Restodent Posterior
510(k) K863157
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK863157 | Date25 Sep 1986 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- EBF
- Device Class
- Class II
- Regulation
- 21 CFR Part 872.3690
- Advisory Committee
- Dental
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 27 Sep 2026
The Restodent Posterior is a dental device, classified as a material, tooth shade, resin. It is a device used in dental applications.
The device is supplied by Lee Pharmaceuticals and has been cleared with FDA 510K number K863157. It is a class 2 device with a traditional clearance type, and its decision description is Substantially Equivalent. The device is used in the dental medical specialty and has a product code of EBF.
Other devices from Lee Pharmaceuticals
Questions
AI-generated answers, 27 Sep 2026
What is the Restodent Posterior used for?
The Restodent Posterior is used in dental applications, specifically as a material, tooth shade, resin.
Is the Restodent Posterior a single-use or reusable device?
The device data does not specify whether the Restodent Posterior is single-use or reusable, but it is classified as a material.
What is the regulatory status of the Restodent Posterior?
The Restodent Posterior has been cleared with FDA 510K number K863157, with a decision description of Substantially Equivalent.