Cleared Traditional

COUPLING DEVICE FOR DENTAL PROSTHESIS

K950259 · Dr. Joseph E. Grasso, D.D.S. · Dental
Dec 1996
Decision
683d
Days
Class 1
Risk

About This 510(k) Submission

K950259 is an FDA 510(k) clearance for the COUPLING DEVICE FOR DENTAL PROSTHESIS, a Attachment, Precision, All (Class I — General Controls, product code EGG), submitted by Dr. Joseph E. Grasso, D.D.S. (West Simsbury, US). The FDA issued a Cleared decision on December 6, 1996, 683 days after receiving the submission on January 23, 1995. This device falls under the Dental review panel. Regulated under 21 CFR 872.3165.

Submission Details

510(k) Number K950259 FDA.gov
FDA Decision Cleared SESE
Date Received January 23, 1995
Decision Date December 06, 1996
Days to Decision 683 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement

Device Classification

Product Code EGG — Attachment, Precision, All
Device Class Class I — General Controls
CFR Regulation 21 CFR 872.3165

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