510(k) K102053
K102053 is an FDA 510(k) premarket notification submitted by Sunstar Americas, Inc. for the device "BUTLER CALCI-FLOR PROPHYLAXIS PASTE". The FDA issued a decision of Substantially Equivalent on February 3, 2011. The device falls under product code EJR (Agent, Polishing, Abrasive, Oral Cavity), a Class I device regulated under 21 CFR 872.6030. Sunstar Americas, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 3, 2011
- Date Received
- July 22, 2010
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Agent, Polishing, Abrasive, Oral Cavity
- Device Class
- Class I
- Regulation Number
- 872.6030
- Review Panel
- DE
- Submission Type