Cleared Traditional

K943644 - IMPLANTECH TEMPORAL IMPLANT
(FDA 510(k) Clearance)

K943644 · Implantech Associates, Inc. · General & Plastic Surgery

Oct 1994

Decision

83d

Days

Class 2

Risk

K943644 is an FDA 510(k) clearance for the IMPLANTECH TEMPORAL IMPLANT. This device is classified as a Prosthesis, Chin, Internal (Class II — Special Controls, product code FWP).

Submitted by Implantech Associates, Inc. (Van Nuys, US). The FDA issued a Cleared decision on October 18, 1994, 83 days after receiving the submission on July 27, 1994.

This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.3550.

Submission Details

510(k) Number	K943644 FDA.gov
FDA Decision	Cleared ST
Date Received	July 27, 1994
Decision Date	October 18, 1994
Days to Decision	83 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	—