Cedeta

FDA 510(k) K915717 · D-W Intl.

Substantially Equivalent

510(k) numberK915717

Submission

Device name
Cedeta
Applicant
D-W Intl.
Vancouver, WA, US
Received
December 19, 1991
Decision date
November 23, 1992
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
LWM – Device, Electrical Dental Anesthesia
Device class
Unclassified

Other 510(k)s with product code LWM

510(k)DeviceApplicantDecision
K193570Dental Pain EraserLWM · Special Synapse Dental01/17/2020SE
K192429Dental Pain EraserLWM · Traditional Synapse Dental01/14/2020SE
K182947Dental Pain EraserLWM · Traditional Synapse Dental, LLC03/26/2019SE
K011001Team-Up TM Dental Electronic Anesthesia SystemLWM · Traditional Satelec06/07/2001SE
K9353043M Dental Electronic Anesthesia (Dea) System 8670LWM · Traditional 3M Company03/16/1994SE
K9350853M Dental Electrononic Anesthesia (DEA0 System 8670 Additional ApplicationsLWM · Traditional 3M Company01/26/1994SE
K9350823M Dental Electronic Anesthesia (Dea) System 8670 ModificationLWM · Traditional 3M Company01/26/1994SE
K9201193M Dental Electronic Anesthesia SystemLWM · Traditional 3M Company05/22/1992SE
K910625UltracalmLWM · Traditional Sion Technology, Inc.05/15/1992SE
K902948Comfortron II (TENS)LWM · Traditional M. D. Products12/17/1990SE

Questions and answers

When was Cedeta cleared by the FDA?

Cedeta (K915717) received a 510(k) decision of Substantially Equivalent on November 23, 1992, 340 days after the submission was received.

What is the product code of K915717?

The FDA product code is LWM – Device, Electrical Dental Anesthesia, a Unclassified device.