Cleared Traditional

K000018 - BRANEMARK NOVUM

K000018 is the FDA 510(k) clearance for BRANEMARK NOVUM by Nobel Biocare Uas, Inc.. It is a Class 2 Dental device (product code DZE) cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K000018 · Nobel Biocare Uas, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2000
Decision
86d
Days
Class 2
Risk

K000018 is an FDA 510(k) clearance for the BRANEMARK NOVUM. 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 March 30, 2000 after a review of 86 days - a notably fast clearance 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: 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 K000018 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 04, 2000
Decision Date March 30, 2000
Days to Decision 86 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
41d faster than avg
Panel avg: 127d · This submission: 86d
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 K000018.
REPLACE TPS COATED IMPLANTS
K002475 · Nobel Biocare Uas, Inc. · Nov 2000
ITI DENTAL IMPLANT SYSTEM MONOTYPE IMPLANT
K002374 · Straumann USA · Nov 2000
INPLANT ORTHODONTIC ANCHOR SYSTEM
K000643 · Nobel Biocare Uas, Inc. · Sep 2000
SYNOCTA ANGLED ABUTMENTS
K994119 · Straumann USA · Mar 2000
LIFECORE SINGLE TOOTH ABUTMENT SYSTEM
K993894 · Lifecore Biomedical, Inc. · Mar 2000
DENTAL IMPLANT
K992937 · Nobel Biocare Uas, Inc. · Feb 2000