Mega Isq
by Osstell AB
510(k) K132401
Mega Isq is a medical device (FDA Class I; FDA product code EKX, Handpiece, Direct Drive, Ac-Powered) made by Osstell AB, cleared under FDA 510(k) K132401 on 9 Apr 2014, 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 | NumberK132401 | Date9 Apr 2014 | StatusActive |
Official records
- FDA 510(k) database K132401
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- EKX
- Device class
- Class I
- Regulation
- 21 CFR Part 872.4200
- Advisory committee
- Dental
- FDA decision
- SESE Substantially Equivalent
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