Suncast

FDA 510(k) K923720 · J.F. Jelenko & Co., Inc.

Substantially Equivalent

510(k) numberK923720

Submission

Device name
Suncast
Applicant
J.F. Jelenko & Co., Inc.
Armonk, NY, US
Received
July 27, 1992
Decision date
March 5, 1993
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
EJT – Alloy, Gold-Based Noble Metal
Device class
Class II (moderate risk)
Regulation
21 CFR 872.3060
Specialty
Dental

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K033279Gold Dental Casting AlloysEJT · Traditional Bego U.S.A.01/15/2004SE
K033446APEX93, APEX87, APEX84, APEX85, APEX77, E-Sarang 88 and E-Sarang 82EJT · Traditional We Dong Myung Dental Industrial Co., Ltd.11/13/2003SE
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Questions and answers

When was Suncast cleared by the FDA?

Suncast (K923720) received a 510(k) decision of Substantially Equivalent on March 5, 1993, 221 days after the submission was received.

What is the product code of K923720?

The FDA product code is EJT – Alloy, Gold-Based Noble Metal, a Class II (moderate risk) device regulated under 21 CFR 872.3060.