Signum composite flow +6 more— 510(k) K240660
Substantially EquivalentKulzer, LLC
FDA 510(k) clearance K240660 for Signum composite flow +6 more, Substantially Equivalent on 2024-09-17. Applicant: Kulzer, LLC. Device class: 2.
Clearance details
- Device name as filed
- Signum composite flow; Signum universal bond; Signum metal bond ; Signum composite; Signum matrix; Signum liquid; Signum cre-active
- Applicant
- Kulzer, LLC
- Product code
- Code EBF
- Device class
- Class 2
- Regulation
- 21 CFR 872.3690
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- South Bend, IN, US
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