# K073209: Maxcem 2

- Pathway: 510(k) (Traditional)
- Applicant: Kerr Corporation
- Decided: Jan 29, 2008 after 76 days
- Product code: MZW (Dental Cement W/Out Zinc-Oxide Eugenol As An Ulcer Covering For Pain Relief)
- Device class: 2
- Regulation: 21 CFR 872.3275
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
27 later devices descend from it; 6 cite it directly.
0 of 28 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) Maxcem: named in the summary without a submission number
- (no number) Nexus 3: named in the summary without a submission number
- (no number) Optibond Solo Plus 3: named in the summary without a submission number

## Most influential descendants
- K094007: Unicem (2010), 22 descendants of its own
- K100756: MALTA (2010), 19 descendants of its own
- K110508: Suglue-10 (2011), 8 descendants of its own
- K153231: G-Cem LinkForce, Dual Cure Activator, Try-In Paste, Multi Primer (2016), 5 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

## Recalls of this device
- Feb 22, 2013 · Class II · Z-1076-2013: Kerr Corporation is initiating this recall because raw material used to produce the Maxcem Elite is causing the material to prematurely polymerize in the syringe. The product could be difficult to ext
- Nov 10, 2011 · Not classified · Z-0390-2012: The specific lots of Maxcem Elite Refill Kit appear not to be authentic.
- Feb 3, 2011 · Not classified · Z-0915-2012: The recall was initiated because Kerr Corporation has confirmed that the use of the affected lot of Maxcem Elite may not provide users with a minimum of 2 minutes of worktime thereby causing the produ

## Indications for use
Maxcem 2 is intended for cementation of all indirect restorations including ceramic, resin and metal-based inlays, onlays, crowns, bridges, posts, and veneers*. Additional indications include core-buildup material, pit and fissure sealant, and cementation of crown restorations to implants. * Adhesive application on the prep is required for veneer cementation using Maxcem 2.

Source page: https://510kreport.com/device/K073209
Methodology: https://510kreport.com/methodology