Cleared Traditional

PROPHYLAXIS PACK

K950773 · Transidyne General Corp. · Dental
Mar 1995
Decision
38d
Days
Class 1
Risk

About This 510(k) Submission

K950773 is an FDA 510(k) clearance for the PROPHYLAXIS PACK, a Handpiece, Contra- And Right-angle Attachment, Dental (Class I — General Controls, product code EGS), submitted by Transidyne General Corp. (Spartanburg, US). The FDA issued a Cleared decision on March 31, 1995, 38 days after receiving the submission on February 21, 1995. This device falls under the Dental review panel. Regulated under 21 CFR 872.4200.

Submission Details

510(k) Number K950773 FDA.gov
FDA Decision Cleared SESK
Date Received February 21, 1995
Decision Date March 31, 1995
Days to Decision 38 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement

Device Classification

Product Code EGS — Handpiece, Contra- And Right-angle Attachment, Dental
Device Class Class I — General Controls
CFR Regulation 21 CFR 872.4200

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