Cleared Traditional

K970499 - BRANEMARK SYSTEM ZYGOMATICUS FIXTURE SY...

K970499 is the FDA 510(k) clearance for BRANEMARK SYSTEM ZYGOMATICUS FIXTURE SY... by Nobel Biocare Uas, Inc.. It is a Class 2 Dental device (product code DZE) cleared through the Traditional 510(k) pathway after a 248-day FDA review.

K970499 · Nobel Biocare Uas, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1997
Decision
248d
Days
Class 2
Risk

K970499 is an FDA 510(k) clearance for the BRANEMARK SYSTEM ZYGOMATICUS FIXTURE SYSTEM. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Nobel Biocare Uas, Inc. (Westmont, US). The FDA issued a Cleared decision on October 16, 1997 after a review of 248 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 K970499 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 10, 1997
Decision Date October 16, 1997
Days to Decision 248 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
121d slower than avg
Panel avg: 127d · This submission: 248d
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 K970499.
DENTAL/SURGICAL DRILLS, BURS, TAPS
K973771 · Implant Innovations, Inc. · Dec 1997
BONDING BASE
K973353 · Straumann USA · Dec 1997
STERI-OSS 3.25 MM REPLACE DENTAL IMPLANT SYSTEM
K973402 · Steri-Oss, Inc. · Nov 1997
THE MAESTRO SYSTEM
K972313 · BioHorizons Implant Systems, Inc. · Sep 1997
3I INNOVATIVE IMPLANTS AND COVER SCREWS
K972444 · Implant Innovations, Inc. · Aug 1997
ENDOSSEOUS DENTAL IMPLANT
K971578 · Straumann USA · Jun 1997