Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 2 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list BioHorizons Implant Systems with 41 510(k) clearances and 5 device recalls. The most recent is a 510(k) clearance dated Jun 26, 2026: BioHorizons CEREC Compatible Ti-Bases.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Jun 26, 2026 | BioHorizons CEREC Compatible Ti-BasesK260061 · NHA | 510(k) clearances |
| May 1, 2025 | Conical Ti Base abutmentsK243521 · NHA | 510(k) clearances |
| Jul 30, 2024 | SmartShape™ Healing Abutment; Wide Custom Milled Ti-Blank AbutmentK240531 · NHA | 510(k) clearances |
| Jun 5, 2024 | Tapered Pro Conical Implant SystemK240187 · DZE | 510(k) clearances |
| Oct 13, 2023 | MRI compatibility for existing BioHorizons dental implants and abutmentsK223697 · DZE | 510(k) clearances |
| Mar 16, 2021 | Multi-unit Abutments for CONELOGK203252 · NHA | 510(k) clearances |
| Oct 10, 2018 | BioHorizons Tapered IM ImplantsK182070 · DZE | 510(k) clearances |
| Sep 28, 2018 | BioHorizons CAD/CAM BarsK180998 · NHA | 510(k) clearances |
| Oct 30, 2015 | RBT, Internal Implant, Laser-Lok, 5.0 x 15mm, 5.7 Platform, REF LPBR5015, Rx only, Sterile R, BIOHORIZONS(R), Dental ImplantClass II · An incorrect label reading 10.5mm and not the specified 15mm was placed on the implant inner vial packaging. | Device recalls |
| Apr 16, 2015 | Tapered HD Upgrade Set, REF TSKHDUS, Non-Sterile, Rx Only, Product Usage Usage: Surgical instruments used in preparation for dental iClass II · BioHorizons Tapered HD Upgrade set was packaged with an incorrect drill component manufactured of stainless steel in pla | Device recalls |
| Dec 10, 2013 | External Implant RBT, D3 Threadform 4.0 X 10.5mm, REF 40105D3, STERILE R, Rx Only, BioHorizons(R), 2300 Riverchase Center, Birmingham, AL Class II · The body length of the External Implant 40105D3 Lot 1302762 labeled as 10.5mm in length is in fact 12mm in length. | Device recalls |
| Nov 19, 2012 | AutoTac Delivery Handle, REF 400-200, Rx Only, non-sterile, BIOHORIZONS, BIRMINGHAM, AL 35244. Dental.Class II · The cleaning instructions provided may not be sufficient to remove residual contaminants after surgical use. | Device recalls |
| Nov 19, 2012 | Titanium Tack Starter Kit, REF 400-270, Rx Only, non-sterile, BIOHORIZONS, BIRMINGHAM, AL 35244. Dental.Class II · The cleaning instructions provided may not be sufficient to remove residual contaminants after surgical use. | Device recalls |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
