Sensi Temp® 70055
Sensi Temp® 70055 is a Class II device made by Sultan Healthcare Inc, cleared under FDA 510(k) K051952 on 7 Sep 2005 and listed in FDA GUDID since 23 Sep 2016 (UDI-DI D687700551), 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 | GUDID listing | NumberD687700551 | Date23 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK051952 | Date7 Sep 2005 | StatusActive |
Official records
- FDA 510(k) database K051952
Across registries
- FDA 510(k) K051952 decided 7 Sep 2005 Active
- FDA GUDID UDI-DI D687700551 listed 23 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K051952
- Listed FDA GUDID D687700551
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Sensi Temp®
- Generic name
- Dental composite resin
- Model / reference
- 70055
- Primary DI / UDI-DI
- D687700551
- 510(k) Number
- FDA product code
- EMA
- GMDN term
- Dental composite resin
- Device class
- Class II
- Regulation number
- 872.3275
- GUDID distribution status
- In Commercial Distribution
- Size
- Total Volume — 25 Milliliter
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