Cleared Traditional

K946198 - IMPLA-MED LOW MARGIN ABUTMENTS, SCREWDRIVER, POLISHING PROTECTOR

K946198 is an FDA 510(k) clearance for IMPLA-MED LOW MARGIN ABUTMENTS, manufactured by Sterngold. The device is a Class 2 Dental device with product code DZE cleared through the Traditional 510(k) pathway after a 176-day FDA review.

K946198 · Sterngold · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 1995
Decision
176d
Days
Class 2
Risk

K946198 is an FDA 510(k) clearance for the IMPLA-MED LOW MARGIN ABUTMENTS, SCREWDRIVER, POLISHING PROTECTOR. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Sterngold (Sunrise, US). The FDA issued a Cleared decision on June 14, 1995 after a review of 176 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.

FDA 510(k) Submission Details - K946198

510(k) Number K946198 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 20, 1994
Decision Date June 14, 1995
Days to Decision 176 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
48d slower than avg
Panel avg: 128d · This submission: 176d
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 1500
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K946198.
TORQUE LIMITER
K952120 · Steri-Oss, Inc. · Jun 1995
3.3MM ACCESSORIES
K952448 · Nobelpharma USA, Inc. · Jun 1995
ITI ANGLED ABUTMENT
K941393 · The Straumann Co. · Jun 1995
SURGICAL INSTRUMENT MOTOTRS AND ACCESSORIES/ATTACHMENTS
K951065 · Steri-Oss, Inc. · Jun 1995
BIOPATH SELF-TAPPING DENTAL IMPLANT SYSTEM (5MM, 6MM)
K951937 · Bio Path · Jun 1995
OSTEOTOMES
K952193 · Steri-Oss, Inc. · Jun 1995
K946198 · IMPLA-MED LOW MARGIN ABUTMENTS, SCREWDRIVER, POLISHING PROTECTOR
Download PDF FDA Summary Sterngold