285 SL

FDA 510(k) K961352 · Argen Precious Metals, Inc.

Substantially Equivalent

510(k) numberK961352

Submission

Device name
285 SL
Applicant
Argen Precious Metals, Inc.
San Diego, CA, US
Received
April 8, 1996
Decision date
May 20, 1996
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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Questions and answers

When was 285 SL cleared by the FDA?

285 SL (K961352) received a 510(k) decision of Substantially Equivalent on May 20, 1996, 42 days after the submission was received.

What is the product code of K961352?

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