Rubber Dam Clamp
510(k) K923163
Rubber Dam Clamp is a medical device (FDA Class I; FDA product code EIE, Dam, Rubber) made by Aseptico, Inc., cleared under FDA 510(k) K923163 on 28 Dec 1992, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK923163 | Date28 Dec 1992 | StatusActive |
Official records
- FDA 510(k) database K923163
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- EIE
- Device class
- Class I
- Regulation
- 21 CFR Part 872.6300
- Advisory committee
- Dental
- FDA decision
- SESE Substantially Equivalent
Similar devices
Other devices filed under FDA product code EIE (Dam, Rubber).
- DREAM DAM by Dental Dam, Inc.
- armor LC by Mavrik Dental Systems, Ltd.
- RUBBER, DENTAL DAM (NON-STERILE) by Naturub Sdn. Bhd.
- BEYOND® BlueSeal® Gingival Protection Twin Pack BY-PD02202 by Beyond International Inc.
- DEN-MAT PAINT-ON RUBBER DAM by Den-Mat Corp.
- WEDJETS by The Hygenic Company, LLC
- POWER BLOCK by Kreativ, Inc.
- DENTAL DAM SILICONE by Worldwide Dental, Inc.
- GC TION GINGIVAL PROTECTOR by Gc America Inc.
- KITCHIN DENTAL ABCESS DRAIN by Kitchin, Inc.