Cleared Traditional

3M DENTAL ELECTRONIC ANESTHESIA (DEA) SYSTEM 8670 MODIFICATION (K935082) - FDA 510(k) Clearance

K935082 · 3M Company · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1994
Decision
96d
Days
-
Risk

K935082 is an FDA 510(k) clearance for the 3M DENTAL ELECTRONIC ANESTHESIA (DEA) SYSTEM 8670 MODIFICATION. Classified as Device, Electrical Dental Anesthesia (product code LWM).

Submitted by 3M Company (St. Paul, US). The FDA issued a Cleared decision on January 26, 1994 after a review of 96 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel. 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.

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Submission Details

510(k) Number K935082 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 22, 1993
Decision Date January 26, 1994
Days to Decision 96 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
31d faster than avg
Panel avg: 127d · This submission: 96d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LWM Device, Electrical Dental Anesthesia
Device Class -

Regulatory Peers - LWM Device, Electrical Dental Anesthesia

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