BIOHORIZONS TAPERED INTERNAL IMPLANT SYSTEM— 510(k) K071638
Substantially EquivalentBioHorizons Implant Systems, Inc.
FDA 510(k) clearance K071638 for BIOHORIZONS TAPERED INTERNAL IMPLANT SYSTEM, Substantially Equivalent on 2007-10-10. Applicant: BioHorizons Implant Systems, Inc.. Device class: 2.
Clearance details
- Applicant
- BioHorizons Implant Systems, Inc.
- Product code
- Code DZE
- Device class
- Class 2
- Regulation
- 21 CFR 872.3640
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Diego, CA, US
Recent devices under product code DZE
view allMore clearances from BioHorizons Implant Systems, Inc.
view allAdverse events under product code DZE
product code DZE- Death
- 28
- Injury
- 3,367,041
- Malfunction
- 19,958
- Other
- 13
- Total
- 3,387,040
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 →
Recalls naming K071638
K-number listed on FDA's recall record- Z-1111-2025 — Temporary Titanium Abutments
- 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
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K071638.
Data sourced from openFDA. This site is unofficial and independent of the FDA.