# K994435: Opc 3G All-Ceramic System, Core and Overlay Porcelains

- Pathway: 510(k) (Traditional)
- Applicant: Jeneric/Pentron, Inc.
- Decided: Feb 10, 2000 after 42 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: 2 generations back to K830955 (1983). 3 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K971869: Finesse All-Ceramic System, Dentsply Intl. (1997) Summary page 1.
- K982616: Ips Empress 2, Ivoclar North America, Inc. (1998) Summary page 1.
- (no number) Finesse Porcelain: named in the summary without a submission number
- (no number) Empress2 Porcelain: named in the summary without a submission number

## Most influential descendants
- K141400: Dcceram System (2015), 3 descendants of its own
- K192251: Livento Press, Soprano 10, Soprano (2020), 1 descendant of its own
- K251084: zirkon; structure; LFU shades, stains and glazes (2025), 0 descendants of its own
- K163228: APVolution System (2017), 0 descendants of its own
- K063842: Cyrtina System (2007), 0 descendants of its own

## Indications for use
The OPC 3G All-Ceramic System, Core and Overlay Porcelains comprise a lithium disilicate glass-ceramic core used for all-ceramic dental restorations. Subsequent layers of porcelain are applied over top to provide additional aesthetics and characterizations. This system offers high strength, low wear, the aesthetics of a metal-free system, and better thermal shock properties due to the lower thermal expansion of the materials used. The dental restoration is prepared by a lost wax technique. The dental restorations are designed in a wax pattern and invested into refractory. The refractory is burned out to remove the wax and leave a cavity of the dental design. Pellets of 3G All-Ceramic are placed into the investment cavity and transferred to a hot pressing furnace where the investment/pellets are brought to a higher temperature. The temperature is maintained long enough for the glass-ceramic to become molten and then pressed into the cavity creating an exact duplicate of the original wax pattern. In addition, dental restorations can be made by forming the material into pre made blocks of ceramics, which are milled to the coping/bridge shape by CAD/CAM equipment. The OPC 3G All-Ceramic System, Core and Overlay Porcelains are intended for either hot pressing or CAD/CAM machining all-ceramic dental restorations. The OPC 3G All-Ceramic System, Core and Overlay Porcelains should be used with 3G All-Ceramic materials only and not intermixed with other manufacturers products/porcelains. The system is used for fabrication of dental restorations including inlays, onlays, veneers, single units, and anterior

Source page: https://510kreport.com/device/K994435
Methodology: https://510kreport.com/methodology