Cleared Traditional

K974828 - BRANEMARK SYSTEM EBON(TM) FIXTURE

K974828 is the FDA 510(k) clearance for BRANEMARK SYSTEM EBON(TM) FIXTURE by Nobel Biocare Uas, Inc.. It is a Class 2 Dental device (product code DZE) cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K974828 · Nobel Biocare Uas, Inc. · Dental device
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Mar 1998
Decision
90d
Days
Class 2
Risk

K974828 is an FDA 510(k) clearance for the BRANEMARK SYSTEM(R) EBON(TM) FIXTURE. 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 March 24, 1998 after a review of 90 days - within the typical 510(k) review window.

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 K974828 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 24, 1997
Decision Date March 24, 1998
Days to Decision 90 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
37d faster than avg
Panel avg: 127d · This submission: 90d
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 K974828.
BRANEMARK SYSTEM DEC 600 DRILLING UNIT
K974123 · Nobel Biocare Uas, Inc. · May 1998
ONPLANT ORTHODONTIC SYSTEM
K980460 · Nobel Biocare Uas, Inc. · May 1998
OSSEOTITE DENTAL IMPLANT SYSTEM
K980549 · Implant Innovations, Inc. · Apr 1998
REPLACE CYLINDRICAL IMPLANTS
K980439 · Steri-Oss, Inc. · Mar 1998
IMPLANT SITE DILATORS
K980374 · BioHorizons Implant Systems, Inc. · Mar 1998
STERI-OSS 3.25 MM REPLACE(HYDROXYAPATITE-COATED)DENTAL IMPLANT
K973423 · Steri-Oss, Inc. · Dec 1997