BioHorizons CEREC Compatible Ti-Bases— 510(k) K260061
Substantially EquivalentBioHorizons Implant Systems, Inc.
FDA 510(k) clearance K260061 for BioHorizons CEREC Compatible Ti-Bases, Substantially Equivalent on 2026-06-26. Applicant: BioHorizons Implant Systems, Inc.. Device class: 2.
Summary
BioHorizons Implant Systems' CEREC Compatible Ti-Bases are filed under NHA, endosseous dental implant abutments. The CEREC compatibility is stated in the device name; the record doesn't list sizes or models.
Class II, 21 CFR 872.3630. Dental is both the classification panel and the review panel. It was a Traditional 510(k).
BioHorizons filed from Birmingham, Alabama. Review took 169 calendar days (January 8 to June 26, 2026).
Clearance details
- Applicant
- BioHorizons Implant Systems, Inc.
- Product code
- Product code NHA
- Device class
- Class 2
- Regulation
- 21 CFR 872.3630
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Birmingham, AL, US
Recent devices under product code NHA
view allMore clearances from BioHorizons Implant Systems, Inc.
view allAdverse events under product code NHA
product code NHA- Injury
- 1,270
- Malfunction
- 2,860
- Total
- 4,130
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.