The Bracket Assembly W/ Security System II
FDA 510(k) K921245 · Ormco Corp.
510(k) numberK921245
Submission
- Device name
- The Bracket Assembly W/ Security System II
- Applicant
- Ormco Corp.
Glendora, CA, US - Received
- March 16, 1992
- Decision date
- May 5, 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 The Bracket Assembly W/ Security System II cleared by the FDA?
The Bracket Assembly W/ Security System II (K921245) received a 510(k) decision of Substantially Equivalent on May 5, 1992, 50 days after the submission was received.
What is the product code of K921245?
The FDA product code is DYH – Adhesive, Bracket And Tooth Conditioner, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3750.