Cleared Traditional

K000643 - INPLANT ORTHODONTIC ANCHOR SYSTEM

K000643 is the FDA 510(k) clearance for INPLANT ORTHODONTIC ANCHOR SYSTEM by Nobel Biocare Uas, Inc.. It is a Class 2 Dental device (product code DZE) cleared through the Traditional 510(k) pathway after a 195-day FDA review.

K000643 · Nobel Biocare Uas, Inc. · Dental device
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Optimized for regulatory review, auditing and printing
Sep 2000
Decision
195d
Days
Class 2
Risk

K000643 is an FDA 510(k) clearance for the INPLANT ORTHODONTIC ANCHOR SYSTEM. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Nobel Biocare Uas, Inc. (Yorba Linda, US). The FDA issued a Cleared decision on September 7, 2000 after a review of 195 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3640 - 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 Nobel Biocare Uas, Inc. devices

Submission Details

510(k) Number K000643 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 25, 2000
Decision Date September 07, 2000
Days to Decision 195 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
68d slower than avg
Panel avg: 127d · This submission: 195d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DZE Implant, Endosseous, Root-form
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3640
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 - DZE Implant, Endosseous, Root-form

All 672
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K000643.
THE LIFECORE STAGE-1 SINGLE STAGE RBM DENTAL IMPLANT SYSTEM
K003226 · Lifecore Biomedical, Inc. · Jan 2001
REPLACE TPS COATED IMPLANTS
K002475 · Nobel Biocare Uas, Inc. · Nov 2000
ITI DENTAL IMPLANT SYSTEM MONOTYPE IMPLANT
K002374 · Straumann USA · Nov 2000
BRANEMARK NOVUM
K000018 · Nobel Biocare Uas, Inc. · Mar 2000
SYNOCTA ANGLED ABUTMENTS
K994119 · Straumann USA · Mar 2000
LIFECORE SINGLE TOOTH ABUTMENT SYSTEM
K993894 · Lifecore Biomedical, Inc. · Mar 2000