Identifiers
- 510(k) Number
- K892452 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 Palaseal is a dental device. It is substantially equivalent and has a product code of EBI.
The Palaseal is supplied by Kulzer, Inc. and has been given the authorization FDA 510K. The device has a k number of K892452 and is reviewed by the advisory committee DE.
Frequently asked questions
What is the Palaseal device used for?
The Palaseal is used in dental applications, as indicated by its product code EBI and review by the Dental advisory committee.
How is the Palaseal device supplied?
The Palaseal is supplied by Kulzer, Inc., the manufacturer, with a specific k number of K892452 for tracking and regulatory purposes.
What is the regulatory status of the Palaseal device?
The Palaseal has been given FDA 510K authorization, indicating it is substantially equivalent to a pre-existing device, with a decision date of 1989-06-16.
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 | K892452 | Class II | Active |
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Manufacturer
- Manufacturer
- Kulzer, Inc.
Sources (1)
- FDA 510(k) K892452 24 fields · synced Sep 24, 2026