TelioCAD Multi
510(k) K153753
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK153753 | Date12 Apr 2016 | 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- Withdrawn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
- EBG
- Device class
- Class II
- Regulation
- 21 CFR Part 872.3770
- Advisory committee
- Dental
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 25 Sep 2026
TelioCAD Multi is a dental CAD/CAM block used for the manufacture of long-term temporaries with a maximum wear period of 12 months. The restorations can be milled in the dental practice, in a dental laboratory, or outsourced to a milling center.
The device is supplied as resin blocks for crown and bridge applications and is classified under product code EBG with Class II special controls. It is authorized under FDA 510(k) clearance K153753, issued on April 12, 2016.
Other devices from Ivoclar Vivadent, Inc.
Questions
AI-generated answers, 25 Sep 2026
What is TelioCAD Multi used for?
TelioCAD Multi is a dental CAD/CAM block specifically designed for the manufacture of long-term temporaries with a maximum wear period of 12 months, suitable for crown and bridge applications.
How is TelioCAD Multi supplied?
The device is supplied as resin blocks that can be milled in the dental practice, in a dental laboratory, or outsourced to a milling center for creating restorations.
What is the regulatory status of TelioCAD Multi?
TelioCAD Multi is authorized under FDA 510(k) clearance K153753, issued on April 12, 2016, and is classified under product code EBG with Class II special controls.
Can TelioCAD Multi be reused after milling?
The device information does not specify whether TelioCAD Multi blocks can be reused after milling, as it is designed for manufacturing single restorations from each block.