Visalys Tooth Primer— 510(k) K191524
Substantially EquivalentKettenbach GmbH & Co. KG
FDA 510(k) clearance K191524 for Visalys Tooth Primer, Substantially Equivalent on 2019-09-29. Applicant: Kettenbach GmbH & Co. KG. Device class: 2.
Clearance details
- Applicant
- Kettenbach GmbH & Co. KG
- Product code
- Code KLE
- Device class
- Class 2
- Regulation
- 21 CFR 872.3200
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Eschenburg, DE
Recent devices under product code KLE
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- K191527 — Visalys CemCore, Visalys Cem Core Try In Paste
- K191523 — Visalys Restorative Primer
Data sourced from openFDA. This site is unofficial and independent of the FDA.