← Back to catalogue
Signum composite flow +6 more models
FDA 510(k)Class II (US FDA 510(k))
510(k) K240660
by Kulzer, LLC
Identifiers
- 510(k) Number
- K240660 FDA 510(k)
- FDA Product Code
- EBF FDA 510(k)
- Models / Variants
- Signum composite flow FDA 510(k)Signum universal bond FDA 510(k)Signum metal bond FDA 510(k)Signum composite FDA 510(k)Signum matrix FDA 510(k)Signum liquid FDA 510(k)Signum cre-active FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 872.3690 FDA 510(k)
- Regulation Number
- 872.3690 FDA 510(k)
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Signum composite flow +6 more models by Kulzer, LLC — Class II — FDA_510K — listed in FDA 510(k) — 7 models — regulatory data on deviCERTS
Authorization Coverage (1 country)
Regulatory Authorizations
United States Active
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K240660 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Kulzer, LLC
Sources (1)
- FDA 510(k) K240660 24 fields · synced Jun 18, 2026