Cleared Traditional

K962130 - BRANEMARK SYSTEMS MKII SELK-TAPPING FIX...

K962130 is the FDA 510(k) clearance for BRANEMARK SYSTEMS MKII SELK-TAPPING FIX... by Nobelpharma USA, Inc.. It is a Class 2 Dental device (product code DZE) cleared through the Traditional 510(k) pathway after a 49-day FDA review.

K962130 · Nobelpharma USA, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1996
Decision
49d
Days
Class 2
Risk

K962130 is an FDA 510(k) clearance for the BRANEMARK SYSTEMS MKII SELK-TAPPING FIXTURE. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Nobelpharma USA, Inc. (Westmont, US). The FDA issued a Cleared decision on July 22, 1996 after a review of 49 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 Nobelpharma USA, Inc. devices

Submission Details

510(k) Number K962130 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 03, 1996
Decision Date July 22, 1996
Days to Decision 49 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
78d faster than avg
Panel avg: 127d · This submission: 49d
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 674
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K962130.
STERI-OSS APICAL IMPLANT
K960398 · Steri-Oss, Inc. · Aug 1996
3I STND THREADED/SELF TAPPING THREADED/3I MINIPLANT IMPLANTS/3 I EMERGENCE PROF. TEMP. HEALING ABUTMENTS
K960417 · Implant Innovations, Inc. · Aug 1996
STERI-OSS 6 MM DIAMETER HA COATED IMPLANTS
K960886 · Steri-Oss, Inc. · Aug 1996
CERA ONE ABUTMENT SYSTEM
K961737 · Nobelpharma USA, Inc. · Jul 1996
STERI-OSS 6MM DIAMETER TPS COATED IMPLANTS
K961020 · Steri-Oss, Inc. · Jun 1996
SCREW EXTRACTION DEVICE AND THREAD CLEANING TAP
K960979 · Steri-Oss, Inc. · May 1996