Cleared Traditional

K100150 - CERAMICS2IN1 (FDA 510(k) Clearance)

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K100150 · Biodenta Swiss AG · Dental device
Download Printable Device Report (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.

View all Biodenta Swiss AG devices

Submission Details

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
1d faster than avg
Panel avg: 127d · This submission: 126d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 478
Devices cleared under the same product code (EIH) and FDA review panel - the closest regulatory comparables to K100150.
Eternal Art Porcelain Powders
K260067 · Shandong Huge Dental Material Corporation · Apr 2026
IPS e.max Zirconia
K253953 · Ivoclar Vivadent, Inc. · Mar 2026
BruxZir® Shaded 16 PLUS
K254283 · Prismatik Dentalcraft, Inc. · Jan 2026
Gradual Dental Zirconia Blank - GT(F) P1, GT(F) P2, and SP Series
K253973 · Liaoning Upcera Co., Ltd. · Jan 2026
Glass Ceramic
K252789 · Shenzhen Xiangtong Co., Ltd. · Dec 2025
BruxZir® NOW
K252446 · Prismatik Dentalcraft, Inc. · Sep 2025