Cleared Traditional

K882482 - TRIAD ORTHODONTIC GEL

K882482 is an FDA 510(k) clearance for TRIAD ORTHODONTIC GEL, manufactured by Dentsply Intl.. The device is a Class 2 Dental device with product code EBI cleared through the Traditional 510(k) pathway after a 57-day FDA review.

K882482 · Dentsply Intl. · Dental device
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Aug 1988
Decision
57d
Days
Class 2
Risk

K882482 is an FDA 510(k) clearance for the TRIAD ORTHODONTIC GEL. Classified as Resin, Denture, Relining, Repairing, Rebasing (product code EBI), Class II - Special Controls.

Submitted by Dentsply Intl. (York, US). The FDA issued a Cleared decision on August 12, 1988 after a review of 57 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

FDA 510(k) Submission Details - K882482

510(k) Number K882482 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 16, 1988
Decision Date August 12, 1988
Days to Decision 57 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
70d faster than avg
Panel avg: 127d · This submission: 57d
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 K882482.
PALASEAL(R)
K892452 · Kulzer, Inc. · Jun 1989
DENTURE RESIN
K890830 · G-C Intl. Corp. · May 1989
BASE, DENTURE, RELINING, REPAIRING, REBASING,RESIN
K883799 · Austenal Dental, Inc. · Oct 1988
LIGHT CURE DENTURE GLAZE
K871849 · Austenal Dental, Inc. · Aug 1987
AUSTENAL ACUPAC 20 DENTURE BASE MATERIAL
K863630 · Austenal Dental, Inc. · Mar 1987
AUSTENAL ACUSOFT SOFT LINER
K862557 · Austenal Dental, Inc. · Feb 1987