Basic Calcium Hydroxide Liner
by Ivoclar North America, Inc. 510(k)
Active
510(k) K896529
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK896529 | Date16 Jan 1990 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- EJK
- Device Class
- Class II
- Regulation
- 21 CFR Part 872.3250
- Advisory Committee
- Dental
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 6 Oct 2026
The Basic Calcium Hydroxide Liner is a device material intended to be applied to the interior of a prepared cavity before insertion of restorative material to protect the pulp of a tooth. It is classified as a Liner, Cavity, Calcium Hydroxide. The device is used in dental applications.
The Basic Calcium Hydroxide Liner is supplied by Ivoclar North America, Inc. and has been cleared by the FDA with a 510K number of K896529. The device has a product code of EJK and is regulated under 21 CFR 872.3250. It is a Class II device with special controls.
Other devices from Ivoclar North America, Inc.
Questions
AI-generated answers, 6 Oct 2026
What is the purpose of the Basic Calcium Hydroxide Liner?
The Basic Calcium Hydroxide Liner is used to protect the pulp of a tooth by applying it to the interior of a prepared cavity before insertion of restorative material.
Is the Basic Calcium Hydroxide Liner supplied sterile?
The description does not specify if the device is supplied sterile, but it is intended for use in dental applications where sterility is often crucial.
What is the regulatory classification of the Basic Calcium Hydroxide Liner?
The device is classified as a Class II device with special controls, regulated under 21 CFR 872.3250, and has been cleared by the FDA with a 510K number.