Olympia Alloy

FDA 510(k) K881333 · J.F. Jelenko & Co., Inc.

Substantially Equivalent

510(k) numberK881333

Submission

Device name
Olympia Alloy
Applicant
J.F. Jelenko & Co., Inc.
Armonk, NY, US
Received
March 29, 1988
Decision date
April 21, 1988
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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K032152Benco AdmixEJJ · Traditional Southern Dental Industries, Inc.08/06/2003SE
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K011801Futura Topcap Non GAMMA-2EJJ · Traditional Ab Ardent08/16/2001SE
K002811Ana 70 Non Gamma 2 Dispersed Phase Dental AlloyEJJ · Traditional Nordiska Dental AB10/31/2000SE
K002810Ana 3000 SM Non Gamma 2 Modified Spherical Dental AlloyEJJ · Traditional Nordiska Dental AB10/31/2000SE
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 Olympia Alloy cleared by the FDA?

Olympia Alloy (K881333) received a 510(k) decision of Substantially Equivalent on April 21, 1988, 23 days after the submission was received.

What is the product code of K881333?

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