Bisco Universal Hybrid Composite
FDA 510(k) K934247 · Bisco, Inc.
510(k) numberK934247
Submission
- Device name
- Bisco Universal Hybrid Composite
- Applicant
- Bisco, Inc.
Itasca, IL, US - Received
- August 30, 1993
- Decision date
- November 29, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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Questions and answers
When was Bisco Universal Hybrid Composite cleared by the FDA?
Bisco Universal Hybrid Composite (K934247) received a 510(k) decision of Substantially Equivalent on November 29, 1993, 91 days after the submission was received.
What is the product code of K934247?
The FDA product code is EBF – Material, Tooth Shade, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3690.