Cleared Traditional

DEVICE FOR PROVIDING QUICK COUPLING FOR DENTAL PROSTHESES

K950261 · Dr. Joseph E. Grasso, D.D.S. · Dental

Sep 1997

Decision

960d

Days

Class 2

Risk

About This 510(k) Submission

K950261 is an FDA 510(k) clearance for the DEVICE FOR PROVIDING QUICK COUPLING FOR DENTAL PROSTHESES, a Implant, Endosseous, Root-form (Class II — Special Controls, product code DZE), submitted by Dr. Joseph E. Grasso, D.D.S. (West Simsbury, US). The FDA issued a Cleared decision on September 9, 1997, 960 days after receiving the submission on January 23, 1995. This device falls under the Dental review panel. Regulated under 21 CFR 872.3640.

Submission Details

510(k) Number	K950261 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 23, 1995
Decision Date	September 09, 1997
Days to Decision	960 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Statement