510(k) K150601
K150601 is an FDA 510(k) premarket notification submitted by Premier Dental Company Products for the device "Zeramic Adhesive Resin Cement". The FDA issued a decision of Substantially Equivalent on July 22, 2015. The device falls under product code EMA (Cement, Dental), a Class II device regulated under 21 CFR 872.3275. Premier Dental Company Products has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 22, 2015
- Date Received
- March 10, 2015
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Cement, Dental
- Device Class
- Class II
- Regulation Number
- 872.3275
- Review Panel
- DE
- Submission Type