Prevest Denpro Cavity Liners (Apacal ART, Cal LC, Calcigel, CalUltra)— 510(k) K212475
Substantially EquivalentPrevest Denpro Limited
FDA 510(k) clearance K212475 for Prevest Denpro Cavity Liners (Apacal ART, Cal LC, Calcigel, CalUltra), Substantially Equivalent on 2022-05-13. Applicant: Prevest Denpro Limited. Device class: 2.
Clearance details
- Applicant
- Prevest Denpro Limited
- Product code
- Code EJK
- Device class
- Class 2
- Regulation
- 21 CFR 872.3250
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Bari Brahmana, IN
Recent devices under product code EJK
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Data sourced from openFDA. This site is unofficial and independent of the FDA.