Handidam
510(k) K884828
Handidam is a medical device (FDA Class I; FDA product code EIE, Dam, Rubber) made by Aseptico, Inc., cleared under FDA 510(k) K884828 on 3 Feb 1989, 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 | NumberK884828 | Date3 Feb 1989 | StatusActive |
Official records
- FDA 510(k) database K884828
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- Withdrawn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
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- ROYAL SHIELD NON-STERILE POWDER-FREE RUBBER DAMS by Elastomade Accessories Sdn Bhd
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- IVORY PREMIUM RUBBER DAM by Columbus Dental Mfg. Co.