Cleared Traditional

K000018 - BRANEMARK NOVUM

K000018 is an FDA 510(k) clearance for BRANEMARK NOVUM, manufactured by Nobel Biocare Uas, Inc.. The device is a Class 2 Dental device with 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

FDA 510(k) Submission Details - K000018

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.

DZE Device Classification - Class 2, Special Controls

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 1243
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K000018.
SWISSPLUS IMPLANT SYSTEM, MODEL SPWB 8,10,12,14/OPH20/SMPR, SPB 8,10,12,14/OP3.5D/OPAR,OPB 8,10,12,14/OP2.3D/OP2.8D,
K002188 · Core-Vent Corp. · Oct 2000
INPLANT ORTHODONTIC ANCHOR SYSTEM
K000643 · Nobel Biocare Uas, Inc. · Sep 2000
FRIALIT-2 MH-2 ABUTMENT
K994174 · Friadent GmbH · Apr 2000
UCLA/UNIVERSAL ABUTMENT
K993129 · Diamodent · Mar 2000
FRIALIT-2 3.4MM STEEPED CYLINDER IMPLANT WITH FRIOS TPS COATING
K994376 · Friadent GmbH · Mar 2000
SYNOCTA ANGLED ABUTMENTS
K994119 · Straumann USA · Mar 2000