Zylox
by Premier Dental Products Co.
510(k) K782139
Zylox is a Class II device made by Premier Dental Products Co., cleared under FDA 510(k) K782139 on 21 Feb 1979, 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 | NumberK782139 | Date21 Feb 1979 | StatusActive |
Official records
- FDA 510(k) database K782139
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- ELW
- Device class
- Class II
- Regulation
- 21 CFR Part 872.3660
- Advisory committee
- Dental
- FDA decision
- SESE Substantially Equivalent
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