Cleared Traditional

K150432 - IDODENTINE DISC, IDODENTINE BLOCK

K150432 is an FDA 510(k) clearance for IDODENTINE DISC, manufactured by Union Dental S.A.. The device is a Class 2 Dental device with product code EBG cleared through the Traditional 510(k) pathway after a 176-day FDA review.

K150432 · Union Dental S.A. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2015
Decision
176d
Days
Class 2
Risk

K150432 is an FDA 510(k) clearance for the IDODENTINE DISC, IDODENTINE BLOCK. Classified as Crown And Bridge, Temporary, Resin (product code EBG), Class II - Special Controls.

Submitted by Union Dental S.A. (Tielmes, ES). The FDA issued a Cleared decision on August 14, 2015 after a review of 176 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3770 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K150432

510(k) Number K150432 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 19, 2015
Decision Date August 14, 2015
Days to Decision 176 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
48d slower than avg
Panel avg: 128d · This submission: 176d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EBG Device Classification - Class 2, Special Controls

Product Code EBG Crown And Bridge, Temporary, Resin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3770
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 - EBG Crown And Bridge, Temporary, Resin

All 174
Devices cleared under the same product code (EBG) and FDA review panel - the closest regulatory comparables to K150432.
DENTALOS PLUS MONO, DENTALOS PLUS MULTICOLOR
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TIZIAN BLANK, TIZIAN ZIRCONIUM REINFORCED COMPOSITE BLANK, TIZIAN COLOR BLANK, TIZIAN BLANK OCCLUSAL, TIZIAN BLANK TRANS
K133268 · Schutz-Dental GmbH · Feb 2015
PMMA BLOCK
K141421 · Rizhao Huge Dental Industry Co., Ltd. · Feb 2015