Enhance Dental Restorative
by Johnson & Johnson Professionals, Inc. 510(k)
Active
510(k) K811443
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK811443 | Date16 Jun 1981 | 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- Withdrawn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, 1 Oct 2026
Enhance Dental Restorative is a dental device classified under product code EBF. It is a substantially equivalent device cleared through the traditional 510(k) pathway.
The device was manufactured by Johnson & Johnson Professionals, Inc. and received FDA 510(k) clearance on June 16, 1981, under K811443. It is intended for dental use as indicated by the advisory committee classification.
Other devices from Johnson & Johnson Professionals, Inc.
See all devices from Johnson & Johnson Professionals, Inc. →
Questions
AI-generated answers, 1 Oct 2026
What is the Enhance Dental Restorative device intended for?
The Enhance Dental Restorative device is intended for dental use, as indicated by its advisory committee classification under product code EBF, which pertains to dental devices.
How was the Enhance Dental Restorative device cleared for market?
The device was cleared through the traditional 510(k) pathway as a substantially equivalent device, receiving FDA 510(k) clearance on June 16, 1981, under K811443.
Who manufactures the Enhance Dental Restorative device and where is it located?
The device is manufactured by Johnson & Johnson Professionals, Inc., located at 325 Paramount Dr., Raynham, MA 02767, United States.