510(k) K040988
K040988 is an FDA 510(k) premarket notification submitted by Pascal Co., Inc. for the device "ZIRCON-F PROPHYLAXIS PASTE". The FDA issued a decision of Substantially Equivalent on Jul 7, 2004. The device falls under product code EJR (Agent, Polishing, Abrasive, Oral Cavity), a Class I device regulated under 21 CFR 872.6030. Pascal Co., Inc. has 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jul 7, 2004
- Date Received
- Apr 15, 2004
- 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
- 510(k) Exempt