# K982895: Sternomega Compomer Cement

- Pathway: 510(k) (Traditional)
- Applicant: Sterngold/Implamed
- Decided: Oct 9, 1998 after 53 days
- Product code: EMA (Cement, Dental)
- Device class: 2
- Regulation: 21 CFR 872.3275
- 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 K924151 (1992). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K940513: Optibond, Kerr Corporation (Danbury) (1994) Summary page 1.
- K933030: Panavia 21, Kuraray Co. (1994) Summary page 1.
- K940030: Bisco Composite, Bisco, Inc. (1994) Summary page 1.
- K922249: Flexi-Flow Cement Natural, Essential Dental Systems, Inc. (1994) Summary page 1.
- K960464: C & B Metabond (Modification), Parkell, Inc. (1996) Summary page 1.
- K931309: Variolink, Ivoclar North America, Inc. (1993) Summary page 1.
- K940914: New Luting Cement Material (NLC), Dentsply Intl. (1994) Summary page 1.
- K946100: Fuji Duet, GC America, Inc. (1995) Summary page 1.
- K924151: Bisco D/C Resinomer, Bisco, Inc. (1992) Summary page 1.
- (no number) Dyract Cem: named in the summary without a submission number
- (no number) Cement-It: named in the summary without a submission number
- (no number) ABC Dual Adhesive Bridge Cement: named in the summary without a submission number

## Cited in the summary but kept off the family tree
- K943596: Vantage, for Adac Gamma Cameras, Adac Laboratories (1995). Our OCR of the scanned summary read K943596, FDA’s number for Vantage, for Adac Gamma Cameras (Adac Laboratories). Its FDA name has none of the distinctive words the summary uses for the device it names, “Duolink”. Kept off the family tree. Summary page 1.

## Indications for use
SternOmega Compomer Cement Automix is indicated for use in permanent luting of crowns, bridges, inlays and onlays and for luting ceramic crowns, inlays and veneers.

Source page: https://510kreport.com/device/K982895
Methodology: https://510kreport.com/methodology