510(k) K935925
K935925 is an FDA 510(k) premarket notification submitted by Block Drug Company, Inc. for the device "VISION PROPHY PASTE WITH FLUORIDE". The FDA issued a decision of Substantially Equivalent on January 26, 1994. The device falls under product code EJR (Agent, Polishing, Abrasive, Oral Cavity), a Class I device regulated under 21 CFR 872.6030. Block Drug Company, Inc. has at least 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 26, 1994
- Date Received
- December 13, 1993
- 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