Certain Dental Restorative
by Johnson & Johnson Professionals, Inc. 510(k)
Active
510(k) K831559
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK831559 | Date30 Jun 1983 | 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- Withdrawn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
- EBF
- Device Class
- Class II
- Regulation
- 21 CFR Part 872.3690
- Advisory Committee
- Dental
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 23 Sep 2026
This device is a dental restorative material used for repairing or restoring tooth structure. It is intended for use in dental procedures to restore function and morphology of teeth.
The device is supplied non-sterile and is intended for single use. It is used in dental clinical settings and has received FDA 510(k) clearance under product code EBF, with the manufacturer being Johnson & Johnson Professionals, Inc.
Other devices from Johnson & Johnson Professionals, Inc.
See all devices from Johnson & Johnson Professionals, Inc. →
Questions
AI-generated answers, 23 Sep 2026
What is CERTAIN *DENTAL RESTORATIVE used for?
CERTAIN *DENTAL RESTORATIVE is a dental restorative material used to repair or restore tooth structure, intended to restore function and morphology of teeth during dental procedures.
Is CERTAIN *DENTAL RESTORATIVE sterile or non-sterile, and is it for single use or reuse?
CERTAIN *DENTAL RESTORATIVE is supplied non-sterile and is intended for single use only, meaning it should not be reprocessed or reused after initial application in a dental procedure.
How is CERTAIN *DENTAL RESTORATIVE supplied and where is it used?
CERTAIN *DENTAL RESTORATIVE is supplied non-sterile for single use and is intended for use in dental clinical settings by professionals to restore tooth structure during restorative treatments.