Cleared Traditional

K041312 - NOBELRONDO DENTAL CERAMIC-ALUMINA

K041312 is the FDA 510(k) clearance for NOBELRONDO DENTAL CERAMIC-ALUMINA by Nobel Biocare Uas, Inc.. It is a Class 2 Dental device (product code EIH) cleared through the Traditional 510(k) pathway after a 67-day FDA review.

K041312 · Nobel Biocare Uas, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2004
Decision
67d
Days
Class 2
Risk

K041312 is an FDA 510(k) clearance for the NOBELRONDO DENTAL CERAMIC-ALUMINA. Classified as Powder, Porcelain (product code EIH), Class II - Special Controls.

Submitted by Nobel Biocare Uas, Inc. (Yorba Linda,, US). The FDA issued a Cleared decision on July 23, 2004 after a review of 67 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 Nobel Biocare Uas, Inc. devices

Submission Details

510(k) Number K041312 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 17, 2004
Decision Date July 23, 2004
Days to Decision 67 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
60d faster than avg
Panel avg: 127d · This submission: 67d
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 275
Devices cleared under the same product code (EIH) and FDA review panel - the closest regulatory comparables to K041312.
ALLUX
K050203 · Wieland Dental + Technik GmbH & Co. KG · Feb 2005
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HERACERAM PRESS
K040859 · Heraeus Kulzer, Inc. · May 2004
GC INITIAL MC, AL AND LF
K040567 · GC America, Inc. · Apr 2004
CARRARA INTERACTION CERAMIC SYSTEM
K040635 · Dentsply Intl. · Mar 2004