Cleared Traditional

K792427 - PERMA-CRYL 20

K792427 is an FDA 510(k) clearance for PERMA-CRYL 20, manufactured by Coe Laboratories, Inc.. The device is a Class 2 Dental device with product code EBI cleared through the Traditional 510(k) pathway after a 16-day FDA review.

K792427 · Coe Laboratories, Inc. · Dental device
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Dec 1979
Decision
16d
Days
Class 2
Risk

K792427 is an FDA 510(k) clearance for the PERMA-CRYL 20. Classified as Resin, Denture, Relining, Repairing, Rebasing (product code EBI), Class II - Special Controls.

Submitted by Coe Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 13, 1979 after a review of 16 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3760 - 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 Coe Laboratories, Inc. devices

FDA 510(k) Submission Details - K792427

510(k) Number K792427 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 27, 1979
Decision Date December 13, 1979
Days to Decision 16 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
111d faster than avg
Panel avg: 127d · This submission: 16d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EBI Device Classification - Class 2, Special Controls

Product Code EBI Resin, Denture, Relining, Repairing, Rebasing
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3760
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 - EBI Resin, Denture, Relining, Repairing, Rebasing

All 259
Devices cleared under the same product code (EBI) and FDA review panel - the closest regulatory comparables to K792427.
SELF-CURING HARD DENTURE LINER
K820673 · Coe Laboratories, Inc. · Apr 1982
SR-IVOCAP
K810687 · J. Aderer, Inc. · Apr 1981
MAXUM DENTURE RESIN
K800400 · Dentsply Intl. · Mar 1980
DENTURE BASE RESIN
K792042 · Dentsply Intl. · Nov 1979
REPRODENT
K790325 · Premier Dental Products Co. · Mar 1979
DENTURE RELINE MATERIAL
K780786 · Dentsply Intl. · Jun 1978