Adhese Universal DC, Cention Primer
510(k) K210804
Active
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK210804 | Date7 Jun 2022 | StatusActive |
Official records
- FDA 510(k) database K210804
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- KLE
- FDA applicant
- Ivoclar Vivadent, AG
- Device class
- Class II
- Regulation
- 21 CFR Part 872.3200
- Advisory committee
- Dental
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 20 Sep 2026
The Adhese Universal DC, Cention Primer is a resin-based tooth bonding agent designed for universal adhesive applications in dentistry. Classified as an agent for tooth bonding under FDA category KLE, it functions as a primer to enhance adhesion between dental restorative materials and tooth structure, supporting both direct and indirect restorative procedures. Its dual-cure capability allows for self-curing or light-curing depending on clinical requirements, ensuring versatility in bonding scenarios. The primer is specifically formulated to improve bonding strength for materials such as Cention, a resin-infiltrated ceramic composite.
This device is supplied as a single-component system, intended for use in clinical settings where precise adhesion is critical. It is not sterile at the point of sale but is intended for single-use per application, adhering to standard dental practice protocols. The primer is compatible with all etching techniques and is regulated under FDA 510(k) clearance (K210804), classified as a Class II medical device. Storage conditions require protection from moisture and extreme temperatures, as specified in manufacturer guidelines. No MRI safety information is provided, and its use is restricted to dental professionals in controlled clinical environments.
From the manufacturer
Discover Adhese Universal DC, Ivoclar's single-component, dual-cured adhesive for direct and indirect restorations. Suitable for all etching techniques.
Adhese Universal DC -. Adhese Universal DC by Ivoclar is a single-component, dual-cured adhesive for universal use. It is particularly suitable for bonding indirect restorations in situations where self-curing is required or desired.