Cleared Traditional

BREDENT NOVO.LIGN A/ BREDENT NOVO.LIGN P (K101064) - FDA 510(k) Clearance

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

K101064 · Bredent GmbH & Co. KG · Dental device
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Sep 2010
Decision
151d
Days
Class 2
Risk

K101064 is an FDA 510(k) clearance for the BREDENT NOVO.LIGN A/ BREDENT NOVO.LIGN P. Classified as Denture, Plastic, Teeth (product code ELM), Class II - Special Controls.

Submitted by Bredent GmbH & Co. KG (Tuttlingen, Baden Wurttemberg, DE). The FDA issued a Cleared decision on September 14, 2010 after a review of 151 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3590 - 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 Bredent GmbH & Co. KG devices

Submission Details

510(k) Number K101064 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 16, 2010
Decision Date September 14, 2010
Days to Decision 151 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
24d slower than avg
Panel avg: 127d · This submission: 151d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code ELM Denture, Plastic, Teeth
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3590
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 - ELM Denture, Plastic, Teeth

All 8
Devices cleared under the same product code (ELM) and FDA review panel - the closest regulatory comparables to K101064.
MONDIAL
K060994 · Heraeus Kulzer, Inc. · May 2006
ARTIC
K033628 · Heraeus Kulzer, Inc. · Jan 2004
PREMIUM
K011130 · Heraeus Kulzer, Inc. · Jul 2001
SR ANTARIS ANTERIOR TEETH/SR POSTARIS POSTERIOR TEETH
K962456 · Ivoclar North America, Inc. · Aug 1996
NEW TOOTH MATERIAL
K920684 · Dentsply Intl. · Dec 1992
DELTA TEETH
K831214 · Dentsply Intl. · May 1983