510(k) K850675
K850675 is an FDA 510(k) premarket notification submitted by Scientific Pharmaceuticals, Inc. for the device "CURAY JOIN DENT DENTIN PRIMER". The FDA issued a decision of Substantially Equivalent on March 25, 1985. The device falls under product code EBD (Coating, Filling Material, Resin), a Class II device regulated under 21 CFR 872.3310. Scientific Pharmaceuticals, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 25, 1985
- Date Received
- February 21, 1985
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Coating, Filling Material, Resin
- Device Class
- Class II
- Regulation Number
- 872.3310
- Review Panel
- DE
- Submission Type