Cleared Traditional

K944964 - BRANEMARK SYSTEM MIRUSCONE ABUTMENT SYSTEM

K944964 is the FDA 510(k) clearance for BRANEMARK SYSTEM MIRUSCONE ABUTMENT SYSTEM by Nobelpharma USA, Inc.. It is a Class 2 Dental device (product code DZE) cleared through the Traditional 510(k) pathway after a 144-day FDA review.

K944964 · Nobelpharma USA, Inc. · Dental device
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Feb 1995
Decision
144d
Days
Class 2
Risk

K944964 is an FDA 510(k) clearance for the BRANEMARK SYSTEM MIRUSCONE ABUTMENT SYSTEM. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Nobelpharma USA, Inc. (Westmont, US). The FDA issued a Cleared decision on February 28, 1995 after a review of 144 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 Nobelpharma USA, Inc. devices

Submission Details

510(k) Number K944964 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 07, 1994
Decision Date February 28, 1995
Days to Decision 144 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
17d slower than avg
Panel avg: 127d · This submission: 144d
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 K944964.
STERI-OSS TITANIUM ALLOY SCREW SERIES IMPLANT FOR SINGLE STAGE SURGICAL PLACEMENT
K944158 · Steri-Oss, Inc. · Mar 1995
BRANEMARK SYSTEM 3.3MM FIXTURE
K944683 · Nobelpharma USA, Inc. · Mar 1995
RESTORE TPS LHEX CYLINDER ENDOSSEOUS IMPLANT SYSTEM
K944069 · Lifecore Biomedical, Inc. · Feb 1995
BRANEMARK SYSTEM 17 ANGULATED ABUTMENT
K944962 · Nobelpharma USA, Inc. · Feb 1995
BRANEMARK SYSTEM SMILINE II
K944963 · Nobelpharma USA, Inc. · Feb 1995
RESTORE SELF TAPPING DENTAL IMPLANT SYST (5, 5.5,6MM)
K944068 · Lifecore Biomedical, Inc. · Feb 1995