# K060698: Cement-IT All Purpose, Model N97

- Pathway: 510(k) (Traditional)
- Applicant: Pentron Clinical Technologies
- Decided: May 10, 2006 after 55 days
- Product code: EMA (Cement, Dental)
- Device class: 2
- Regulation: 21 CFR 872.3275
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K041474 (2004). 1 ancestor in all.
8 later devices descend from it; 2 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041474: Maxcem, Sybron Dental Specialties, Inc. (2004) Summary page 1.

## Most influential descendants
- K102703: Build-IT Total Core (2011), 3 descendants of its own
- K081913: Metacem, Meta P&Bond, Metacem Silane Ceramic Primer (2008), 3 descendants of its own
- K171449: Metacem (2018), 1 descendant of its own
- K153127: everX Posterior (2016), 1 descendant of its own
- K261166: Dia-Cem (2026), 0 descendants of its own

## Recalls of this device
- Jul 8, 2011 · Not classified · Z-0186-2012: Pentron is voluntarily recalling the Breeze Self Adhesive Resin Cement because it was discovered that there may be a curing problem that may cause cemented crowns to fall off after use of the product.
- Dec 2, 2010 · Not classified · Z-1100-2012: The recall was initiated because Pentron Clinical has confirmed that the Breeze Self-Adhesive Resin Cement exhibits faster than expected gel and set times. If the work time is exceeded when using this

## Indications for use
Cement-It All Purpose product is intended for cementation of porcelain, resin and metal-based inlays, onlays, crowns, bridges and posts. The material is not recommended for use on veneer restorations.

Source page: https://510kreport.com/device/K060698
Methodology: https://510kreport.com/methodology