Visalys Tooth Primer
FDA 510(k) K191524 · Kettenbach GmbH & Co. KG
510(k) numberK191524
Submission
- Device name
- Visalys Tooth Primer
- Applicant
- Kettenbach GmbH & Co. KG
Eschenburg, DE - Received
- June 10, 2019
- Decision date
- September 29, 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 Visalys Tooth Primer cleared by the FDA?
Visalys Tooth Primer (K191524) received a 510(k) decision of Substantially Equivalent on September 29, 2019, 111 days after the submission was received.
What is the product code of K191524?
The FDA product code is KLE – Agent, Tooth Bonding, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3200.