Cleared Traditional

K890712 - ADVANTAGE DENTAL CUST DENT IMPRESS/BASEPLATE TRAYS

K890712 is an FDA 510(k) clearance for ADVANTAGE DENTAL CUST DENT IMPRESS/BASE..., manufactured by Advantage Dental Products, Inc.. The device is a Class 1 Dental device with product code EBH cleared through the Traditional 510(k) pathway after a 71-day FDA review.

K890712 · Advantage Dental Products, Inc. · Dental device
Download Printable Device Report (PDF)
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Apr 1989
Decision
71d
Days
Class 1
Risk

K890712 is an FDA 510(k) clearance for the ADVANTAGE DENTAL CUST DENT IMPRESS/BASEPLATE TRAYS. Classified as Material, Impression Tray, Resin (product code EBH), Class I - General Controls.

Submitted by Advantage Dental Products, Inc. (Auburn Hills, US). The FDA issued a Cleared decision on April 25, 1989 after a review of 71 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3670 - 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.

FDA 510(k) Submission Details - K890712

510(k) Number K890712 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 13, 1989
Decision Date April 25, 1989
Days to Decision 71 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
57d faster than avg
Panel avg: 128d · This submission: 71d
Pathway characteristics
Predicate-based equivalence.

EBH Device Classification - Class 1, General Controls

Product Code EBH Material, Impression Tray, Resin
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.3670
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - EBH Material, Impression Tray, Resin

All 29
Devices cleared under the same product code (EBH) and FDA review panel - the closest regulatory comparables to K890712.
PALAVIT L
K905058 · Kulzer, Inc. · Jun 1991
PALATRAY LC RESIN IMPRESSION TRAY MATERIAL
K902350 · Kulzer, Inc. · Jul 1990
CONVERTRAY CUSTOM IMPRESSION TRAY MATERIAL SYSTEM
K901782 · Productivity Training Corp. · Jun 1990
MODIFIED PERMAGUM ADHESIVE
K881838 · Espe GmbH (Us) · Jul 1988
PERMADYNE ADHESIVE
K875228 · Espe GmbH (Us) · Mar 1988
IMPREGUM F ADHESIVE
K875257 · Espe GmbH (Us) · Mar 1988
K890712 · ADVANTAGE DENTAL CUST DENT IMPRESS/BASEPLATE TRAYS
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