ASTRA TECH IMPLANTS-DENTAL SYSTEM— 510(k) K931767
Substantially EquivalentAstra Tech, Inc.
FDA 510(k) clearance K931767 for ASTRA TECH IMPLANTS-DENTAL SYSTEM, Substantially Equivalent on 1994-02-08. Applicant: Astra Tech, Inc.. Device class: 2.
Clearance details
- Applicant
- Astra Tech, 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
- Waltham, MA, US
Recent devices under product code DZE
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- K110356 — ATLANTIS CROWN ABUTMENT, ATLANTIS GEMINI +(TM) ABUTMENT
Adverse 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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.