# K961291: Finesse Low-Fusing Porcelain System Auxiliary Products

- Pathway: 510(k) (Traditional)
- Applicant: Dentsply Intl.
- Decided: May 28, 1996 after 54 days
- Product code: EIH (Powder, Porcelain)
- Device class: 2
- Regulation: 21 CFR 872.6660
- 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 K954761 (1995). 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)
- K954761: Finesse Low-Fusing Porcelain System, Dentsply Intl. (1995) Summary page 1.

## Indications for use
The FINESSE™ LOW-FUSING PORCELAIN SYSTEM AUXILIARY PRODUCTS are for use with the Finesse™ Low-Fusing Porcelain System in conjunction with non-precious or noble or high noble alloys when used for conventional porcelain-fused-to-metal crowns, bridges or dental prostheses.

Source page: https://510kreport.com/device/K961291
Methodology: https://510kreport.com/methodology