Tetric CAD
510(k) K173573
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK173573 | Date7 Jun 2018 | 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- Withdrawn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
- EBF
- FDA applicant
- Ivoclar Vivadent, AG
- Device class
- Class II
- Regulation
- 21 CFR Part 872.3690
- Advisory committee
- Dental
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 18 Sep 2026
Tetric CAD is a dental composite block classified under composite resin restorative materials, designed for chairside fabrication of single-tooth restorations. It is formulated to provide aesthetic results with high polishability, enabling durable restorations in a single treatment session.
This device is supplied as a reusable dental material and is intended for use in clinical dental settings. It requires no special sterility measures beyond standard dental practice protocols and is compatible with common dental instruments. Authorised under FDA 510(k) clearance (K173573) as substantially equivalent to a predicate device, Tetric CAD is distributed by Ivoclar Vivadent AG, Schaan, Liechtenstein.
From the manufacturer
Tetric CAD is an esthetic composite block designed for the efficient fabrication of single-tooth restorations in just one treatment session. Its excellent polishability allows dentists to deliver long-lasting restorations to their patients in just a few steps.
Tetric CAD is an aesthetic composite block designed for the efficient fabrication of single-tooth restorations in just one treatment session. Its excellent polishability allows dentists to deliver long-lasting restorations to their patients in just a few steps.
Other devices from Ivoclar Vivadent AG
Questions
AI-generated answers, 18 Sep 2026
What clinical setting is Tetric CAD intended for and how is it used in a single treatment session?
Tetric CAD is designed exclusively for clinical dental settings where chairside fabrication of single-tooth restorations is required. It is a dental composite block used to create aesthetic restorations with high polishability, allowing dentists to complete durable restorations in one visit. The material is formulated to simplify workflow by enabling direct fabrication of restorations without additional steps, making it ideal for same-day crowns or inlays/onlays.
Is Tetric CAD reusable or single-use, and what standard protocols apply to its handling?
Tetric CAD is supplied as a reusable dental material, meaning it can be used multiple times in clinical settings. Since it is not a sterile device, it does not require special sterility measures beyond those already standard in dental practices—such as proper cleaning, disinfection, and sterilization protocols for reusable dental materials. Always follow manufacturer guidelines for handling to ensure safety and longevity.
How does Tetric CAD differ from traditional composite fillings in terms of application and durability?
Unlike traditional composite fillings, which are applied incrementally in layers, Tetric CAD is a pre-formed block designed for chairside milling or carving to create precise single-tooth restorations. This formulation ensures high polishability and durability, allowing for long-lasting restorations in a single session. Its block form streamlines fabrication compared to hand-layered composites, reducing chair time while maintaining aesthetic and functional outcomes.
What regulatory pathway was followed for Tetric CAD’s FDA clearance, and what does that mean for its use?
Tetric CAD received FDA clearance through an Abbreviated 510(k) process, determined to be substantially equivalent to a predicate device under product code EBF (Dental Restorative Materials). This means the FDA reviewed it against existing dental composite blocks and confirmed it meets safety and effectiveness standards for chairside restorations. Clinicians can rely on this clearance as evidence of compliance with U.S. regulatory requirements for its intended use.