Cleared Traditional

K023722 - SAFETYWAND DISPOSABLE HANDPIECE (FDA 510(k) Clearance)

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

K023722 · Spintech, Inc. · Dental device
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Sep 2003
Decision
301d
Days
Class 2
Risk

K023722 is an FDA 510(k) clearance for the SAFETYWAND DISPOSABLE HANDPIECE. Classified as Syringe, Cartridge (product code EJI), Class II - Special Controls.

Submitted by Spintech, Inc. (Washington, US). The FDA issued a Cleared decision on September 2, 2003 after a review of 301 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6770 - 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. Elevated predicate reliance profile. 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 Spintech, Inc. devices

Submission Details

510(k) Number K023722 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 05, 2002
Decision Date September 02, 2003
Days to Decision 301 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
174d slower than avg
Panel avg: 127d · This submission: 301d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EJI Syringe, Cartridge
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.6770
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.