510(k) K170330
K170330 is an FDA 510(k) premarket notification submitted by 3M Company for the device "3M Protemp Cement Temporary Dental Cement". The FDA issued a decision of Substantially Equivalent on Feb 6, 2017. The device falls under product code EMA (Cement, Dental), a Class II device regulated under 21 CFR 872.3275. 3M Company has 334 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Feb 6, 2017
- Date Received
- Feb 2, 2017
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Cement, Dental
- Device Class
- Class II
- Regulation Number
- 872.3275
- Review Panel
- DE
- Submission Type
- 510(k)