# K022522: Pulpdent Putty Dam

- Pathway: 510(k) (Traditional)
- Applicant: Pulpdent Corporation
- Decided: Sep 26, 2002 after 58 days
- Product code: EIE (Dam, Rubber)
- Device class: 1
- Regulation: 21 CFR 872.6300
- 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) Ultra Dent Opal Dam: named in the summary without a submission number
- (no number) Den-Mat Paint On Rubber Dam: named in the summary without a submission number
- (no number) Premier Perfecta Block Out Resin: named in the summary without a submission number
- (no number) Shofu Niveous Liquid Dam: named in the summary without a submission number
- (no number) Luma Lite Luma Block: named in the summary without a submission number
- (no number) Interdent Fast Dam: named in the summary without a submission number
- (no number) BriteSmile Barrier Material: named in the summary without a submission number

## Indications for use
PULPDENT PUTTY DAM is a light-cured resin used by the dental professional during bleaching, air abrasion and etching procedures. PULPDENT PUTTY DAM protects soft tissue by creating a physical barrier.

Source page: https://510kreport.com/device/K022522
Methodology: https://510kreport.com/methodology