Excel Bracket Adhesive
FDA 510(k) K854050 · Johnson & Johnson Professionals, Inc.
510(k) numberK854050
Submission
- Device name
- Excel Bracket Adhesive
- Applicant
- Johnson & Johnson Professionals, Inc.
East Windsor, NJ, US - Received
- October 3, 1985
- Decision date
- November 26, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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Questions and answers
When was Excel Bracket Adhesive cleared by the FDA?
Excel Bracket Adhesive (K854050) received a 510(k) decision of Substantially Equivalent on November 26, 1985, 54 days after the submission was received.
What is the product code of K854050?
The FDA product code is DYH – Adhesive, Bracket And Tooth Conditioner, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3750.