Reference
by Espe Dental AG 510(k)
Active
510(k) K992966
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK992966 | Date7 Oct 1999 | 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- Withdrawn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, 22 Sep 2026
The Reference device is a Class 2 Dental device with product code EBF. It is manufactured by Espe Dental AG. The device has been cleared through the Traditional 510(k) pathway.
The device is supplied by Espe Dental AG, based in Bavaria D-82228 Seefeld, DE. It has been assigned the k_number K992966 and has received FDA 510(k) clearance. The device is a dental device, and its product code is EBF.
Other devices from Espe Dental AG
Questions
AI-generated answers, 22 Sep 2026
What is the Reference device used for?
The Reference device is used for dental purposes, as indicated by its product code EBF and classification as a dental device.
How is the Reference device supplied?
The Reference device is supplied by Espe Dental AG, based in Bavaria D-82228 Seefeld, DE.
What is the regulatory status of the Reference device?
The Reference device has received FDA 510(k) clearance through the Traditional 510(k) pathway, with the k_number K992966.