Wire Sterilization Package with Indicators
510(k) K143117
Wire Sterilization Package with Indicators is a Class II device made by American Orthodontics, cleared under FDA 510(k) K143117 on 29 Oct 2015, 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 | NumberK143117 | Date29 Oct 2015 | StatusActive |
Official records
- FDA 510(k) database K143117
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- FRG
- Device class
- Class II
- Regulation
- 21 CFR Part 880.6850
- Advisory committee
- General Hospital
- FDA decision
- SESE Substantially Equivalent
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