Zipbond
FDA 510(k) K191656 · Sdi Limited
510(k) numberK191656
Submission
- Device name
- Zipbond
- Applicant
- Sdi Limited
Bayswater, AU - Received
- June 21, 2019
- Decision date
- December 2, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Zipbond cleared by the FDA?
Zipbond (K191656) received a 510(k) decision of Substantially Equivalent on December 2, 2019, 164 days after the submission was received.
What is the product code of K191656?
The FDA product code is KLE – Agent, Tooth Bonding, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3200.