Superstar

FDA 510(k) K930762 · Jelenko Co.

Substantially Equivalent

510(k) numberK930762

Submission

Device name
Superstar
Applicant
Jelenko Co.
Armonk, NY, US
Received
February 12, 1993
Decision date
March 31, 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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More from Dentsply International

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K984164Jelbond NPEJH · Traditional 12/29/1998SE
K964158JEL-40 (Code Name RD-0430)EJT · Traditional 12/13/1996SE
K912195PA-396 Gold Based/Precious Metal Alloys Clin UseEJS · Traditional 07/30/1991SE
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K896915Palladium Based Dental Alloy for Porcelain-MetalEJT · Traditional 04/30/1990SE
K894391PVS Dual Cure Veneer Bonding KitKLE · Traditional 09/19/1989SE
K893688High Noble, Type III Dental Casting AlloyEJT · Traditional 08/23/1989SE
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Questions and answers

When was Superstar cleared by the FDA?

Superstar (K930762) received a 510(k) decision of Substantially Equivalent on March 31, 1993, 47 days after the submission was received.

What is the product code of K930762?

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