Multilink Automix
510(k) K123397
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK123397 | Date31 Jan 2013 | 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- Withdrawn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
Multilink Automix is a luting composite resin designed for the permanent adhesive cementation of indirect restorations, including silicate and oxide ceramics, metal-ceramic (PFM) restorations, and composite resins. It provides a strong, durable bond to tooth structure when used in conjunction with Multilink Primers A and B, ensuring long-term retention of dental prosthetics.
This dual-cure (self-curing with optional light-curing) material is supplied as a ready-to-use system, intended for clinical use in dental offices. It is classified under product code EBF and has received FDA 510(k) clearance as a dental device. The device is non-sterile and intended for single-use per manufacturer specifications.
From the manufacturer
Multilink Automix is a luting material for the permanent adhesive cementation of indirect restorations made of silicate and oxide ceramics, metal and metal-ceramics (PFM) and composite resins. Used together with the matching Multilink Primers A and B, the material generates a strong and long-lasting bond to the tooth structure.
Multilink® Automix is a luting composite for the permanent adhesive cementation of indirect restorations made of silicate and oxide ceramics, metal and metal-ceramics (PFM) and composite resins. Used together with the matching Multilink Primers A and B, the material generates a strong and long-lasting bond to the tooth structure.
Other devices from Ivoclar Vivadent AG
Questions
AI-generated answers, 18 Sep 2026
What types of dental restorations is Multilink Automix specifically designed to permanently bond with?
Multilink Automix is formulated for the permanent adhesive cementation of indirect restorations such as silicate and oxide ceramics, metal-ceramic (PFM) restorations, and composite resins. It requires the use of Multilink Primers A and B to achieve a strong, durable bond to tooth structure, ensuring long-term retention of these prosthetics.
Is Multilink Automix intended for reuse in a clinical setting, or is it meant to be used only once?
Multilink Automix is explicitly specified by the manufacturer as a single-use product. This designation ensures optimal performance and sterility for each clinical application, preventing potential contamination or degradation from repeated use.
How is Multilink Automix supplied, and does it require any additional preparation before use?
Multilink Automix is supplied as a ready-to-use system, meaning no further mixing or preparation is required in the clinical setting. It combines dual-cure technology (self-curing with optional light-curing) for versatility in application, making it convenient for immediate use in dental offices.
What storage conditions should be considered for Multilink Automix to maintain its integrity?
While specific storage instructions aren’t detailed in the provided data, the non-sterile nature of Multilink Automix implies it should be stored in a clean, dry environment away from direct sunlight or extreme temperatures to preserve its properties until use. Always follow the manufacturer’s packaging guidelines for optimal shelf life.