Cleartemp
510(k) K111017
Cleartemp is a Class II device made by Ultradent Products, Inc., cleared under FDA 510(k) K111017 on 6 Jun 2011, 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 | NumberK111017 | Date6 Jun 2011 | StatusActive |
Official records
- FDA 510(k) database K111017
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- EMA
- Device class
- Class II
- Regulation
- 21 CFR Part 872.3275
- Advisory committee
- Dental
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K111017
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| ClearTemp LC 3518 | 3518 / 3518 | 00883205045775 | On the market | |
| ClearTemp LC 3518 | 3518 / 3518 | 00883205106674 | On the market | |
| ClearTemp LC S3518 | S3518 / S3518 | 00883205102744 | On the market | |
| ClearTemp LC S3518 | S3518 / S3518 | 00883205045782 | On the market |
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