Amalgam Alloy

FDA 510(k) K780997 · Syntex Corp.

Substantially Equivalent

510(k) numberK780997

Submission

Device name
Amalgam Alloy
Applicant
Syntex Corp.
Mchenry, IL, US
Received
June 14, 1978
Decision date
July 27, 1978
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
EJJ – Alloy, Amalgam
Device class
Class II (moderate risk)
Regulation
21 CFR 872.3070
Specialty
Dental

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K002811Ana 70 Non Gamma 2 Dispersed Phase Dental AlloyEJJ · Traditional Nordiska Dental AB10/31/2000SE
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K002808Ana 2000 Non Gamma 2 Extra High Copper Dental AlloyEJJ · Traditional Nordiska Dental AB10/31/2000SE

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Questions and answers

When was Amalgam Alloy cleared by the FDA?

Amalgam Alloy (K780997) received a 510(k) decision of Substantially Equivalent on July 27, 1978, 43 days after the submission was received.

What is the product code of K780997?

The FDA product code is EJJ – Alloy, Amalgam, a Class II (moderate risk) device regulated under 21 CFR 872.3070.