Identifiers
- 510(k) Number
- K981618 FDA 510(k)
- FDA Product Code
- EMA FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 872.3275 FDA 510(k)
- Regulation Number
- 872.3275 FDA 510(k)
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Liquid A is a dental cement. It is classified as a class 2 device.
The device is supplied by Harry J. Bosworth Co. and has been found substantially equivalent by the FDA. The product code is EMA and the regulation number is 872.3275. It is intended for dental use.
Frequently asked questions
What is the Liquid A used for?
The Liquid A is used for dental purposes, as a cement.
Is the Liquid A a single-use or reusable device?
The device data does not specify whether the Liquid A is single-use or reusable, but it is classified as a class 2 device.
What is the regulatory classification of the Liquid A?
The Liquid A is classified as a class 2 device, with a product code of EMA and regulation number 872.3275.
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 | K981618 | Class II | Active |
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Manufacturer
- Manufacturer
- Harry J. Bosworth Co.
Sources (1)
- FDA 510(k) K981618 24 fields · synced Oct 6, 2026