Cleared Traditional

K974828 - BRANEMARK SYSTEM(R) EBON(TM) FIXTURE

K974828 is an FDA 510(k) clearance for BRANEMARK SYSTEM EBON(TM) FIXTURE, 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 90-day FDA review.

K974828 · Nobel Biocare Uas, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K974828

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.

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 1244
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K974828.
ONPLANT ORTHODONTIC SYSTEM
K980460 · Nobel Biocare Uas, Inc. · May 1998
OSSEOTITE DENTAL IMPLANT SYSTEM
K980549 · Implant Innovations, Inc. · Apr 1998
ASTRA TECH IMPLANT DENTAL SYSTEM
K974737 · Astra Tech, Inc. · Mar 1998
ASTRA TECH IMPLANTS - DENTAL SYSTEM
K980698 · Astra Tech, Inc. · Mar 1998
REPLACE CYLINDRICAL IMPLANTS
K980439 · Steri-Oss, Inc. · Mar 1998
CRYSTAL AND CRYSTAL-SEAL IMPLANTS SYSTEM
K980442 · Crystal Medical Technology · Mar 1998