LC Microhybrid
FDA 510(k) K984484 · S & C Polymer GmbH
510(k) numberK984484
Submission
- Device name
- LC Microhybrid
- Applicant
- S & C Polymer GmbH
Elmshorn, DE - Received
- December 16, 1998
- Decision date
- January 20, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K031420 | S & C -Bracket AdhesivesDYH · Traditional | 08/20/2003SE |
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Questions and answers
When was LC Microhybrid cleared by the FDA?
LC Microhybrid (K984484) received a 510(k) decision of Substantially Equivalent on January 20, 1999, 35 days after the submission was received.
What is the product code of K984484?
The FDA product code is EBF – Material, Tooth Shade, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3690.