Cleared Traditional

K945398 - BRANEMARK SYSTEM(R) MKII SELF-TAPPING FIXTURE

K945398 is an FDA 510(k) clearance for BRANEMARK SYSTEM MKII SELF-TAPPING 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 161-day FDA review.

K945398 · Nobelpharma USA, Inc. · Dental device
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Apr 1995
Decision
161d
Days
Class 2
Risk

K945398 is an FDA 510(k) clearance for the BRANEMARK SYSTEM(R) MKII SELF-TAPPING FIXTURE. 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 April 13, 1995 after a review of 161 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 - K945398

510(k) Number K945398 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 03, 1994
Decision Date April 13, 1995
Days to Decision 161 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
34d slower than avg
Panel avg: 127d · This submission: 161d
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 K945398.
KIS-II STR FIXTURES
K944725 · Implant Center of the Palm Beaches · Apr 1995
BONE CUTTING INSTRUMENT AND ACCESSORIES
K950936 · Steri-Oss, Inc. · Apr 1995
STERI-OSS SCALER FOR DENTAL IMPLANTS
K943681 · Steri-Oss, Inc. · Apr 1995
RESTORE SELF TAPPING DENTAL IMPLANT SYSTEM (3.4MM)
K951111 · Lifecore Biomedical, Inc. · Mar 1995
STERI-OSS TITANIUM ALLOY SCREW SERIES IMPLANT FOR SINGLE STAGE SURGICAL PLACEMENT
K944158 · Steri-Oss, Inc. · Mar 1995
3I STANDARD THREADED/SELF-TAPPING THREADED IMPLANTS MODIFICATION
K935544 · Implant Innovations International, Inc. · Mar 1995