ANTHOFIT OI, ANTHOFIT HE, OSSFIT AND AXIOM— 510(k) K101913
Substantially EquivalentAnthogyr Sas
FDA 510(k) clearance K101913 for ANTHOFIT OI, ANTHOFIT HE, OSSFIT AND AXIOM, Substantially Equivalent on 2011-03-11. Applicant: Anthogyr Sas. Device class: 2.
Clearance details
- Applicant
- Anthogyr Sas
- 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
- Abbreviated
- Location
- Sallanches, FR
Recent devices under product code DZE
view allMore clearances from Anthogyr Sas
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 K101913
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 K101913.
Data sourced from openFDA. This site is unofficial and independent of the FDA.