Cleared Traditional

K831647 - DENTURE RELINING

K831647 is the FDA 510(k) clearance for DENTURE RELINING by Dentsply Intl.. It is a Class 2 Dental device (product code EBI) cleared through the Traditional 510(k) pathway after a 38-day FDA review.

K831647 · Dentsply Intl. · Dental device
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Jun 1983
Decision
38d
Days
Class 2
Risk

K831647 is an FDA 510(k) clearance for the DENTURE RELINING, REPAIR/REBASING RESIN. Classified as Resin, Denture, Relining, Repairing, Rebasing (product code EBI), Class II - Special Controls.

Submitted by Dentsply Intl. (Mchenry, US). The FDA issued a Cleared decision on June 30, 1983 after a review of 38 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 Dentsply Intl. devices

Submission Details

510(k) Number K831647 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 23, 1983
Decision Date June 30, 1983
Days to Decision 38 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
89d faster than avg
Panel avg: 127d · This submission: 38d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 149
Devices cleared under the same product code (EBI) and FDA review panel - the closest regulatory comparables to K831647.
BOSWORTH DENT-ALL
K840405 · Harry J. Bosworth Co. · May 1984
RESIL
K840548 · Parker Laboratories, Inc. · Apr 1984
DENTURE BASE RESIN
K834409 · Dentsply Intl. · Feb 1984
MAXUM DENTURE RESIN
K800400 · Dentsply Intl. · Mar 1980
DENTURE BASE RESIN
K792042 · Dentsply Intl. · Nov 1979
REPRODENT
K790325 · Premier Dental Products Co. · Mar 1979