Manufacturer registered with FDA
Precision One Medical
Oceanside, CA, United States. Lists 4 dental device types with FDA across 2 registered establishments.
- Device types listed
- 4
- Brands and models
- 318
- 510(k) clearances
- 0as applicant
- Markets registered in
- 1United States
- Establishments
- 2United States
Devices listed with FDA
What Precision One Medical currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Root-Form Endosseous ImplantDZE · Class 2 | Dental implants | Maker | BIOHORIZONS DENTAL IMPLANT SYSTEMBioHorizons Internal ImplantBIOHORIZONS INTERNAL IMPLANT SYSTEMBioHorizons Single-stage ImplantBIOHORIZONS SINGLE-STAGE IMPLANT SYSTEMBioHorizons Tapered IM ImplantsBioHorizons Tapered Internal ImplantBioHorizons Tapered Internal ImplantsBIOHORIZONS TAPERED INTERNAL PLUS IMPLANTSBioHorizons Tapered Short Implants 109 moreCustom Temporary Abutment SleeveDiscontinued - 3 Straight Esthetic Abutment, 3mm BuccalDiscontinued - 3.5mm 3inOne Abut Regular Emergence, Mach'dDiscontinued - 3.5mm Cover Cap, MachinedDiscontinued - 3.5mm Internal Angled Esthetic Abutment, MachinedDiscontinued - 3.5mm Internal Straight Esthetic Abutment, MachinedDiscontinued - 3.5mm Regular Emergence Angled Abutment, MachinedDiscontinued - 3mm Angled Esthetic AbutmentDiscontinued - 4.5MM 3INONE ABUTMENTDiscontinued - 4.5mm Cover Cap, MachinedDiscontinued - 4.5mm Internal Angled Esthetic Abutment, MachinedDiscontinued - 4.5mm Internal Straight Esthetic AbutmentDiscontinued - 4.5mm Regular Emergence Angled Abutment, MachinedDiscontinued - 5.7MM 3INONE ABUTMENTDiscontinued - 5.7mm Cover Cap, MachinedDiscontinued - 5.7mm Internal Angled Esthetic AbutmentDiscontinued - 5.7mm Internal Straight Esthetic Abutment, MachinedDiscontinued - 5.7mm Regular Emergence Angled Abutment, MachinedDiscontinued - Internal 3.5mm Straight Esthetic Abutment, 3mm Margin MachinedDiscontinued - Internal 4.5mm Straight Esthetic Abutment, 3mm Margin MachinedDiscontinued - Internal 5.7mm Straight Esthetic Abutment, 3mm Margin MachinedDiscontinued - Supersede to PXABCC - Cover Cap, AFSDiscontinued - Two-piece 3 Straight Esthetic AbutmentDrill ExtenderDrill Extension ShaftExternal 3.5mm Abutment for Screw, 3.5mm CollarExternal 3.5mm Angled Abutment, HexedExternal 4mm Angled Abutment, HexedExternal 5mm Abutment for Screw, 3.5mm CollarHealing AbutmentInternal 3.5 Cover CapInternal 3.5 Regular Emergence 3inOne AbutmentInternal 3.5mm Angled Esthetic AbutmentInternal 3.5mm Angled Esthetic Abutment, Laser-LokInternal 3.5mm Regular Emergence Angled AbutmentInternal 3.5mm Straight Esthetic AbutmentInternal 3.5mm Straight Esthetic Abutment, 3mm BuccalInternal 3.5mm Straight Esthetic Abutment, 3mm Buccal, Laser-LokInternal 3.5mm Straight Esthetic Abutment, Laser-LokInternal 4.5 Cover CapInternal 4.5 Regular Emergence 3inOne AbutmentInternal 4.5mm Angled Esthetic AbutmentInternal 4.5mm Angled Esthetic Abutment, Laser-LokInternal 4.5mm Regular Emergence Angled AbutmentInternal 4.5mm Straight Esthetic AbutmentInternal 4.5mm Straight Esthetic Abutment, 3mm BuccalInternal 4.5mm Straight Esthetic Abutment, 3mm Buccal, Laser-LokInternal 4.5mm Straight Esthetic Abutment, Laser-LokInternal 5.7 Cover CapInternal 5.7 Regular Emergence 3inOne AbutmentInternal 5.7mm Angled Esthetic AbutmentInternal 5.7mm Angled Esthetic Abutment, Laser-LokInternal 5.7mm Regular Emergence Angled AbutmentInternal 5.7mm Straight Esthetic AbutmentInternal 5.7mm Straight Esthetic Abutment, 3mm BuccalInternal 5.7mm Straight Esthetic Abutment, 3mm Buccal, Laser-LokInternal 5.7mm Straight Esthetic Abutment, Laser-LokInternal/Single-stage Abutment ScrewIntra-Lock International Endossous Implant & Abutment SystemIntra-Lock MILO Implant System; Intra-Lock Angled Prosthetic AbutmentsIntra-Lock Mini Drive-Lock Dental Implant SystemIntra-Lock System Abutments; Intra-Lock Dental ImplantsMODIFICATION TO THE MAESTRO SYSTEMO-RING ABUTMENTOP/OD Alignment DrillRatchetScrew Removal Kit NobRplSingle-stage 3.5mm Angled AbutmentSingle-stage 4.5mm Angled AbutmentSingle-stage 5.7mm Angled AbutmentStarter DrillTHE MAESTRO SYSTEM2411701241170225424013.45mm Plastic Castable Abutment, Hexed3.45mm x 15 Degree Angled Abutment, Micro-Lok3.5mm 20 Degree Angled Abutment (Regular Emergence)3.5mm Custom Temporary Abutment, 1mm Height3.5mm Custom Temporary Abutment, 3mm Height3.5mm Dual Purpose Abutment (Regular Emergence)3mm Angled Esthetic Abutment3mm Angled Esthetic Abutment, Laser-Lok3mm Cover Cap3mm Crestal Bone Drill3mm Custom Temporary Abutment Sleeve3mm Straight Esthetic Abutment3mm Straight Esthetic Abutment, 3mm Buccal3mm Straight Esthetic Abutment, 3mm Buccal, Laser-Lok3mm Straight Esthetic Abutment, Laser-Lok3mm Two-piece Custom Temporary Abutment, 1mm Height3mm Two-piece Custom Temporary Abutment, 3mm Height4.5mm 20 Degree Angled Abutment (Regular Emergence)4.5mm Custom Temporary Abutment, 1mm Height4.5mm Custom Temporary Abutment, 3mm Height4.5mm Dual Purpose Abutment (Regular Emergence)4060024068014075024418024mm Plastic Castable Abutment, Non-hexed4mm x 15 Degree Angled Abutment, Micro-Lok4mm x 25 Degree Angled Abutment, Micro-Lok5.7mm 20 Degree Angled Abutment (Regular Emergence)5.7mm Dual Purpose Abutment (Regular Emergence)511401511501563601563701 | 2012 |
| Endosseous Dental Implant AbutmentNHA · Class 2 | Implant abutments | Maker | Abutment Screw, Multi-unit AbutmentBioHorizons CAD/CAM AbutmentsBIOHORIZONS SIMPLE SOLUTIONS WITH LASER-LOKBioHorizons Tapered Internal ImplantDiscontinued - 3 Straight Esthetic Abutment, 3mm BuccalDiscontinued - 3.5mm 3inOne Abut Regular Emergence, Mach'dDiscontinued - 3.5mm Internal Angled Esthetic Abutment, MachinedDiscontinued - 3.5mm Internal Straight Esthetic Abutment, MachinedDiscontinued - 3.5mm Regular Emergence Angled Abutment, MachinedDiscontinued - 3.5mm Ti-N Angled Esthetic Abutment, Machined 131 moreDiscontinued - 3mm Angled Esthetic AbutmentDiscontinued - 4.5MM 3INONE ABUTMENTDiscontinued - 4.5mm Internal Angled Esthetic Abutment, MachinedDiscontinued - 4.5mm Internal Straight Esthetic AbutmentDiscontinued - 4.5mm Regular Emergence Angled Abutment, MachinedDiscontinued - 4mm Ti-N Angled Esthetic Abutment, MachinedDiscontinued - 5.7MM 3INONE ABUTMENTDiscontinued - 5.7mm Internal Angled Esthetic AbutmentDiscontinued - 5.7mm Internal Straight Esthetic Abutment, MachinedDiscontinued - 5.7mm Regular Emergence Angled Abutment, MachinedDiscontinued - Internal 3.5mm Straight Esthetic Abutment, 3mm Margin MachinedDiscontinued - Internal 4.5mm Straight Esthetic Abutment, 3mm Margin MachinedDiscontinued - Internal 5.7mm Straight Esthetic Abutment, 3mm Margin MachinedDiscontinued - Two-piece 3 Straight Esthetic AbutmentExternal 3.5mm 3inOne Abutment, HexedExternal 3.5mm Angled Esthetic Abutment, HexedExternal 4mm 3inOne Abutment, HexedExternal 4mm Angled Esthetic Abutment, HexedExternal 5mm 3inOne Abutment, HexedExternal 5mm Angled Esthetic Abutment, HexedExternal 6mm 3inOne Abutment, HexedInternal 3.5 Regular Emergence 3inOne AbutmentInternal 3.5mm Angled AFS, 17.5 DegreeInternal 3.5mm Angled Esthetic AbutmentInternal 3.5mm Angled Esthetic Abutment, Laser-LokInternal 3.5mm Laser-Lok Titanium Base AbutmentInternal 3.5mm Regular Emergence Angled AbutmentInternal 3.5mm Straight Esthetic AbutmentInternal 3.5mm Straight Esthetic Abutment, 3mm BuccalInternal 3.5mm Straight Esthetic Abutment, 3mm Buccal, Laser-LokInternal 3.5mm Straight Esthetic Abutment, Laser-LokInternal 4.5 Regular Emergence 3inOne AbutmentInternal 4.5mm Angled AFS, 15 DegreeInternal 4.5mm Angled AFS, 25 DegreeInternal 4.5mm Angled Esthetic AbutmentInternal 4.5mm Angled Esthetic Abutment, Laser-LokInternal 4.5mm Laser-Lok Titanium Base AbutmentInternal 4.5mm Regular Emergence Angled AbutmentInternal 4.5mm Straight Esthetic AbutmentInternal 4.5mm Straight Esthetic Abutment, 3mm BuccalInternal 4.5mm Straight Esthetic Abutment, 3mm Buccal, Laser-LokInternal 4.5mm Straight Esthetic Abutment, Laser-LokInternal 5.7 Regular Emergence 3inOne AbutmentInternal 5.7mm Angled Esthetic AbutmentInternal 5.7mm Angled Esthetic Abutment, Laser-LokInternal 5.7mm Laser-Lok Titanium Base AbutmentInternal 5.7mm Regular Emergence Angled AbutmentInternal 5.7mm Straight Esthetic AbutmentInternal 5.7mm Straight Esthetic Abutment, 3mm BuccalInternal 5.7mm Straight Esthetic Abutment, 3mm Buccal, Laser-LokInternal 5.7mm Straight Esthetic Abutment, Laser-LokInternal/Single-stage Abutment ScrewIntra-Lock Dental Implants with Blossom 3.4mm Implant Angled AbutmentIntra-Lock International Angled Prosthetic AbutmentsIntra-Lock International Endossous Implant & Abutment SystemIntra-Lock MILO Implant System; Intra-Lock Angled Prosthetic AbutmentsIntra-Lock Mini Drive-Lock Dental Implant System ProsthesesIntra-Lock System Abutments; Intra-Lock Dental ImplantsLaser-Lok Angled Esthetic Abutment for Nobel, NPLaser-Lok Angled Esthetic Abutment for Nobel, RPLaser-Lok Angled Esthetic Abutment for Nobel, WPLaser-Lok Straight Esthetic Abutment for Nobel, NPLaser-Lok Straight Esthetic Abutment for Nobel, NP, 3mm BuccalLaser-Lok Straight Esthetic Abutment for Nobel, RPLaser-Lok Straight Esthetic Abutment for Nobel, RP, 3mm BuccalLaser-Lok Straight Esthetic Abutment for Nobel, WPLaser-Lok Straight Esthetic Abutment for Nobel, WP, 3mm BuccalMulti-Unit Abutments For CONELOGNP Tri-Channel Abutment Screw for NobelPlastic Coping, Multi-unitProsthetic Screw, Multi-unit, Long (pack of 5)Prosthetic Screw, Multi-unit, Regular (pack of 5)RP/WP Tri-Channel Abutment Screw for NobelTemporary Abutment2413001254250125425022542601254260225426032542701254270225428012542802254290125429022542903254300125430022543101254310227983013.5mm 20 Degree Angled Abutment (Regular Emergence)3.5mm Dual Purpose Abutment (Regular Emergence)3.5mm Multi-unit Abutment, 17-degree, 2.25mm Collar3.5mm Multi-unit Abutment, 17-degree, 3mm Collar3.5mm Multi-unit Abutment, 30-degree, 4mm Collar3.5mm Multi-unit Abutment, 30-degree, 5mm Collar3.5mm Multi-unit Abutment, Straight 2mm Collar3.5mm Multi-unit Abutment, Straight 3mm Collar3.5mm Multi-unit Abutment, Straight 5mm Collar3mm Angled Esthetic Abutment3mm Angled Esthetic Abutment, Laser-Lok3mm Cover Cap3mm Crestal Bone Drill3mm Custom Temporary Abutment Sleeve3mm Multi-unit Abutment, 17-degree, 2.25mm Collar3mm Multi-unit Abutment, 17-degree, 3mm Collar3mm Straight Esthetic Abutment3mm Straight Esthetic Abutment, 3mm Buccal3mm Straight Esthetic Abutment, 3mm Buccal, Laser-Lok3mm Straight Esthetic Abutment, Laser-Lok3mm Two-piece Custom Temporary Abutment, 1mm Height3mm Two-piece Custom Temporary Abutment, 3mm Height4.5mm 20 Degree Angled Abutment (Regular Emergence)4.5mm Dual Purpose Abutment (Regular Emergence)4.5mm Multi-unit Abutment, 17-degree, 2.25mm Collar4.5mm Multi-unit Abutment, 17-degree, 3mm Collar4.5mm Multi-unit Abutment, 17-degree, 4mm Collar4.5mm Multi-unit Abutment, 30-degree, 3mm Collar4.5mm Multi-unit Abutment, 30-degree, 4mm Collar4.5mm Multi-unit Abutment, 30-degree, 5mm Collar4.5mm Multi-unit Abutment, Straight 1mm Collar4.5mm Multi-unit Abutment, Straight 2mm Collar4.5mm Multi-unit Abutment, Straight 3mm Collar4.5mm Multi-unit Abutment, Straight 4mm Collar4.5mm Multi-unit Abutment, Straight 5mm Collar5.7mm 20 Degree Angled Abutment (Regular Emergence)5.7mm Dual Purpose Abutment (Regular Emergence)5.7mm Multi-unit Abutment, Straight 1mm Collar5.7mm Multi-unit Abutment, Straight 2mm Collar | 2013 |
| Intraosseous Fixation ScrewDZL · Class 2 | Maxillofacial plates & screws | Maker | THE AUTOTAC SYSTEM TITANIUM TACK | 2013 |
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | Maker | Discontinued - Internal 3.5 Implant AnalogDiscontinued - Internal 4.5 Implant AnalogDiscontinued - Internal 5.7 Implant AnalogInternal 3.5 Implant AnalogInternal 4.5 Implant AnalogInternal 5.7 Cover CapInternal/Single-stage Direct Coping Screw, Shallow HexPlastic Sleeve, Passive Fit CopingSingle-stage Implant Analog, 3.5mmSingle-stage Implant Analog, 4.5mm 47 moreSingle-stage Implant Analog, 5.7mmTapered 2.5mm DrillTapered 2mm Starter DrillTapered 2mm Starter Drill, Ext ShankTapered 3 Depth GaugeTapered 3.2mm Width Incr.Drill, Ext ShankTapered 3.2mm Width Increasing DrillTapered 3.7mm Width Increasing DrillTapered 3.8mm Bone TapTapered 3.8mm Crestal Bone DrillTapered 4.1mm Width Incr.Drill, Ext ShankTapered 4.1mm Width Increasing DrillTapered 4.6mm Bone TapTapered 4.6mm Crestal Bone DrillTapered 4.7mm Width Increasing DrillTapered 5.4mm Width Incr.Drill, Ext ShankTapered 5.4mm Width Increasing DrillTapered 5.8mm Bone TapTapered 5.8mm Crestal Bone Drill2 x 17mm CGS Pilot Drill2 x 21mm CGS Pilot Drill2 x 24mm CGS Pilot Drill2 x 28mm CGS Pilot Drill2.5 x 10.5mm Depth Drill2.5 x 10.5mm Depth Drill - Extended Shank2.5 x 12mm Depth Drill2.5 x 12mm Depth Drill - Extended Shank2.5 x 15mm Depth Drill2.5 x 15mm Depth Drill - Extended Shank2.5mm Depth Drill, Extended Shank2.5mm Surgical Depth Drill2.5mm Tapered Depth Drill, 10.5mm Stop2.5mm Tapered Depth Drill, 12mm Stop2.5mm Tapered Depth Drill, 15mm Stop2.5mm Tapered Depth Drill, 7.5mm Stop2.5mm Tapered Depth Drill, 9mm Stop2.5mm x 9mm Depth Drill3.4mm Width Increasing Drill3.8mm Tapered Depth Gauge3.9mm Width Increasing Drill30 Degree Angled Parallel Pin3mm Width Increasing Drill4.4mm Width Increasing Drill4.6mm Tapered Depth Gauge4.9mm Width Increasing Drill5.4mm Width Increasing Drill5.8mm Tapered Depth Gauge | 2013 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| Precision One MedicalFDA reg. 3017980266 | Hoover, AL, United States | Contract manufacturer |
| PRECISION ONE MEDICALFDA reg. 3009201148 | Oceanside, CA, United States | Contract manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10042281). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.