IS3
510(k) K180527
IS3 is a Class I device made by Hiossen, Inc., cleared under FDA 510(k) K180527 on 16 May 2018, 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 | NumberK180527 | Date16 May 2018 | StatusActive |
Official records
- FDA 510(k) database K180527
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- Withdrawn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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