# K982590: Tempbond Clear-2

- Pathway: 510(k) (Traditional)
- Applicant: Sybron Dental Specialties, Inc.
- Decided: Oct 8, 1998 after 76 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
No predicates in its family tree.
3 later devices descend from it; 1 cites it directly.
0 of 4 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) TempBond Clear: named in the summary without a submission number

## Most influential descendants
- K091735: DC Provi Cem Esthetic, Esthetic Multi F, Implant (2009), 2 descendants of its own
- K110759: Tempocem (2011), 1 descendant of its own
- K142446: Fixtemp Cement (2015), 0 descendants of its own

## Recalls of this device
- Sep 9, 2009 · Not classified · Z-0074-2010: The recall was initiated because the catalyst portion of the syringe may have polymerized, therefore making the product unusable.
- Aug 14, 2006 · Not classified · Z-1524-06: Low Bonding performance: The affected lots of product may not activate properly, which may cause lower than expected bonding performance (due to a low level of chemical cure initiator in the lots manu

## Indications for use
TempBond Clear - 2 is a dual-cured, temporary resin-based cement designed to be used in conjunction with temporary restorations such as crowns, bridges, inlays and onlays.

Source page: https://510kreport.com/device/K982590
Methodology: https://510kreport.com/methodology