Cleared Traditional

IMPLA-MED UCLA TYPE ABUTMENTS,SCREWDRIVER,REAMER,L (K933193) - FDA 510(k) Clearance

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K933193 · The Stern Metals Co., Inc. · Dental device
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Mar 1994
Decision
250d
Days
Class 2
Risk

K933193 is an FDA 510(k) clearance for the IMPLA-MED UCLA TYPE ABUTMENTS,SCREWDRIVER,REAMER,L. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by The Stern Metals Co., Inc. (Attleboro, US). The FDA issued a Cleared decision on March 7, 1994 after a review of 250 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 The Stern Metals Co., Inc. devices

Submission Details

510(k) Number K933193 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 30, 1993
Decision Date March 07, 1994
Days to Decision 250 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
123d slower than avg
Panel avg: 127d · This submission: 250d
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.