Identifiers
- 510(k) Number
- K901789 FDA 510(k)
- FDA Product Code
- EBI FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 872.3760 FDA 510(k)
- Regulation Number
- 872.3760 FDA 510(k)
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Paladon 65 is a dental device. It is substantially equivalent and has a product code of EBI.
The Paladon 65 is supplied by Kulzer, Inc. and has been given FDA 510K authorization. It is used in dental settings.
Frequently asked questions
What is the Paladon 65 used for?
The Paladon 65 is used in dental settings, indicating its application in various dental procedures and treatments.
Is the Paladon 65 authorized by the FDA?
Yes, the Paladon 65 has been given FDA 510K authorization, indicating it has been cleared for use in the US.
What type of equivalence does the Paladon 65 have?
The Paladon 65 is substantially equivalent, meaning it has been compared to and found similar to existing devices on the market.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K901789 | Class II | Active |
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Manufacturer
- Manufacturer
- Kulzer, Inc.
Sources (1)
- FDA 510(k) K901789 24 fields · synced Sep 26, 2026