Telio CAD Abutment Solutions
510(k) K151564
Active
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK151564 | Date21 Sep 2015 | StatusActive |
Official records
- FDA 510(k) database K151564
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- NHA
- FDA applicant
- Ivoclar Vivadent, AG
- Device class
- Class II
- Regulation
- 21 CFR Part 872.3630
- Advisory committee
- Dental
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 18 Sep 2026
The Telio CAD Abutment Solutions are dental CAD/CAM abutment components designed for implant-supported hybrid restorations. These components facilitate the fabrication of individual implant-supported hybrid structures, enabling restoration of both anterior and posterior teeth using CAD/CAM technology.
Supplied as a reusable set, these abutments are intended for use in dental laboratories and clinical settings where CAD/CAM milling or 3D printing is employed. The device is classified under product code NHA and holds an FDA 510(k) clearance as substantially equivalent to a predicate device, ensuring compliance with dental regulatory standards. No sterility or single-use designation is specified in the data.
From the manufacturer
Bridging the gap - because even temporary restorations demand excellence With Telio CAD and Telio CAD Abutment Solutions, you can fabricate temporary crowns, bridges and hybrid abutment crowns in a short time, combining efficient workflows with pleasing esthetics, even in temporary restorations.
Telio CAD are cross-linked PMMA blocks for the efficient fabrication of long-term temporaries (flexural strength: 135 MPa [1]). As a result of an optimized manufacturing process, the restorations feature a smooth surface that can be quickly and efficiently polished.