THE AUTOTAC SYSTEM— 510(k) K993493
Substantially EquivalentBioHorizons Implant Systems, Inc.
FDA 510(k) clearance K993493 for THE AUTOTAC SYSTEM, Substantially Equivalent on 2000-01-07. Applicant: BioHorizons Implant Systems, Inc.. Device class: 2.
Clearance details
- Applicant
- BioHorizons Implant Systems, Inc.
- Product code
- Code DZL
- Device class
- Class 2
- Regulation
- 21 CFR 872.4880
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Birmingham, AL, US
Recent devices under product code DZL
view allMore clearances from BioHorizons Implant Systems, Inc.
view allAdverse events under product code DZL
product code DZL- Injury
- 168
- Total
- 168
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 K993493
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K993493.
Data sourced from openFDA. This site is unofficial and independent of the FDA.