Cleared Traditional

K925760 - BRANEMARK SYSTEM CONICAL SELF-TAPPING FIXTURE

K925760 is an FDA 510(k) clearance for BRANEMARK SYSTEM CONICAL SELF-TAPPING F..., manufactured by Nobelpharma USA, Inc.. The device is a Class 2 Dental device with 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

FDA 510(k) Submission Details - K925760

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.

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 1265
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