Retractofoam
FDA 510(k) K050013 · Coltene/Whaledent AG
510(k) numberK050013
Submission
- Device name
- Retractofoam
- Applicant
- Coltene/Whaledent AG
New York, NY, US - Received
- January 3, 2005
- Decision date
- February 9, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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Questions and answers
When was Retractofoam cleared by the FDA?
Retractofoam (K050013) received a 510(k) decision of Substantially Equivalent on February 9, 2005, 37 days after the submission was received.
What is the product code of K050013?
The FDA product code is ELW – Material, Impression, a Class II (moderate risk) device regulated under 21 CFR 872.3660.