# K082700: Temporary Cold.V and Self-Cure Dentine

- Pathway: 510(k) (Abbreviated)
- Applicant: Major Prodotti Dentari S.P.A.
- Decided: Dec 9, 2008 after 85 days
- Product code: EBG (Crown And Bridge, Temporary, Resin)
- Device class: 2
- Regulation: 21 CFR 872.3770
- 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 K961199 (1996). 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)
- K961199: Bosworth Temporary Resin, Harry J. Bosworth Co. (1996) Summary page 1.

## Indications for use
temporary.cold.v and self-cure dentine are temporary cold-curing indirect crowns & bridges materials. Poly-methylmethacrylate based. Powder and liquid. Intended use: - Construction of temporary crowns and bridges - Immediate crown brush-modeling - For gypsum or silicone key pouring technique - For rapidly repairing acrylic crowns and bridges

Source page: https://510kreport.com/device/K082700
Methodology: https://510kreport.com/methodology