Mtm(R) Clear Aligner
by Dentsply International Inc.
510(k) K132145
Mtm(R) Clear Aligner is a Class II device made by Dentsply International Inc., cleared under FDA 510(k) K132145 on 11 Oct 2013, 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 | NumberK132145 | Date11 Oct 2013 | StatusActive |
Official records
- FDA 510(k) database K132145
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- NXC
- FDA applicant
- Dentsply International, Inc.
- Device class
- Class II
- Regulation
- 21 CFR Part 872.5470
- Advisory committee
- Dental
- FDA decision
- SESE Substantially Equivalent
Similar devices
Other devices filed under FDA product code NXC (Aligner, Sequential).
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- Clear Image Aligners by Specialty Appliance Works, Inc.
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- HIT Clear Aligner by Cdb Corporation
- eCligner by Eclear International Co., Ltd.
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- MyClearALIGN Dental Aligner System by Key Dental Technologies, LLC