm Regular Emergence Angled Abutment, Machined Internal 5.7mm Straight Esthetic Abutment, 3mm Buccal Discontinued - Internal 3.5mm Straight Esthetic Abutment, 3mm Margin Machined Internal 3.5 Regular Emergence 3inOne Abutment Internal 5.7mm Angled Esthetic Abutment Internal 4.5mm Straight Esthetic Abutment, 3mm Buccal 3.5mm Multi-unit Abutment, 17-degree, 2.25mm Collar Internal 4.5mm Angled AFS, 15 Degree 5.7mm Multi-unit Abutment, Straight 2mm Collar Discontinued - Internal 4.5mm Straight Esthetic Abutment, 3mm Margin Machined Discontinued - 3.5mm Internal Straight Esthetic Abutment, Machined 4.5mm Multi-unit Abutment, 30-degree, 5mm Collar Internal 5.7 Regular Emergence 3inOne Abutment 4.5mm Multi-unit Abutment, 30-degree, 4mm Collar Prosthetic Screw, Multi-unit, Long (pack of 5) 3.5mm Multi-unit Abutment, Straight 2mm Collar Internal 3.5mm Straight Esthetic Abutment Discontinued - 3.5mm Regular Emergence Angled Abutment, Machined 3mm Multi-unit Abutment, 17-degree, 2.25mm Collar 3.5mm Multi-unit Abutment, Straight 5mm Collar 3.5mm Multi-unit Abutment, 30-degree, 5mm Collar Internal 3.5mm Regular Emergence Angled Abutment Discontinued - 5.7MM 3INONE ABUTMENT 4.5mm Multi-unit Abutment, 17-degree, 4mm Collar Internal 5.7mm Regular Emergence Angled Abutment Internal 4.5mm Angled AFS, 25 Degree Discontinued - 4.5mm Regular Emergence Angled Abutment, Machined Discontinued - 4.5MM 3INONE ABUTMENT Discontinued - 5.7mm Internal Angled Esthetic Abutment Discontinued - 3.5mm Internal Angled Esthetic Abutment, Machined Internal 4.5mm Laser-Lok Titanium Base Abutment 3mm Multi-unit Abutment, 17-degree, 3mm Collar Internal 3.5mm Angled Esthetic Abutment Internal 4.5mm Straight Esthetic Abutment 4.5mm Multi-unit Abutment, Straight 1mm Collar Discontinued - 5.7mm Internal Straight Esthetic Abutment, Machined Internal 3.5mm Straight Esthetic Abutment, 3mm Buccal Internal 5.7mm Straight Esthetic Abutment Discontinued - 4.5mm Internal Angled Esthetic Abutment, Machined Prosthetic Screw, Multi-unit, Regular (pack of 5) Abutment Screw, Multi-unit Abutment Internal 4.5mm Angled Esthetic Abutment Internal 3.5mm Laser-Lok Titanium Base Abutment 3.5mm Multi-unit Abutment, Straight 3mm Collar Internal 3.5mm Angled AFS, 17.5 Degree Discontinued - Internal 5.7mm Straight Esthetic Abutment, 3mm Margin Machined 4.5mm Multi-unit Abutment, Straight 5mm Collar 3.5mm Multi-unit Abutment, 17-degree, 3mm Collar Discontinued - 4.5mm Internal Straight Esthetic Abutment 4.5mm Multi-unit Abutment, 17-degree, 2.25mm Collar Plastic Coping, Multi-unit Discontinued - 3.5mm 3inOne Abut Regular Emergence, Mach'd 3mm Custom Temporary Abutment Sleeve 3mm Crestal Bone Drill 3mm Angled Esthetic Abutment Discontinued - 3 Straight Esthetic Abutment, 3mm Buccal 3mm Two-piece Custom Temporary Abutment, 3mm Height 3mm Straight Esthetic Abutment, Laser-Lok 3mm Cover Cap 3mm Two-piece Custom Temporary Abutment, 1mm Height Discontinued - 3mm Angled Esthetic Abutment Discontinued - Two-piece 3 Straight Esthetic Abutment 3mm Straight Esthetic Abutment 3mm Angled Esthetic Abutment, Laser-Lok 3mm Straight Esthetic Abutment, 3mm Buccal, Laser-Lok 3mm Straight Esthetic Abutment, 3mm Buccal THE AUTOTAC SYSTEM TITANIUM TACK 511401 441802 406801 511501 563601 563701 406002 407502 Screw Removal Kit NobRpl Healing Abutment MODIFICATION TO THE MAESTRO SYSTEM External 5mm Abutment for Screw, 3.5mm Collar Starter Drill External 3.5mm Abutment for Screw, 3.5mm Collar Internal/Single-stage Abutment Screw Intra-Lock International Angled Prosthetic Abutments Intra-Lock MILO Implant System; Intra-Lock Angled Prosthetic Abutments 2542602 2543001 2542601 2542603 2542502 2542903 2543101 2542702 2543002 2542901 2542701 2542902 2542801 2542802 2543102 2542501 Intra-Lock System Abutments; Intra-Lock Dental Implants Intra-Lock Mini Drive-Lock Dental Implant System BIOHORIZONS TAPERED INTERNAL PLUS IMPLANTS THE MAESTRO SYSTEM Discontinued - 3.5mm Ti-N Angled Esthetic Abutment, Machined External 4mm Angled Esthetic Abutment, Hexed External 5mm 3inOne Abutment, Hexed External 4mm 3inOne Abutment, Hexed External 3.5mm Angled Esthetic Abutment, Hexed Discontinued - 4mm Ti-N Angled Esthetic Abutment, Machined External 3.5mm 3inOne Abutment, Hexed External 5mm Angled Esthetic Abutment, Hexed External 6mm 3inOne Abutment, Hexed Internal 5.7mm Straight Esthetic Abutment, Laser-Lok Internal 3.5mm Angled Esthetic Abutment, Laser-Lok Discontinued - Internal 3.5mm Straight Esthetic Abutment, 3mm Margin Machined Discontinued - 5.7mm Internal Straight Esthetic Abutment, Machined Discontinued - 5.7mm Internal Angled Esthetic Abutment Discontinued - 4.5mm Internal Straight Esthetic Abutment Internal 3.5mm Straight Esthetic Abutment Discontinued - Internal 5.7mm Straight Esthetic Abutment, 3mm Margin Machined 5.7mm 20 Degree Angled Abutment (Regular Emergence) Discontinued - 3.5mm Internal Angled Esthetic Abutment, Machined 4.5mm Dual Purpose Abutment (Regular Emergence) Internal 3.5mm Straight Esthetic Abutment, 3mm Buccal Internal 4.5mm Angled Esthetic Abutment Internal 4.5mm Straight Esthetic Abutment, Laser-Lok Internal 4.5mm Straight Esthetic Abutment Internal 5.7mm Straight Esthetic Abutment Internal 4.5mm Straight Esthetic Abutment, 3mm Buccal 4.5mm 20 Degree Angled Abutment (Regular Emergence) Internal/Single-stage Abutment Screw Internal 3.5mm Angled Esthetic Abutment 3.5mm 20 Degree Angled Abutment (Regular Emergence) Discontinued - 3.5mm 3inOne Abut Regular Emergence, Mach'd Internal 3.5mm Straight Esthetic Abutment, 3mm Buccal, Laser-Lok Discontinued - Internal 4.5mm Straight Esthetic Abutment, 3mm Margin Machined Discontinued - 3.5mm Internal Straight Esthetic Abutment, Machined Internal 5.7mm Straight Esthetic Abutment, 3mm Buccal Internal 5.7mm Angled Esthetic Abutment, Laser-Lok BioHorizons Tapered Internal Implant Internal 3.5 Regular Emergence 3inOne Abutment Discontinued - 4.5mm Internal Angled Esthetic Abutment, Machined Internal 3.5mm Straight Esthetic Abutment, Laser-Lok 5.7mm Dual Purpose Abutment (Regular Emergence) Internal 4.5mm Angled Esthetic Abutment, Laser-Lok Internal 5.7mm Angled Esthetic Abutment 3.5mm Dual Purpose Abutment (Regular Emergence) Internal 4.5mm Straight Esthetic Abutment, 3mm Buccal, Laser-Lok Internal 5.7mm Straight Esthetic Abutment, 3mm Buccal, Laser-Lok 2542401 2411702 2411701 BioHorizons Tapered IM Implants BIOHORIZONS DENTAL IMPLANT SYSTEM 3.45mm x 15 Degree Angled Abutment, Micro-Lok 4mm x 15 Degree Angled Abutment, Micro-Lok 3.45mm Plastic Castable Abutment, Hexed 4mm x 25 Degree Angled Abutment, Micro-Lok 4mm Plastic Castable Abutment, Non-hexed BioHorizons Tapered Short Implants MODIFICATION TO THE MAESTRO SYSTEM 2413001 Intra-Lock International Endossous Implant & Abutment System BIOHORIZONS INTERNAL IMPLANT SYSTEM Laser-Lok Angled Esthetic Abutment for Nobel, WP Laser-Lok Straight Esthetic Abutment for Nobel, WP, 3mm Buccal Laser-Lok Straight Esthetic Abutment for Nobel, RP, 3mm Buccal Laser-Lok Straight Esthetic Abutment for Nobel, RP Laser-Lok Angled Esthetic Abutment for Nobel, NP Laser-Lok Straight Esthetic Abutment for Nobel, NP Laser-Lok Straight Esthetic Abutment for Nobel, WP RP/WP Tri-Channel Abutment Screw for Nobel Laser-Lok Straight Esthetic Abutment for Nobel, NP, 3mm Buccal Laser-Lok Angled Esthetic Abutment for Nobel, RP NP Tri-Channel Abutment Screw for Nobel Tapered 5.4mm Width Incr.Drill, Ext Shank 4.9mm Width Increasing Drill 3.8mm Tapered Depth Gauge Tapered 3.8mm Crestal Bone Drill 2 x 17mm CGS Pilot Drill Tapered 4.6mm Bone Tap 2.5mm Tapered Depth Drill, 15mm Stop 30 Degree Angled Parallel Pin 2.5 x 15mm Depth Drill Tapered 5.4mm Width Increasing Drill 2 x 24mm CGS Pilot Drill Tapered 3.7mm Width Increasing Drill Discontinued - Internal 4.5 Implant Analog 2.5mm Tapered Depth Drill, 12mm Stop 2.5 x 12mm Depth Drill Tapered 5.8mm Crestal Bone Drill 5.4mm Width Increasing Drill Tapered 2mm Starter Drill, Ext Shank Tapered 3 Depth Gauge 2.5 x 10.5mm Depth Drill - Extended Shank 4.4mm Width Increasing Drill Tapered 4.1mm Width Increasing Drill 2 x 21mm CGS Pilot Drill Plastic Sleeve, Passive Fit Coping Tapered 5.8mm Bone Tap Tapered 4.7mm Width Increasing Drill 3.4mm Width Increasing Drill Internal 4.5 Implant Analog Tapered 4.6mm Crestal Bone Drill 2.5mm Tapered Depth Drill, 7.5mm Stop 2.5mm Tapered Depth Drill, 10.5mm Stop 5.8mm Tapered Depth Gauge Tapered 3.2mm Width Incr.Drill, Ext Shank Discontinued - Internal 3.5 Implant Analog Tapered 3.8mm Bone Tap Internal/Single-stage Direct Coping Screw, Shallow Hex Tapered 4.1mm Width Incr.Drill, Ext Shank 2.5 x 10.5mm Depth Drill 2.5mm x 9mm Depth Drill 3.9mm Width Increasing Drill Tapered 2.5mm Drill 2.5 x 12mm Depth Drill - Extended Shank Internal 5.7 Cover Cap Single-stage Implant Analog, 4.5mm 2.5 x 15mm Depth Drill - Extended Shank Discontinued - Internal 5.7 Implant Analog Single-stage Implant Analog, 5.7mm Single-stage Implant Analog, 3.5mm Tapered 3.2mm Width Increasing Drill 2 x 28mm CGS Pilot Drill 3mm Width Increasing Drill Tapered 2mm Starter Drill 2.5mm Surgical Depth Drill 4.6mm Tapered Depth Gauge 2.5mm Tapered Depth Drill, 9mm Stop 2.5mm Depth Drill, Extended Shank Internal 3.5 Implant Analog Drill Extender Starter Drill Ratchet External 4mm Angled Abutment, Hexed External 3.5mm Angled Abutment, Hexed Discontinued - Supersede to PXABCC - Cover Cap, AFS OP/OD Alignment Drill Internal 4.5 Cover Cap Internal 5.7 Cover Cap Discontinued - 3.5mm 3inOne Abut Regular Emergence, Mach'd Custom Temporary Abutment Sleeve Internal 3.5 Cover Cap Discontinued - 3.5mm Regular Emergence Angled Abutment, Machined Internal 5.7mm Regular Emergence Angled Abutment Discontinued - 4.5mm Cover Cap, Machined 3.5mm Custom Temporary Abutment, 3mm Height BioHorizons Internal Implant Discontinued - 5.7mm Cover Cap, Machined Discontinued - 5.7MM 3INONE ABUTMENT Internal 5.7 Regular Emergence 3inOne Abutment Internal 4.5mm Regular Emergence Angled Abutment Internal 3.5 Regular Emergence 3inOne Abutment Discontinued - 4.5mm Regular Emergence Angled Abutment, Machined Discontinued - 3.5mm Cover Cap, Machined Internal/Single-stage Abutment Screw 4.5mm Custom Temporary Abutment, 1mm Height Internal 4.5 Regular Emergence 3inOne Abutment Discontinued - 5.7mm Regular Emergence Angled Abutment, Machined 3.5mm Custom Temporary Abutment, 1mm Height Internal 3.5mm Regular Emergence Angled Abutment Discontinued - 4.5MM 3INONE ABUTMENT 4.5mm Custom Temporary Abutment, 3mm Height BioHorizons CAD/CAM Abutments O-RING ABUTMENT Intra-Lock Dental Implants with Blossom 3.4mm Implant Angled Abutment

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2013-02-01
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2013-02-01
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2013-02-01
DZL Screw, Fixation, Intraosseous Dental Class 2 872.4880 2021-07-01
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2013-01-23
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2012-11-07
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2015-03-10
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2021-07-01
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2013-02-01
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2013-02-01
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2019-04-30
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2019-04-30
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2019-04-30
DZL Screw, Fixation, Intraosseous Dental Class 2 872.4880 2013-02-01
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2013-01-23
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2019-04-30
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2019-04-30
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2019-04-30
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2021-07-01
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2021-07-01
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2013-02-01
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2013-02-01
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2013-02-01
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2013-01-23
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2021-07-01
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2021-07-01
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2013-02-01
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2021-07-01
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2021-07-01
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2013-01-23
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2019-04-30
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2019-04-30
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 2013-02-01
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2013-02-01
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2021-07-01
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2013-02-01
NDP Accessories, Implant, Dental, Endosseous Dental Class 1 872.3980 2013-02-04
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2013-02-01
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2013-02-01
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2013-02-01
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2013-02-01
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2021-07-01
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2021-07-01
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2019-04-30
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2019-04-30

Official Correspondent

Amose Kim

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Precision One Medical
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3017980266 Precision One Medical Hoover, AL, US

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 3009201148. Last updated year: 2026. Please use registration number 3009201148 when referencing this establishment in official correspondence.
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