Visalys CemCore, Visalys Cem Core Try In Paste— 510(k) K191527
Substantially EquivalentKettenbach GmbH & Co. KG
FDA 510(k) clearance K191527 for Visalys CemCore, Visalys Cem Core Try In Paste, Substantially Equivalent on 2019-11-08. Applicant: Kettenbach GmbH & Co. KG. Device class: 2.
Clearance details
- Applicant
- Kettenbach GmbH & Co. KG
- Product code
- Code EMA
- Device class
- Class 2
- Regulation
- 21 CFR 872.3275
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Eschenburg, DE
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