Cleared Traditional

K844329 - SURFLEX F

K844329 is an FDA 510(k) clearance for SURFLEX F, manufactured by G-C Intl. Corp.. The device is a Class 2 Dental device with product code ELW cleared through the Traditional 510(k) pathway after a 26-day FDA review.

K844329 · G-C Intl. Corp. · Dental device
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Dec 1984
Decision
26d
Days
Class 2
Risk

K844329 is an FDA 510(k) clearance for the SURFLEX F. Classified as Material, Impression (product code ELW), Class II - Special Controls.

Submitted by G-C Intl. Corp. (Scottsdale, US). The FDA issued a Cleared decision on December 3, 1984 after a review of 26 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.

View all G-C Intl. Corp. devices

FDA 510(k) Submission Details - K844329

510(k) Number K844329 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 07, 1984
Decision Date December 03, 1984
Days to Decision 26 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
101d faster than avg
Panel avg: 127d · This submission: 26d
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 201
Devices cleared under the same product code (ELW) and FDA review panel - the closest regulatory comparables to K844329.
PROOF ALGINATE IMPRESSION MATERIAL
K854855 · Sybron Corp. · Jan 1986
SEPTOSIL SILICONE FOR PRECISION IMPRESSION
K851388 · Specialites Septodont · May 1985
76 ELW BITE CHECKER SILICONE
K851469 · G-C Intl. Corp. · May 1985
PERFOURM
K842324 · Cutter Laboratories, Inc. · Nov 1984
ODONTIC CENTRIC(BITE) REGIST. PASTE
K830044 · Wallace A. Erickson & Co. · Apr 1983
SYBRON/KERR MIRROR 3
K820183 · Sybron Corp. · Feb 1982