510(k) K033785
K033785 is an FDA 510(k) premarket notification submitted by Discus Dental, Inc. for the device "PROACTIVE CARE PROPHYLAXIS PASTE WITH FLUORIDE". The FDA issued a decision of Substantially Equivalent on June 18, 2004. The device falls under product code EJR (Agent, Polishing, Abrasive, Oral Cavity), a Class I device regulated under 21 CFR 872.6030. Discus Dental, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 18, 2004
- Date Received
- December 4, 2003
- 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