# K964981: Tempfil C&B

- Pathway: 510(k) (Traditional)
- Applicant: Sybron Dental Specialties, Inc.
- Decided: Feb 10, 1997 after 60 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.
No later device cites it as a predicate yet.
0 of 1 device 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) Luxatemp (DMG): named in the summary without a submission number
- (no number) Protemp Garant (ESPE): named in the summary without a submission number
- (no number) Integrity (L. D. Caulk): named in the summary without a submission number

## Indications for use
Provisional or temporary restorative materials are used in dentistry for treatment procedures not intended to be permanent or final. The purpose of the temporary material is to protect a prepared tooth surface during the interim period until the permanent restoration is available. An example of this interim period is the time that passes while porcelain or metal prosthetic devices are being fabricated in a dental laboratory. Another purpose of a temporary restoration is to provide an esthetically pleasing appearance for the patient during this interim period.

Source page: https://510kreport.com/device/K964981
Methodology: https://510kreport.com/methodology