Ortho-Seal
FDA 510(k) K883465 · Bisco, Inc.
510(k) numberK883465
Submission
- Device name
- Ortho-Seal
- Applicant
- Bisco, Inc.
Downers Grove, IL, US - Received
- August 15, 1988
- Decision date
- October 12, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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Questions and answers
When was Ortho-Seal cleared by the FDA?
Ortho-Seal (K883465) received a 510(k) decision of Substantially Equivalent on October 12, 1988, 58 days after the submission was received.
What is the product code of K883465?
The FDA product code is DYH – Adhesive, Bracket And Tooth Conditioner, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3750.