BioHorizons Implant Systems, Inc.
BioHorizons Implant Systems, Inc. holds FDA 510(k) medical device clearances, first cleared 1996, most recent 2026, with 5 FDA device recalls on record.
Top product codes for BioHorizons Implant Systems, Inc.
FDA recalls by BioHorizons Implant Systems, Inc.
- Z-0391-2016 — RBT, Internal Implant, Laser-Lok, 5.0 x 15mm, 5.7 Platform, REF LPBR5015, Rx only, Sterile R, BIOHORIZONS(R), Dental Implant
- Z-1605-2015 — Tapered HD Upgrade Set, REF TSKHDUS, Non-Sterile, Rx Only, Product Usage Usage: Surgical instruments used in preparation for dental implant placement
- Z-1058-2014 — External Implant RBT, D3 Threadform 4.0 X 10.5mm, REF 40105D3, STERILE R, Rx Only, BioHorizons(R), 2300 Riverchase Center, Birmingham, AL 35244 Usage: dental
- Z-0561-2013 — AutoTac Delivery Handle, REF 400-200, Rx Only, non-sterile, BIOHORIZONS, BIRMINGHAM, AL 35244. Dental.
- Z-0562-2013 — Titanium Tack Starter Kit, REF 400-270, Rx Only, non-sterile, BIOHORIZONS, BIRMINGHAM, AL 35244. Dental.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by BioHorizons Implant Systems, Inc.
- K260061 — BioHorizons CEREC Compatible Ti-Bases
- K243521 — Conical Ti Base abutments
- K240531 — SmartShape Healing Abutment; Wide Custom Milled Ti-Blank Abutment
- K240187 — Tapered Pro Conical Implant System
- K223697 — MRI compatibility for existing BioHorizons dental implants and abutments
- K203252 — Multi-unit Abutments for CONELOG
- K182070 — BioHorizons Tapered IM Implants
- K180998 — BioHorizons CAD/CAM Bars
- K172576 — BioHorizons Tapered Short Implants
- K151621 — BioHorizons CAD/CAM Abutments
- K143022 — BioHorizons Tapered Internal Implants
- K121787 — BIOHORIZONS TAPERED INTERNAL PLUS IMPLANTS
- K103291 — BIOHORIZONS LASER-LOK ABUTMENTS FOR NOBEL BIOCARE
- K103691 — BIOHORIZONS ABUTMENTS FOR ZIMMER
- K100985 — BIOHORIZONS SIMPLE SOLUTIONS WITH LASER-LOK
- K093321 — BIOHORIZONS LASER-LOK 3.0 IMPLANT SYSTEM
- K081818 — BIOLOK MICRO-LOK IMPLANT SYSTEM
- K073282 — BIOHORIZONS SINGLE-STAGE IMPLANT SYSTEM
- K073268 — BIOHORIZONS INTERNAL IMPLANT SYSTEM
- K071638 — BIOHORIZONS TAPERED INTERNAL IMPLANT SYSTEM
- K061567 — BIOHORIZONS CERAMIC ABUTMENT
- K053099 — BIOHORIZONS PLASTIC TEMPORARY ABUTMENTS
- K053152 — BIOHORIZONS SINGLE-STAGE IMPLANT
- K052419 — MAXIMUS 3.0 AND OS IMPLANTS
- K042429 — THE PRODIGY SYSTEM DENTAL IMPLANTS
- K041938 — MAXIMUS OS (OVERDENTURE SYSTEM)
- K032351 — THE MAESTRO SYSTEM 3.0MM DIAMETER IMPLANT
- K030463 — MODIFICATION TO THE MAESTRO SYSTEM
- K022795 — MODIFICATION TO THE MAESTRO SYSTEM
- K022790 — THE AUTOTAC SYSTEM TITANIUM TACK
- K020645 — MODIFICATION TO THE MAESTRO SYSTEM
- K020133 — MODIFICATION TO THE MAESTRO SYSTEM
- K011675 — THE AUTOTAC SYSTEM
- K010458 — THE MAESTRO SYSTEM
- K993493 — THE AUTOTAC SYSTEM
- K990277 — O-RING ABUTMENT
- K980374 — IMPLANT SITE DILATORS
- K972313 — THE MAESTRO SYSTEM
- K964330 — BIOHORIZONS DENTAL IMPLANT SYSTEM (NAME SUBJECT TO CHANGE)
- K963951 — AS 123 PROSTHETIC INSTRUMENTATION SYSTEM
- K960026 — BIOHORIZONS DENTAL IMPLANT SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.