# K961472: Dental Dam Silicone

- Pathway: 510(k) (Traditional)
- Applicant: Worldwide Dental, Inc.
- Decided: Aug 7, 1996 after 112 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) Hygienic brand latex dam: named in the summary without a submission number

## Indications for use
The Roeko silicone dam is intended for use as a physical barrier around a tooth to allow isolation from fluids in the mouth during dental procedures. The tooth is isolated by insertion through a hole punched in the center of the silicone sheet. The dental dam is inserted into the oral cavity using frame and clamp accessories. These indications are the same as those claimed for the predicate device.

Source page: https://510kreport.com/device/K961472
Methodology: https://510kreport.com/methodology