Light Cure Dental Dam
by Prime Dental Manufacturing, Inc.
510(k) K021524
Light Cure Dental Dam is a medical device (FDA Class I; FDA product code EIE, Dam, Rubber) made by Prime Dental Manufacturing, Inc., cleared under FDA 510(k) K021524 on 19 Jul 2002, 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 | NumberK021524 | Date19 Jul 2002 | StatusActive |
Official records
- FDA 510(k) database K021524
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- Withdrawn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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