Flowable Hybrid
FDA 510(k) K980298 · Cosmedent, Inc.
510(k) numberK980298
Submission
- Device name
- Flowable Hybrid
- Applicant
- Cosmedent, Inc.
Chicago, IL, US - Received
- January 27, 1998
- Decision date
- March 9, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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Questions and answers
When was Flowable Hybrid cleared by the FDA?
Flowable Hybrid (K980298) received a 510(k) decision of Substantially Equivalent on March 9, 1998, 41 days after the submission was received.
What is the product code of K980298?
The FDA product code is EBD – Coating, Filling Material, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3310.