Cleared Traditional

K782139 - ZYLOX

K782139 is an FDA 510(k) clearance for ZYLOX, manufactured by Premier Dental Products Co.. The device is a Class 2 Dental device with product code ELW cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K782139 · Premier Dental Products Co. · Dental device
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Feb 1979
Decision
56d
Days
Class 2
Risk

K782139 is an FDA 510(k) clearance for the ZYLOX. Classified as Material, Impression (product code ELW), Class II - Special Controls.

Submitted by Premier Dental Products Co. (Mchenry, US). The FDA issued a Cleared decision on February 21, 1979 after a review of 56 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 Premier Dental Products Co. devices

FDA 510(k) Submission Details - K782139

510(k) Number K782139 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 27, 1978
Decision Date February 21, 1979
Days to Decision 56 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
71d faster than avg
Panel avg: 127d · This submission: 56d
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 256
Devices cleared under the same product code (ELW) and FDA review panel - the closest regulatory comparables to K782139.
SILAGUM
K792363 · Parkell, Inc. · Jan 1980
IMPRESSION MATERIAL, RUBBER
K790592 · Wallace A. Erickson & Co. · Jun 1979
DENTAL ALGINATE IMPRESSION MATERIAL
K790595 · Wallace A. Erickson & Co. · Jun 1979
REFLECT IMPRESSION MATERIAL
K781689 · Kerr Corporation (Danbury) · Nov 1978
DENTAL SILICONE IMPRESSION MATERIAL
K781083 · Crown Delta Corp. · Aug 1978
REPROSIL
K781151 · Dentsply Intl. · Aug 1978