Cleared Traditional

K122972 - CDC ZIRCONIA BLANKS

K122972 is an FDA 510(k) clearance for CDC ZIRCONIA BLANKS, manufactured by Continental Dental Ceramics, Inc. (Dba Continental. The device is a Class 2 Dental device with product code EIH cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K122972 · Continental Dental Ceramics, Inc. (Dba Continental · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2012
Decision
28d
Days
Class 2
Risk

K122972 is an FDA 510(k) clearance for the CDC ZIRCONIA BLANKS. Classified as Powder, Porcelain (product code EIH), Class II - Special Controls.

Submitted by Continental Dental Ceramics, Inc. (Dba Continental (Torrance, US). The FDA issued a Cleared decision on October 24, 2012 after a review of 28 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Continental Dental Ceramics, Inc. (Dba Continental devices

FDA 510(k) Submission Details - K122972

510(k) Number K122972 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 26, 2012
Decision Date October 24, 2012
Days to Decision 28 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
99d faster than avg
Panel avg: 127d · This submission: 28d
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 301
Devices cleared under the same product code (EIH) and FDA review panel - the closest regulatory comparables to K122972.
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