Hyperelastic Wire
FDA 510(k) K112640 · Ormco Corp.
510(k) numberK112640
Submission
- Device name
- Hyperelastic Wire
- Applicant
- Ormco Corp.
Orange, CA, US - Received
- September 12, 2011
- Decision date
- November 16, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Hyperelastic Wire cleared by the FDA?
Hyperelastic Wire (K112640) received a 510(k) decision of Substantially Equivalent on November 16, 2011, 65 days after the submission was received.
What is the product code of K112640?
The FDA product code is DZC – Wire, Orthodontic, a Class I (low risk) device regulated under 21 CFR 872.5410.