Cleared Traditional

K071010 - TIZIAN CERAMIC, FLOW, PLATE, FIX & ZR BLANKS

K071010 is an FDA 510(k) clearance for TIZIAN CERAMIC, manufactured by Schutz-Dental GmbH. The device is a Class 2 Dental device with product code EIH cleared through the Traditional 510(k) pathway after a 137-day FDA review.

K071010 · Schutz-Dental GmbH · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2007
Decision
137d
Days
Class 2
Risk

K071010 is an FDA 510(k) clearance for the TIZIAN CERAMIC, FLOW, PLATE, FIX & ZR BLANKS. Classified as Powder, Porcelain (product code EIH), Class II - Special Controls.

Submitted by Schutz-Dental GmbH (Rosbach, DE). The FDA issued a Cleared decision on August 24, 2007 after a review of 137 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 - K071010

510(k) Number K071010 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 09, 2007
Decision Date August 24, 2007
Days to Decision 137 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
9d slower than avg
Panel avg: 128d · This submission: 137d
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 K071010.
ZENO ZR DISC
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GC-ZIRCONIA
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K071201 · Xpdent Corp · Jul 2007