ENDOFORM DENTAL TEMPLATE— 510(k) K101546
Substantially EquivalentMesynthes, Ltd.
FDA 510(k) clearance K101546 for ENDOFORM DENTAL TEMPLATE, Substantially Equivalent on 2010-06-23. Applicant: Mesynthes, Ltd..
Clearance details
- Applicant
- Mesynthes, Ltd.
- Product code
- Code KGN
- Advisory panel
- Unknown
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- North Attleboro, MA, US
Adverse events under product code KGN
product code KGN- Other
- 2
- Total
- 2
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.