# K993249: Opc Low Wear Opaque Porcelain

- Pathway: 510(k) (Traditional)
- Applicant: Jeneric/Pentron, Inc.
- Decided: Nov 29, 1999 after 62 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 K910303 (1991). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K982377: Opc Lowwear Porcelain, Jeneric/Pentron, Inc. (1998) Summary page 1.
- K910303: Sysnpar Porcelain, Jeneric/Pentron, Inc. (1991) Summary page 1.

## Indications for use
OPC Low Wear Opaque Porcelain is a porcelain powder, which will be bonded to metal copings to form dental restorations. Subsequent layers of translucent porcelains will be fired on top to complete the restoration. Particularly, to be used with OPC Low Wear Porcelain, K982377 to cover the metal restoration.

Source page: https://510kreport.com/device/K993249
Methodology: https://510kreport.com/methodology