Cleared Traditional

HAND TOOLS FOR ARTECH TYPE SS SUBMERGED SCREW IMPL (K894160) - FDA 510(k) Clearance

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

K894160 · Artech Corp. · Dental device
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Sep 1989
Decision
106d
Days
Class 2
Risk

K894160 is an FDA 510(k) clearance for the HAND TOOLS FOR ARTECH TYPE SS SUBMERGED SCREW IMPL. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Artech Corp. (Chantilly, US). The FDA issued a Cleared decision on September 28, 1989 after a review of 106 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 Artech Corp. devices

Submission Details

510(k) Number K894160 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 14, 1989
Decision Date September 28, 1989
Days to Decision 106 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
21d faster than avg
Panel avg: 127d · This submission: 106d
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.