Cleared Traditional

K100150 - CERAMICS2IN1

K100150 is an FDA 510(k) clearance for CERAMICS2IN1, manufactured by Biodenta Swiss AG. The device is a Class 2 Dental device with product code EIH cleared through the Traditional 510(k) pathway after a 126-day FDA review.

K100150 · Biodenta Swiss AG · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2010
Decision
126d
Days
Class 2
Risk

K100150 is an FDA 510(k) clearance for the CERAMICS2IN1. Classified as Powder, Porcelain (product code EIH), Class II - Special Controls.

Submitted by Biodenta Swiss AG (Berneck, St.Gallen, CH). The FDA issued a Cleared decision on May 25, 2010 after a review of 126 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6660 - 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 - K100150

510(k) Number K100150 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 19, 2010
Decision Date May 25, 2010
Days to Decision 126 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
2d faster than avg
Panel avg: 128d · This submission: 126d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EIH Device Classification - Class 2, Special Controls

Product Code EIH Powder, Porcelain
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.6660
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 - EIH Powder, Porcelain

All 471
Devices cleared under the same product code (EIH) and FDA review panel - the closest regulatory comparables to K100150.
NOBELPROCERA IPS E.MAX CROWN
K100512 · Nobel Biocare AB · Aug 2010
VITABLOCS
K102128 · Vita Zahnfabrik H.Rauter GmbH & Co. · Aug 2010
OBSIDIAN CERAMIC BLOCKS
K100781 · Prismatik Dentalcraft, Inc. · Jun 2010
LUMINESSE ZR BLANKS
K100232 · Talladium, Inc. · May 2010
A&E ZIRCONIA BLANKS MODEL EZBUCT02, EZBUCT04, EZBUCT25, EZBUCT31, EZBUST07, EZBUST08, EZBUTT05, EZBUTT06
K100145 · A&E Bioceramic Co., Ltd. · Apr 2010
XCERAM
K100250 · Xceramusa · Apr 2010