Cleared Traditional

K943644 - IMPLANTECH TEMPORAL IMPLANT

K943644 is an FDA 510(k) clearance for IMPLANTECH TEMPORAL IMPLANT, manufactured by Implantech Associates, Inc.. The device is a Class 2 General & Plastic Surgery device with product code FWP cleared through the Traditional 510(k) pathway after a 83-day FDA review.

K943644 · Implantech Associates, Inc. · General & Plastic Surgery device
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Oct 1994
Decision
83d
Days
Class 2
Risk

K943644 is an FDA 510(k) clearance for the IMPLANTECH TEMPORAL IMPLANT. Classified as Prosthesis, Chin, Internal (product code FWP), Class II - Special Controls.

Submitted by Implantech Associates, Inc. (Van Nuys, US). The FDA issued a Cleared decision on October 18, 1994 after a review of 83 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.3550 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Implantech Associates, Inc. devices

FDA 510(k) Submission Details - K943644

510(k) Number K943644 FDA.gov
FDA Decision Cleared Substantially Equivalent - Third Party Review (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 -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
32d faster than avg
Panel avg: 115d · This submission: 83d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FWP Device Classification - Class 2, Special Controls

Product Code FWP Prosthesis, Chin, Internal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.3550
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - FWP Prosthesis, Chin, Internal

All 46
Devices cleared under the same product code (FWP) and FDA review panel - the closest regulatory comparables to K943644.
MEDPOR BARRIER SURGICAL IMPLANT BIOMATERIAL
K952677 · Porex Surgical, Inc. · Aug 1995
GORE-TEX SAM FACIAL IMPLANT
K946267 · W.L. Gore & Associates, Inc. · Mar 1995
FLEXIBLE HYDROXYLAPATITE/SILICONE SOFT CHIN IMPLAN
K925610 · Microtek Medical, Inc. · Nov 1994
GORE-TEX FACIAL IMPLANT
K933367 · W.L. Gore & Associates, Inc. · Jul 1994
GORETEX SAM FACIAL IMPLANT
K942280 · W.L. Gore & Associates, Inc. · Jul 1994
CHIN WAFER
K921581 · Implantech Associates, Inc. · May 1992