# K980922: Protec Cem.

- Pathway: 510(k) (Traditional)
- Applicant: Ivoclar North America, Inc.
- Decided: Apr 30, 1998 after 50 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
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
- K023649: Vitique System (2003), 0 descendants of its own

## Indications for use
Protec Cem is intended to be used with crowns and bridges constructed of Targis/Vectris material on conventionally prepared stumps with adequate mechanical retention. Cementation of metal or Porcelain Fused to Metal (PFM) inlays, partial crowns, crowns, bridges, as well as metal root canal posts, metal post build ups, and orthodontic bands.

Source page: https://510kreport.com/device/K980922
Methodology: https://510kreport.com/methodology