Wil-O-Dont Orthodontic Material/Wil-O-Lux
FDA 510(k) K920557 · Wilde-USA, Inc.
510(k) numberK920557
Submission
- Device name
- Wil-O-Dont Orthodontic Material/Wil-O-Lux
- Applicant
- Wilde-USA, Inc.
Chicago, IL, US - Received
- February 5, 1992
- Decision date
- March 20, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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Questions and answers
When was Wil-O-Dont Orthodontic Material/Wil-O-Lux cleared by the FDA?
Wil-O-Dont Orthodontic Material/Wil-O-Lux (K920557) received a 510(k) decision of Substantially Equivalent on March 20, 1992, 44 days after the submission was received.
What is the product code of K920557?
The FDA product code is EBI – Resin, Denture, Relining, Repairing, Rebasing, a Class II (moderate risk) device regulated under 21 CFR 872.3760.