510(k) K024343
K024343 is an FDA 510(k) premarket notification submitted by Usbiomaterials Corp. for the device "BUTLER GUM PROPHY PASTE WITH NOVAMIN". The FDA issued a decision of Substantially Equivalent on July 11, 2003. The device falls under product code EJR (Agent, Polishing, Abrasive, Oral Cavity), a Class I device regulated under 21 CFR 872.6030. Usbiomaterials Corp. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 11, 2003
- Date Received
- December 27, 2002
- 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