# K032953: Embrace Wetbond Restoration and PFM Repair Kit

- Pathway: 510(k) (Traditional)
- Applicant: Pulpdent Corporation
- Decided: Dec 10, 2003 after 79 days
- Product code: KLE (Agent, Tooth Bonding, Resin)
- Device class: 2
- Regulation: 21 CFR 872.3200
- 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) Kuraray Clearfil Porcelain Repair Kit: named in the summary without a submission number
- (no number) Ultradent Porcelain Repair Kit: named in the summary without a submission number
- (no number) Ivoclar Vivadent Ceramic Repair Kit: named in the summary without a submission number
- (no number) Pulpdent Embrace First Coat: named in the summary without a submission number
- (no number) Pulpdent Embrace Seal-n-Shine: named in the summary without a submission number
- (no number) Pulpdent Embrace Opaquer: named in the summary without a submission number
- (no number) Pulpdent Kool-Dam: named in the summary without a submission number
- (no number) Pulpdent Porcelain Etch Gel: named in the summary without a submission number

## Indications for use
Embrace WetBond Restoration & PFM Repair Kit is a convenience kit used by dentists to repair restorations. The components were designed for bonding to all restorative, metal and ceramic surfaces, including precious and non-precious metals, porcelain and enamel. The kit provides materials to prepare, prime, protect, opaque, seal, finish and polish porcelain and restorative materials.

Source page: https://510kreport.com/device/K032953
Methodology: https://510kreport.com/methodology