FDA Registration
Active
🇺🇸 United States
PRECISION ONE MEDICAL
Reg #: 3009201148
·
FEI: 3009201148
·
Expires 2026
Products
7
Proprietary Names
253
Establishment Types
1
Classifications
7
Registration Details
- Registration Name
- PRECISION ONE MEDICAL
- Registration Number
- 3009201148
- FEI Number
- 3009201148
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 3923 OCEANIC DR STE 200
- City
- Oceanside
- State
- CA
- ZIP
- 92056
- Country
- US
Owner / Operator
- Firm Name
- Precision One Medical
- Operator Number
- 10042281
- Address
- 3923 Oceanic Dr., Suite 200
- City
- Oceanside
- State
- CA
- Postal Code
- 92056
- Country
- US
- Correspondent
- Amose Kim
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Abutment, Implant, Dental, Endosseous | NHA | Class 2 | Dental | No | 2013-02-01 |
| Implant, Endosseous, Root-Form | DZE | Class 2 | Dental | No | 2013-02-01 |
| Screw, Fixation, Intraosseous | DZL | Class 2 | Dental | No | 2021-07-01 |
| Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | KTT | Class 2 | Orthopedic | No | 2013-02-01 |
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2013-02-01 |
| Accessories, Implant, Dental, Endosseous | NDP | Class 1 | Dental | No | 2013-02-04 |
| Plate, Fixation, Bone | HRS | Class 2 | Orthopedic | No | 2013-02-01 |
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
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
5.7mm 20 Degree Angled Abutment (Regular Emergence)
4.5mm Dual Purpose Abutment (Regular Emergence)
Internal 4.5mm Straight Esthetic Abutment, Laser-Lok
4.5mm 20 Degree Angled Abutment (Regular Emergence)
3.5mm 20 Degree Angled Abutment (Regular Emergence)
Internal 3.5mm Straight Esthetic Abutment, 3mm Buccal, Laser-Lok
Internal 5.7mm Angled Esthetic Abutment, Laser-Lok
BioHorizons Tapered Internal Implant
Internal 3.5mm Straight Esthetic Abutment, Laser-Lok
5.7mm Dual Purpose Abutment (Regular Emergence)
Internal 4.5mm Angled Esthetic Abutment, Laser-Lok
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
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
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
Custom Temporary Abutment Sleeve
Internal 3.5 Cover Cap
Discontinued - 4.5mm Cover Cap, Machined
3.5mm Custom Temporary Abutment, 3mm Height
BioHorizons Internal Implant
Discontinued - 5.7mm Cover Cap, Machined
Discontinued - 3.5mm Cover Cap, Machined
4.5mm Custom Temporary Abutment, 1mm Height
3.5mm Custom Temporary Abutment, 1mm Height
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
2798301
Intra-Lock Mini Drive-Lock Dental Implant System Prostheses
Single-stage 3.5mm Angled Abutment
Single-stage 5.7mm Angled Abutment
BioHorizons Single-stage Implant
Single-stage 4.5mm Angled Abutment
Temporary Abutment
BIOHORIZONS SINGLE-STAGE IMPLANT SYSTEM
Drill Extension Shaft
BioHorizons Tapered Internal Implants
BIOHORIZONS SIMPLE SOLUTIONS WITH LASER-LOK
Multi-Unit Abutments For CONELOG
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)