# K982377: Opc Lowwear Porcelain

- Pathway: 510(k) (Traditional)
- Applicant: Jeneric/Pentron, Inc.
- Decided: Aug 18, 1998 after 41 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K993249: Opc Low Wear Opaque Porcelain (1999), 0 descendants of its own

## Indications for use
OPC LowWear™ Porcelain (enamel and incisal for mixing) is to be used in conjunction with Optimal Pressable Ceramic (OPC) pellets for all-ceramic fixed prosthodontics, inckluding full crowns, veneers and inlays/onlays. These translucent porcelains are applied in thin layers over the OPC pellet pressed ceramic cores. The average crystal size of the leucite within the LowWear Porcelain glassy matrix is 2-3 pm, with a crystal size range between 1-4 ym. The smaller leucite crystals vs. conventional porcelains and other all-ceramic porcelains (average 8 um, range 1-40 pm) resuits in less abrasion against opposing dentition, as supported by independent testing from Dr. Shiro Suzuki, University of Alabama at Birmingham.

Source page: https://510kreport.com/device/K982377
Methodology: https://510kreport.com/methodology