Decident

FDA 510(k) K896364 · Nevin Laboratories, Inc.

Substantially Equivalent

510(k) numberK896364

Submission

Device name
Decident
Applicant
Nevin Laboratories, Inc.
Chicago, IL, US
Received
November 6, 1989
Decision date
July 19, 1990
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
EKY – Handpiece, Water-Powered
Device class
Class I (low risk)
Regulation
21 CFR 872.4200
Specialty
Dental

Other 510(k)s with product code EKY

510(k)DeviceApplicantDecision
K123695Traus SIP10EKY · Traditional Saeshin Precision Co., Ltd.12/18/2012SE

Questions and answers

When was Decident cleared by the FDA?

Decident (K896364) received a 510(k) decision of Substantially Equivalent on July 19, 1990, 255 days after the submission was received.

What is the product code of K896364?

The FDA product code is EKY – Handpiece, Water-Powered, a Class I (low risk) device regulated under 21 CFR 872.4200.