Cleared Traditional

K943388 - GC SURFLEX F

K943388 is an FDA 510(k) clearance for GC SURFLEX F, manufactured by GC America, Inc.. The device is a Class 2 Dental device with product code ELW cleared through the Traditional 510(k) pathway after a 61-day FDA review.

K943388 · GC America, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1994
Decision
61d
Days
Class 2
Risk

K943388 is an FDA 510(k) clearance for the GC SURFLEX F. Classified as Material, Impression (product code ELW), Class II - Special Controls.

Submitted by GC America, Inc. (Alsip, US). The FDA issued a Cleared decision on September 12, 1994 after a review of 61 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3660 - the FDA dental device regulatory 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.

FDA 510(k) Submission Details - K943388

510(k) Number K943388 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 13, 1994
Decision Date September 12, 1994
Days to Decision 61 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
67d faster than avg
Panel avg: 128d · This submission: 61d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ELW Device Classification - Class 2, Special Controls

Product Code ELW Material, Impression
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3660
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 Dental devices follow this clearance model.

Regulatory Peers - ELW Material, Impression

All 401
Devices cleared under the same product code (ELW) and FDA review panel - the closest regulatory comparables to K943388.
ALGI-BAND
K951237 · Health-Dent Intl., Inc. · Apr 1995
S & C VINYL POLYSILOXANE IMPRESSION MATERIAL
K951075 · S & C Polymer GmbH · Mar 1995
POLYSIL (VINYL POLYSILOXAN IMPRESSION MATERIAL)
K945142 · Scican · Jan 1995
THIXOFLEX
K935896 · Zhermack Dental Production · Sep 1994
ELITE PUTTY HARD
K931242 · Zhermack Dental Production · Aug 1994
ELITE PUTTY SOFT
K935884 · Zhermack Dental Production · Aug 1994
K943388 · GC SURFLEX F
Download PDF GC America, Inc.