Oralix Dc
by Gendex Corp.
510(k) K931001
Oralix Dc is a Class II device made by Gendex Corp., cleared under FDA 510(k) K931001 on 14 Sep 1993, 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 | NumberK931001 | Date14 Sep 1993 | StatusActive |
Official records
- FDA 510(k) database K931001
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- EHD
- Device class
- Class II
- Regulation
- 21 CFR Part 872.1800
- Advisory committee
- Dental
- FDA decision
- SESE Substantially Equivalent
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