Cleared Traditional

K920119 - 3M DENTAL ELECTRONIC ANESTHESIA SYSTEM

K920119 · 3M Company · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 1992
Decision
133d
Days
-
Risk

K920119 is an FDA 510(k) clearance for the 3M DENTAL ELECTRONIC ANESTHESIA SYSTEM. Classified as Device, Electrical Dental Anesthesia (product code LWM).

Submitted by 3M Company (Cottae Grove, US). The FDA issued a Cleared decision on May 22, 1992 after a review of 133 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.

FDA 510(k) Submission Details - K920119

510(k) Number K920119 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 10, 1992
Decision Date May 22, 1992
Days to Decision 133 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
5d slower than avg
Panel avg: 128d · This submission: 133d
Pathway characteristics
Predicate-based equivalence.

LWM Device Classification - Class 0,

Product Code LWM Device, Electrical Dental Anesthesia
Device Class -

Regulatory Peers - LWM Device, Electrical Dental Anesthesia

All 14
Devices cleared under the same product code (LWM) and FDA review panel - the closest regulatory comparables to K920119.
3M DENTAL ELECTRONIC ANESTHESIA (DEA) SYSTEM 8670 MODIFICATION
K935082 · 3M Company · Jan 1994
3M DENTAL ELECTRONONIC ANESTHESIA (DEA0 SYSTEM 8670 ADDITIONAL APPLICATIONS
K935085 · 3M Company · Jan 1994
CEDETA
K915717 · D-W Intl. · Nov 1992
ULTRACALM
K910625 · Sion Technology, Inc. · May 1992
MEDI LISS DENTAL ANALGESIA DEVICE (SBL601)
K900731 · Medical Consultants Intl. , Ltd. · Dec 1990
COMFORTRON II (TENS)
K902948 · M. D. Products · Dec 1990
K920119 · 3M DENTAL ELECTRONIC ANESTHESIA SYSTEM
Download PDF FDA Summary 3M Company