# K201937: Ceramir Restore QuikCap

- Pathway: 510(k) (Abbreviated)
- Applicant: Doxa Dental AB
- Decided: Nov 13, 2020 after 123 days
- Product code: EMA (Cement, Dental)
- Device class: 2
- Regulation: 21 CFR 872.3275
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K030516 (2003). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030516: Riva-Self Cure, Southern Dental Industries, Inc. (2003) Summary page 4.

## Indications for use
Non-load bearing Class I and II restorations Deciduous teeth restorations Geriatric restorations Intermediate restorative and base material for Class I and II cavities using the sandwich technique Cervical (Class V) restorations Core build ups Temporary fillings Dentin replacement

Source page: https://510kreport.com/device/K201937
Methodology: https://510kreport.com/methodology