Pulpdent Sealant/Paste Orthodontic Bracket Adhesive System
FDA 510(k) K020115 · Pulpdent Corp.
510(k) numberK020115
Submission
- Device name
- Pulpdent Sealant/Paste Orthodontic Bracket Adhesive System
- Applicant
- Pulpdent Corp.
Watertown, MA, US - Received
- January 11, 2002
- Decision date
- February 28, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Pulpdent Sealant/Paste Orthodontic Bracket Adhesive System cleared by the FDA?
Pulpdent Sealant/Paste Orthodontic Bracket Adhesive System (K020115) received a 510(k) decision of Substantially Equivalent on February 28, 2002, 48 days after the submission was received.
What is the product code of K020115?
The FDA product code is DYH – Adhesive, Bracket And Tooth Conditioner, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3750.