510(k) K950259

COUPLING DEVICE FOR DENTAL PROSTHESIS by Dr. Joseph E. Grasso, D.D.S. — Product Code EGG

K950259 is an FDA 510(k) premarket notification submitted by Dr. Joseph E. Grasso, D.D.S. for the device "COUPLING DEVICE FOR DENTAL PROSTHESIS". The FDA issued a decision of Substantially Equivalent on December 6, 1996. The device falls under product code EGG (Attachment, Precision, All), a Class I device regulated under 21 CFR 872.3165. 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
December 6, 1996
Date Received
January 23, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Attachment, Precision, All
Device Class
Class I
Regulation Number
872.3165
Review Panel
DE
Submission Type