Cleared Traditional

K911960 - BRANEMARK SYSTEM-3.0MM FIXTURE

K911960 is an FDA 510(k) clearance for BRANEMARK SYSTEM-3.0MM FIXTURE, 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 231-day FDA review.

K911960 · Nobelpharma USA, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1991
Decision
231d
Days
Class 2
Risk

K911960 is an FDA 510(k) clearance for the BRANEMARK SYSTEM-3.0MM 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 December 19, 1991 after a review of 231 days - an extended review 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: 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 Nobelpharma USA, Inc. devices

FDA 510(k) Submission Details - K911960

510(k) Number K911960 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 02, 1991
Decision Date December 19, 1991
Days to Decision 231 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
104d slower than avg
Panel avg: 127d · This submission: 231d
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 K911960.
BUR,DENTAL (76EJL)
K915597 · Calcitek, Inc. · Feb 1992
DPI-1106 IMPLANT, MODIFICATION
K911776 · Minimatic Implant Technology · Jan 1992
INTERPORE HEX HEAD IMPLANT RESTORATIVE COMPONENTS
K912734 · Interpore Intl. · Jan 1992
HEXLOCK
K912262 · Imtec Corp. · Dec 1991
VIDENT IMPAC IMPLANT ACCESSORIES
K904391 · Vident · Dec 1991
TCAL ABUTMENT
K913782 · Core-Vent Corp. · Oct 1991