Dental Dam
510(k) K954990
Dental Dam is a medical device (FDA Class I; FDA product code EIE, Dam, Rubber) made by The Hygenic Company, LLC, cleared under FDA 510(k) K954990 on 26 Jan 1996, 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 | NumberK954990 | Date26 Jan 1996 | StatusActive |
Official records
- FDA 510(k) database K954990
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- EIE
- FDA applicant
- The Hygenic Corp.
- 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).
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- PULPDENT PUTTY DAM by Pulpdent Corporation
- DENTAL RUBBER DAM by ASEPTICO, INC.
- BEYOND® BlueSeal® Gingival Protection (5 pack) BY-PD02205 by Beyond International Inc.
- BRITESMILE MASKING CREAM by Britesmile, Inc.
- ROYAL SHIELD RUBBER DAMS by Elastomade Accessories Sdn Bhd
- DENTAL RUBBERDAM by Center For Marketing Services
- MADEGOM LTDA. DENTAL DAM by Madegom
- DREAM DAM by Dental Dam, Inc.
- RUBBER DAM by Hygienic Dental Mfg., Co., The