Cleared Traditional

CEDETA (K915717) - FDA 510(k) Clearance

K915717 · D-W Intl. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1992
Decision
340d
Days
-
Risk

K915717 is an FDA 510(k) clearance for the CEDETA. Classified as Device, Electrical Dental Anesthesia (product code LWM).

Submitted by D-W Intl. (Vancouver, US). The FDA issued a Cleared decision on November 23, 1992 after a review of 340 days - an unusually long review period, suggesting complex equivalence evaluation.

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. 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 D-W Intl. devices

Submission Details

510(k) Number K915717 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 19, 1991
Decision Date November 23, 1992
Days to Decision 340 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
213d slower than avg
Panel avg: 127d · This submission: 340d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LWM Device, Electrical Dental Anesthesia
Device Class -

Regulatory Peers - LWM Device, Electrical Dental Anesthesia

All 7
Devices cleared under the same product code (LWM) and FDA review panel - the closest regulatory comparables to K915717.
3M DENTAL ELECTRONIC ANESTHESIA (DEA) SYSTEM 8670
K935304 · 3M Company · Mar 1994
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
3M DENTAL ELECTRONIC ANESTHESIA SYSTEM
K920119 · 3M Company · May 1992