# K031494: Doc's Best White Copper Cement

- Pathway: 510(k) (Traditional)
- Applicant: Cooley & Cooley, Ltd.
- Decided: Nov 12, 2003 after 183 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: 4 generations back to K900510 (1990). 13 ancestors in all.
No later device cites it as a predicate yet.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K933139: 3M Vitremer Luting Cement, 3M Company (1994) Summary page 1.
- K022476: Relyx Rmgip, 3M Company (2002) Summary page 1.
- K020256: Unicem, 3M Espe AG Dental Products (2002) Summary page 1.
- K895487: Temporary Dental Cement, Dentsply Intl. (1990) Summary page 1.
- (no number) Doc's Best Red Copper Cement: named in the summary without a submission number

## Indications for use
The Doc's Best White Copper Cement is a dental cement system for use in: 1. Luting porcelain to metal crowns and bridges to tooth structure, amalgam, composite or glass isomer core building; 2. Luting metal inlays, on lays or crowns; 3. Luting pre-fabricated and cast posts; 4. Luting orthodontic appliances; 5. Cavity liners; 6. Primary teeth cavity fillings

Source page: https://510kreport.com/device/K031494
Methodology: https://510kreport.com/methodology