Precision One Medical

FDA Device Registration & Listing · Hoover, AL, US · Registration 3017980266

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
3017980266
FEI Number
3017980266
Entity Name
Precision One Medical
City/State/Country
Hoover, AL, US
Establishment Address
2100 Riverchase Ctr Ste 106, Hoover, AL 35244, 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

2413001 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 Intra-Lock International Angled Prosthetic Abutments THE MAESTRO SYSTEM BIOHORIZONS SINGLE-STAGE 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 BioHorizons Tapered Short Implants 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 OP/OD Alignment Drill MODIFICATION TO THE MAESTRO SYSTEM 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 Intra-Lock MILO Implant System; Intra-Lock Angled Prosthetic Abutments BioHorizons Tapered Internal Implants Intra-Lock System Abutments; Intra-Lock Dental Implants Healing Abutment Drill Extension Shaft BIOHORIZONS DENTAL IMPLANT SYSTEM Temporary Abutment BIOHORIZONS INTERNAL IMPLANT SYSTEM Intra-Lock Mini Drive-Lock Dental Implant System Prostheses 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 THE AUTOTAC SYSTEM TITANIUM TACK 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 Internal/Single-stage Abutment Screw 511401 441802 406801 511501 563601 563701 406002 407502 BIOHORIZONS SIMPLE SOLUTIONS WITH LASER-LOK Multi-Unit Abutments For CONELOG Intra-Lock Dental Implants with Blossom 3.4mm Implant Angled Abutment Intra-Lock Mini Drive-Lock Dental Implant System Single-stage 3.5mm Angled Abutment Single-stage 5.7mm Angled Abutment BioHorizons Single-stage Implant Single-stage 4.5mm Angled Abutment 2542401 2411702 2411701 Screw Removal Kit NobRpl 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 BioHorizons CAD/CAM Abutments Drill Extender Starter Drill Ratchet External 4mm Angled Abutment, Hexed External 3.5mm Angled Abutment, Hexed Discontinued - Supersede to PXABCC - Cover Cap, AFS BIOHORIZONS TAPERED INTERNAL PLUS IMPLANTS 2542602 2543001 2542601 2542603 2542502 2542903 2543101 2542702 2543002 2542901 2542701 2542902 2542801 2542802 2543102 2542501 MODIFICATION TO THE MAESTRO 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 2798301 O-RING 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 2013-01-23
NDP Accessories, Implant, Dental, Endosseous Dental Class 1 872.3980 2013-02-04
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 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
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
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
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
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 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 2015-03-10
DZL Screw, Fixation, Intraosseous Dental Class 2 872.4880 2013-02-01
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2012-11-07
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
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2015-03-10
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 2013-02-01
DZL Screw, Fixation, Intraosseous Dental Class 2 872.4880 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 2013-01-23
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2013-02-01
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2021-07-01
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 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
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 2012-11-07
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
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 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
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 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 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 2021-07-01

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
3009201148 PRECISION ONE MEDICAL Oceanside, CA, 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-0013-2022 Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel 1
Scan Abutment SP, Cat. No. 30-70101 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function.
Z-0014-2022 Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel 1
Scan Abutment NP, Cat. No. 30-70102 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function.
Z-0015-2022 Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel 1
Scan Abutment MU, Cat. No. 30-70103 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function.
Z-0016-2022 Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel 1
Scan Abutment SU, Cat. No. 30-70104 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3017980266. Last updated year: 2026. Please use registration number 3017980266 when referencing this establishment in official correspondence.
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