Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1060818

FEI Number

1000592496

Entity Name

BIOHORIZONS IMPLANT SYSTEMS INC.

City/State/Country

BIRMINGHAM, AL, US

Establishment Address

2300 RIVERCHASE CENTER, BIRMINGHAM, AL 35244, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

BIOHORIZONS IMPLANT SYSTEMS, INC. (Owner Number: 9024113)

Owner / Operator Contact Address

2300 RIVERCHASE CENTER, --, Birmingham, AL 35244, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K080598

PMA Number

N/A

All Registered Proprietary Names

BioHorizons Tapered Internal Implant System Tapered Pro Conical Implant System BIOHORIZONS DENTAL IMPLANT ACCESSORIES Biolok Micro-Lok Implant System BioHorizons Simple Solutions with Laser-Lok BioHorizons Abutments for Zimmer Intra-Lock Dental Implants The Autotac System The Autotac System BioHorizons Dental Implant System BioHorizons Tapered Internal Plus Implants Mini Drive-Lock Dental Implant System Intra-Lock Dental Implants with Blossom Intra-Lock Angled Prosthetic Abutments ACE BONE SCREW TACKING KIT Milo Dental Implant System BioHorizons Tapered Internal Implants The Maestro System BioHorizons Laser-Lok 3 Implant System Tapered IM Implants BioHorizons Plastic Temporary Abutments SmartShape Healing Abutment; Wide Custom Milled Ti-Blank Abutment Conical Ti Base Abutments Intra-Lock Endosseous Implants MRI compatibility for existing BioHorizons dental implants and abutments Maestro System BioHorizons Single-stage Implant System BioHorizons Internal Implant System Intra-Lock Dental Implants with Blossom 3.4mm Implant Angled Abutments BioHorizons Single-stage Implant Multi-unit Abutments for CONELOG BIOHORIZONS COMFORT CAP BioHorizons CAD/CAM Abutments BioHorizons Tapered Short Implants BioHorizons Dental Implant System Mini Drive-Lock Dental Implant System Prosthetics

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	2016-10-26
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2016-10-26
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2024-06-06
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2024-06-06
NDP	Accessories, Implant, Dental, Endosseous	Dental	Class 1	872.3980	2009-12-01
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2016-10-26
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2016-10-26
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2016-10-26
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2019-07-17
DZL	Screw, Fixation, Intraosseous	Dental	Class 2	872.4880	2001-10-04
DZL	Screw, Fixation, Intraosseous	Dental	Class 2	872.4880	2016-10-26
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	1996-02-08
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2016-10-26
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2019-07-17
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2019-07-17
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2019-07-17
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2019-07-17
DZL	Screw, Fixation, Intraosseous	Dental	Class 2	872.4880	2025-11-25
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2019-07-17
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2019-07-17
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2016-10-26
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2016-10-26
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2016-10-26
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2016-10-26
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2018-11-20
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2016-10-26
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2024-08-07
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2025-05-06
PNP	Dental Abutment Design Software For Dental Laboratory	Dental	Class 2	872.3630	2025-05-06
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2019-07-17
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2019-07-17
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2023-10-24
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2023-10-24
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2016-10-26
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2016-10-27
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2016-10-27
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2019-07-17
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2016-10-26
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2021-04-16
ELZ	Crown, Preformed	Dental	Class 1	872.3330	2005-09-14
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2016-10-26
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2017-11-22
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2016-10-26
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2019-07-17

Official Correspondent

Jared Cooper

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

BIOHORIZONS IMPLANT SYSTEMS, INC.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

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 1060818. Last updated year: 2026. Please use registration number 1060818 when referencing this establishment in official correspondence.