Composite Aligner Button
510(k) K080246
Composite Aligner Button is a medical device (FDA Class II; FDA product code NXC, Aligner, Sequential) made by Dentsply Interntional, cleared under FDA 510(k) K080246 on 11 Apr 2008, 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 | NumberK080246 | Date11 Apr 2008 | StatusActive |
Official records
- FDA 510(k) database K080246
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- NXC
- Device class
- Class II
- Regulation
- 21 CFR Part 872.5470
- Advisory committee
- Dental
- FDA decision
- SESE Substantially Equivalent
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