Cleared Traditional

K831269 - VINYLAC PRESS-PACK DENTURE RESIN

K831269 is an FDA 510(k) clearance for VINYLAC PRESS-PACK DENTURE RESIN, manufactured by Astron Dental Corp.. The device is a Class 2 Dental device with product code EBI cleared through the Traditional 510(k) pathway after a 51-day FDA review.

K831269 · Astron Dental Corp. · Dental device
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Jun 1983
Decision
51d
Days
Class 2
Risk

K831269 is an FDA 510(k) clearance for the VINYLAC PRESS-PACK DENTURE RESIN. Classified as Resin, Denture, Relining, Repairing, Rebasing (product code EBI), Class II - Special Controls.

Submitted by Astron Dental Corp. (Mchenry, US). The FDA issued a Cleared decision on June 8, 1983 after a review of 51 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 Astron Dental Corp. devices

FDA 510(k) Submission Details - K831269

510(k) Number K831269 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 18, 1983
Decision Date June 08, 1983
Days to Decision 51 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
77d faster than avg
Panel avg: 128d · This submission: 51d
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 265
Devices cleared under the same product code (EBI) and FDA review panel - the closest regulatory comparables to K831269.
RESIL
K840548 · Parker Laboratories, Inc. · Apr 1984
DENTURE BASE RESIN
K834409 · Dentsply Intl. · Feb 1984
DENTURE RELINING, REPAIR/REBASING RESIN
K831647 · Dentsply Intl. · Jun 1983
SOFTIC 49
K821230 · The Healthcare Group Laboratories, Inc. · May 1982
SELF-CURING HARD DENTURE LINER
K820673 · Coe Laboratories, Inc. · Apr 1982
SR-IVOCAP
K810687 · J. Aderer, Inc. · Apr 1981