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
Abutment, Implant, Dental, Endosseous NHA
Implant, Endosseous, Root-Form DZE
Screw, Fixation, Intraosseous DZL
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component KTT
Screw, Fixation, Bone HWC
Accessories, Implant, Dental, Endosseous NDP
Plate, Fixation, Bone HRS

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)