Cleared Traditional

K925760 - BRANEMARK SYSTEM CONICAL SELF-TAPPING F...

K925760 is the FDA 510(k) clearance for BRANEMARK SYSTEM CONICAL SELF-TAPPING F... by Nobelpharma USA, Inc.. It is a Class 2 Dental device (product code DZE) cleared through the Traditional 510(k) pathway after a 326-day FDA review.

K925760 · Nobelpharma USA, Inc. · Dental device
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Oct 1993
Decision
326d
Days
Class 2
Risk

K925760 is an FDA 510(k) clearance for the BRANEMARK SYSTEM CONICAL SELF-TAPPING FIXTURE. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Nobelpharma USA, Inc. (Chicago, US). The FDA issued a Cleared decision on October 5, 1993 after a review of 326 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Nobelpharma USA, Inc. devices

Submission Details

510(k) Number K925760 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 1992
Decision Date October 05, 1993
Days to Decision 326 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
199d slower than avg
Panel avg: 127d · This submission: 326d
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 K925760.
NOBLEPHARMA BRANEMARK SYSTEM GOLD CYLINDERS
K925487 · Nobelpharma USA, Inc. · Oct 1993
BRANEMARK SYSTEM SELF-TAPPING FIXTURE
K925762 · Nobelpharma USA, Inc. · Oct 1993
STERI-OSS DUAL COATED CYLINDRICAL IMPLANTS
K911593 · Steri-Oss, Inc. · Oct 1993
BRANEMARK SYSTEM 5.0 X 14MM FIXTURE
K925761 · Nobelpharma USA, Inc. · Oct 1993
BRANEMARK SYSTEM 4.00 MM FIXTURE
K925764 · Nobelpharma USA, Inc. · Oct 1993
BRANEMARK SYSTEM STANDARD 3.75MM FIXTURE
K925765 · Nobelpharma USA, Inc. · Oct 1993