# K982692: Sternomega Bonding Agent, Sternomega Composite LC, Sternomega Compomer LC

- Pathway: 510(k) (Abbreviated)
- Applicant: Sterngold/Implamed
- Decided: Oct 22, 1998 after 80 days
- Product code: EBF (Material, Tooth Shade, Resin)
- Device class: 2
- Regulation: 21 CFR 872.3690
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K931812 (1993). 20 ancestors in all.
No later device cites it as a predicate yet.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K962348: Prime & Bond 2.1 Multipurpose Dentin/Enamel Bonding Agent, Dentsply Intl. (1996) Summary page 1.
- K940513: Optibond, Kerr Corporation (Danbury) (1994) Summary page 1.
- K964773: Dentemp One Step, Majestic Drug Co., Inc. (1997) Summary page 1.
- K973388: Dentin Conditioning and Adhesive (Bond 1), Jeneric/Pentron, Inc. (1997) Summary page 1.
- K844662: Kerr Herculite Dental Composite Restorative Materi, Kerr Corporation (Danbury) (1985) Summary page 1.
- K963805: Prodigy AC, Sybron Dental Specialties, Inc. (1996) Summary page 1.
- K921820: Renamel Esthetic Restorative System, Modification, Cosmedent, Inc. (1992) Summary page 1.
- K932013: Charisma -- Modified, Heraeus Kulzer, Inc. (1993) Summary page 1.
- K964285: Tetric Ceram, Ivoclar North America, Inc. (1997) Summary page 1.
- K922569: Tetric Light-Curing Composite, Ivoclar North America, Inc. (1992) Summary page 1.
- K951836: Compolglass Compoglass Sca, Ivoclar North America, Inc. (1995) Summary page 1.
- K950991: Dyract II Restorative, Dentsply Intl. (1995) Summary page 1.
- K962442: Hytac Aplitip/Hytac Osb, Espe GmbH & Co. Kg. (1996) Summary page 1.

## Indications for use
The SternOmega Dental Composite System is indicated for dental filling of cavities. The SternOmega Composite LC is indicated for filling of all classes of cavities. The SternOmega Compomer LC is indicated for Class V restorations, cervical abrasions and erosions, Class III restorations, and for restorations of all cavity classes including Classes I and II in deciduous teeth. The SternOmega Bonding Agent is indicated for all adhesive restorations with compomers and composites, including the SternOmega Composite LC and the SternOmega Compomer LC.

Source page: https://510kreport.com/device/K982692
Methodology: https://510kreport.com/methodology