Wil-Pds & Wil-Pdi Casting Alloys

FDA 510(k) K915250 · Wilde-USA, Inc.

Substantially Equivalent

510(k) numberK915250

Submission

Device name
Wil-Pds & Wil-Pdi Casting Alloys
Applicant
Wilde-USA, Inc.
Chicago, IL, US
Received
November 15, 1991
Decision date
April 21, 1992
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
EJH – Alloy, Metal, Base
Device class
Class II (moderate risk)
Regulation
21 CFR 872.3710
Specialty
Dental

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K040179ContinumEJH · Traditional Aalba Dent, Inc.03/03/2004SE
K033356Verasoft EsEJH · Traditional Aalba Dent, Inc.12/30/2003SE
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K032136Wirobond CEJH · Traditional Bego U.S.A.09/04/2003SE
K031627Nano-TicrownEJH · Traditional Nano-Write Corp.06/11/2003SE
K030632PD Casta-HEJH · Traditional Mountain Medico, Inc.05/07/2003SE
K030416Ceracast-VEJH · Traditional Mountain Medico, Inc.04/14/2003SE
K030161SuperbondEJH · Traditional American Dent-All, Inc.03/17/2003SE

More from American Dent-All, Inc.

510(k)DeviceDecision
K913582Compatit RELM · Traditional 06/24/1993SE
K915653KeramailEIH · Traditional 04/08/1993SE
K913581Wilde Adhesive Bonding SystemKLE · Traditional 02/26/1993SE
K923472CompacolorEBF · Traditional 10/13/1992SE
K920649CompasepFMC · Traditional 07/23/1992SE
K913089Wilde Light Curing Composite Restorative ResinsEBF · Traditional 04/21/1992SE
K912990ConverbaseEBI · Traditional 03/25/1992SE
K920557Wil-O-Dont Orthodontic Material/Wil-O-LuxEBI · Traditional 03/20/1992SE
K915654Keralloy-D CapsEJJ · Traditional 03/02/1992SE
K912993Wilde Denture ResinsEBI · Traditional 02/03/1992SE

Questions and answers

When was Wil-Pds & Wil-Pdi Casting Alloys cleared by the FDA?

Wil-Pds & Wil-Pdi Casting Alloys (K915250) received a 510(k) decision of Substantially Equivalent on April 21, 1992, 158 days after the submission was received.

What is the product code of K915250?

The FDA product code is EJH – Alloy, Metal, Base, a Class II (moderate risk) device regulated under 21 CFR 872.3710.