# K041474: Maxcem

- Pathway: 510(k) (Traditional)
- Applicant: Sybron Dental Specialties, Inc.
- Decided: Jul 21, 2004 after 49 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.
25 later devices descend from it; 4 cite it directly.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) UniCem: named in the summary without a submission number

## Most influential descendants
- K081583: Clearfil SA Cement (2008), 9 descendants of its own
- K060698: Cement-IT All Purpose, Model N97 (2006), 8 descendants of its own
- K111982: Clearfil DC Core Plus (2011), 6 descendants of its own
- K073173: Self-Adhesive Resin Cement (2008), 6 descendants of its own
- K120379: Panavia SA Cement Automix Value Pack (Universal (A2), White) Panavia SA Cement Automix (Universal (A2), White) Panavia S (2012), 5 descendants of its own

## Indications for use
MaxCem is intended for indirect cementation of porcelain, resin and metal-based inlays, onlays, crowns, bridges and posts. The material is not recommended for use on veneer indications.

Source page: https://510kreport.com/device/K041474
Methodology: https://510kreport.com/methodology