Denti-Tray(Tm)

FDA 510(k) K871493 · Advanced Medical, Inc.

Substantially Equivalent

510(k) numberK871493

Submission

Device name
Denti-Tray(Tm)
Applicant
Advanced Medical, Inc.
Huntington Beach, CA, US
Received
April 16, 1987
Decision date
June 24, 1987
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
EKW – Broach, Endodontic
Device class
Class I (low risk)
Regulation
21 CFR 872.4565
Specialty
Dental

Other 510(k)s with product code EKW

510(k)DeviceApplicantDecision
K870765Cannulated Instrument CleanersEKW · Traditional Treace Medical, Inc.05/27/1987SE
K862523Man Surg Instr/Access Dumbach Titan Mesh Impl SysEKW · Traditional Walter Lorenz Surgical, Inc.08/01/1986SE
K831749Endodontic BROACH(76EKN) Barbed BroachEKW · Traditional Union Branch07/12/1983SE
K823489Endodontic Broach-Barbed BroachEKW · Traditional Union Broach, Div. Moyco Industries, Inc.12/15/1982SE
K800292Endex Broach, EndodonticEKW · Traditional Ipco Corp.02/19/1980SE
K760985Hand InstrumentsEKW · Traditional Adp Intl., Inc.11/15/1976SE

More from Adp Intl., Inc.

510(k)DeviceDecision
K884919Disposable Dome Stock #D-300DRS · Traditional 01/05/1989SE
K760368Monitoring & Stress Testing EquipmentDSI · Traditional 02/28/1977SE

Questions and answers

When was Denti-Tray(Tm) cleared by the FDA?

Denti-Tray(Tm) (K871493) received a 510(k) decision of Substantially Equivalent on June 24, 1987, 69 days after the submission was received.

What is the product code of K871493?

The FDA product code is EKW – Broach, Endodontic, a Class I (low risk) device regulated under 21 CFR 872.4565.