# K073173: Self-Adhesive Resin Cement

- Pathway: 510(k) (Traditional)
- Applicant: Dentsply Interntional
- Decided: Jan 23, 2008 after 71 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: 4 generations back to K900510 (1990). 10 ancestors in all.
6 later devices descend from it; 2 cite it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020256: Unicem, 3M Espe AG Dental Products (2002) Summary page 1.
- K041474: Maxcem, Sybron Dental Specialties, Inc. (2004) Summary page 1.

## Most influential descendants
- K081913: Metacem, Meta P&Bond, Metacem Silane Ceramic Primer (2008), 3 descendants of its own
- K210259: Parkell Self-Adhesive Cement (2022), 1 descendant of its own
- K171449: Metacem (2018), 1 descendant of its own
- K261166: Dia-Cem (2026), 0 descendants of its own
- K253337: REGEN Bioactive Cement (2026), 0 descendants of its own

## Indications for use
Self-adhesive Resin Cement is intended for the cementation of indirect restoratives including ceramic, composite and metal-based inlays, onlays, crowns, bridges, and posts.

Source page: https://510kreport.com/device/K073173
Methodology: https://510kreport.com/methodology