510(k) K950260
K950260 is an FDA 510(k) premarket notification submitted by Dr. Joseph E. Grasso, D.D.S. for the device "QUICK COUPLING DEVICE FOR DENTAL PROSTHESES". The FDA issued a decision of Substantially Equivalent on September 9, 1997. The device falls under product code DZE (Implant, Endosseous, Root-Form), a Class II device regulated under 21 CFR 872.3640. Dr. Joseph E. Grasso, D.D.S. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 9, 1997
- Date Received
- January 23, 1995
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Implant, Endosseous, Root-Form
- Device Class
- Class II
- Regulation Number
- 872.3640
- Review Panel
- DE
- Submission Type