# K081810: Pulpdent Temporary Crown and Bridge Material

- Pathway: 510(k) (Traditional)
- Applicant: Pulpdent Corporation
- Decided: Sep 17, 2008 after 83 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.
7 later devices descend from it; 1 cites it directly.
0 of 8 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) Luxatemp, DMG: named in the summary without a submission number
- (no number) Luxatemp Solar, DMG: named in the summary without a submission number
- (no number) Sci-Span, Scientific Pharmaceuticals Inc.: named in the summary without a submission number
- (no number) Integrity, Dentsply International: named in the summary without a submission number
- (no number) CosmeTemp, Cosmedent Inc.: named in the summary without a submission number

## Most influential descendants
- K120784: Tuff-Temp 2.0 (2012), 6 descendants of its own
- K123265: Rmgi Low Viscosity (2012), 5 descendants of its own
- K130223: Rmgi Fill (2013), 4 descendants of its own
- K153249: Pulpdent Solo Flowable Composite with MCP (2016), 1 descendant of its own
- K250953: Equia LC One (2025), 0 descendants of its own

## Indications for use
Pulpdent Temporary Crown and Bridge Material is used by the dental professional to make a temporary prosthesis, such as a crown or bridge, for use until a permanent restoration is fabricated.

Source page: https://510kreport.com/device/K081810
Methodology: https://510kreport.com/methodology