# K020092: Temphase

- Pathway: 510(k) (Traditional)
- Applicant: Kerr Dental Materials Center
- Decided: Feb 22, 2002 after 43 days
- Product code: EBG (Crown And Bridge, Temporary, Resin)
- Device class: 2
- Regulation: 21 CFR 872.3770
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
5 later devices descend from it; 3 cite it directly.
0 of 6 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) TempFil C&B: named in the summary without a submission number

## Most influential descendants
- K102917: Fixtemp C&B (2011), 2 descendants of its own
- K171729: Fixtemp C&B (2017), 1 descendant of its own
- K241226: Fixtemp® C&B 4:1 (2024), 0 descendants of its own
- K052800: Provisional Inlay/Onlay Kit (2006), 0 descendants of its own
- K021457: Flex Span Temporary Crown & Bridge Material (2002), 0 descendants of its own

## Indications for use
Temphase is a chemically catalyzed, highly filled, resin based restorative material used to fabricate temporary crowns and bridges.

Source page: https://510kreport.com/device/K020092
Methodology: https://510kreport.com/methodology