# K984248: Procem

- Pathway: 510(k) (Traditional)
- Applicant: Espe Dental AG
- Decided: Jan 8, 1999 after 42 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: 2 generations back to K812116 (1981). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K842994: Ema Freegenol Dental Cement, Int'L Corp. (1984) Summary page 1.
- K771451: Scutabond, Premier Dental Products Co. (1977) Summary page 1.
- K950203: Protemp (R) Garant, Espe GmbH & Co. Kg. (1995) Summary page 1.
- K960547: Dimension Penta/Dimension Garant L/Polyvinyl Siloxane Adhesive, Espe GmbH & Co. Kg. (1996) Summary page 1.
- (no number) Cavit® G: named in the summary without a submission number

## Indications for use
Provisional dental cement for the temporary fixation of: - temporary crowns and bridges - temporary inlays and onlays - definite restorations

Source page: https://510kreport.com/device/K984248
Methodology: https://510kreport.com/methodology