Pulpdent Orthodontic Bracket Adhesive
FDA 510(k) K911286 · Pulpdent Corp.
510(k) numberK911286
Submission
- Device name
- Pulpdent Orthodontic Bracket Adhesive
- Applicant
- Pulpdent Corp.
Watertown, MA, US - Received
- March 19, 1991
- Decision date
- July 5, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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Questions and answers
When was Pulpdent Orthodontic Bracket Adhesive cleared by the FDA?
Pulpdent Orthodontic Bracket Adhesive (K911286) received a 510(k) decision of Substantially Equivalent on July 5, 1991, 108 days after the submission was received.
What is the product code of K911286?
The FDA product code is DYH – Adhesive, Bracket And Tooth Conditioner, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3750.