Degussa Stopfgold (Degussa Direct-Filling Gold)
FDA 510(k) K902387 · Degussa AG
510(k) numberK902387
Submission
- Device name
- Degussa Stopfgold (Degussa Direct-Filling Gold)
- Applicant
- Degussa AG
West Germany, DE - Received
- May 30, 1990
- Decision date
- June 28, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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| K955027 | Degubond X-LiteEJT · Traditional | 12/01/1995SE |
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Questions and answers
When was Degussa Stopfgold (Degussa Direct-Filling Gold) cleared by the FDA?
Degussa Stopfgold (Degussa Direct-Filling Gold) (K902387) received a 510(k) decision of Substantially Equivalent on June 28, 1990, 29 days after the submission was received.
What is the product code of K902387?
The FDA product code is EJT – Alloy, Gold-Based Noble Metal, a Class II (moderate risk) device regulated under 21 CFR 872.3060.