Cleared Traditional

K952685 - BRANEMARK SYSTEM DRILLS AND COUNTERSINKS

K952685 is the FDA 510(k) clearance for BRANEMARK SYSTEM DRILLS AND COUNTERSINKS by Nobelpharma USA, Inc.. It is a Class 2 Dental device (product code DZE) cleared through the Traditional 510(k) pathway after a 98-day FDA review.

K952685 · Nobelpharma USA, Inc. · Dental device
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Sep 1995
Decision
98d
Days
Class 2
Risk

K952685 is an FDA 510(k) clearance for the BRANEMARK SYSTEM DRILLS AND COUNTERSINKS. 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 September 18, 1995 after a review of 98 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 K952685 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 12, 1995
Decision Date September 18, 1995
Days to Decision 98 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
29d faster than avg
Panel avg: 127d · This submission: 98d
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 673
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K952685.
BRANEMARK RESTORATIVE INSTRUMENT & COMPONENT TRAY
K953774 · Nobelpharma USA, Inc. · Sep 1995
BRANDEMARK ACCESSORIES TO CERAMIC ABUTYMENT (CERAMICORE)
K953775 · Nobelpharma USA, Inc. · Sep 1995
ABUTMENT
K953836 · Steri-Oss, Inc. · Sep 1995
BRANEMARK SYSTEM OVOID & U-SHAPED BAR SYSTEM
K952886 · Nobelpharma USA, Inc. · Sep 1995
COMBINATION KIT
K953331 · Steri-Oss, Inc. · Sep 1995
LABORATORY SUPPLIES
K953380 · Steri-Oss, Inc. · Sep 1995