Monobond Etch & Prime
510(k) K150164
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK150164 | Date3 Apr 2015 | 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- Withdrawn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
- 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, 18 Sep 2026
The Monobond Etch & Prime is a Agent, Tooth Bonding, Resin (per FDA nomenclature) designed to condition silica-based ceramic surfaces. It combines etching and silanization in a single step to prepare these surfaces for adhesive bonding with luting composites, such as those from the Variolink or Multilink product lines. This process enhances the mechanical retention and durability of restorative materials on ceramic substrates.
This single-component, self-etching primer is supplied as an alcoholic aqueous solution and is intended for use with pre-treated and non-pre-treated glass-ceramic materials. It is classified as a Class II device under FDA regulations (21 CFR 872.3200) and has received FDA 510K clearance (K150164). The product is non-sterile and intended for single-use in dental settings. No MRI safety information is specified, and storage conditions are not detailed in the provided data.
Other devices from Ivoclar Vivadent AG
Questions
AI-generated answers, 18 Sep 2026
What types of ceramic surfaces is the Monobond Etch & Prime designed to prepare for bonding with luting composites, and how does it improve the bond strength?
The Monobond Etch & Prime is specifically formulated to condition silica-based ceramic surfaces, such as glass-ceramic materials. It combines etching and silanization in a single step, creating a durable chemical bond between the ceramic and adhesive luting composites like those from the Variolink or Multilink product lines. This dual-action process enhances mechanical retention and long-term durability of restorative materials on ceramic substrates.
Is the Monobond Etch & Prime reusable, or is it intended for single-use in a dental setting?
The Monobond Etch & Prime is explicitly labeled as non-sterile and intended for single-use in dental procedures. This designation aligns with standard practice for bonding agents to ensure patient safety and prevent cross-contamination between patients.
How is the Monobond Etch & Prime supplied, and what should clinicians know about its storage?
The Monobond Etch & Prime is supplied as an alcoholic aqueous solution in a single-component format. While the provided data does not specify exact storage conditions, typical guidelines for similar dental bonding agents recommend storing it in a cool, dry place away from direct sunlight and extreme temperatures. Since it is non-sterile, it should not be sterilized before use.
What regulatory pathway was followed for FDA clearance of the Monobond Etch & Prime, and what does this mean for its use in clinical practice?
The Monobond Etch & Prime received FDA 510K clearance (K150164) under the Traditional 510(k) pathway, with a decision of Substantially Equivalent (SESE) to a predicate device. This means the FDA determined it has the same intended use and technological characteristics as a previously cleared product, ensuring it meets safety and effectiveness standards for use as a Tooth Bonding, Resin Agent in dental settings. Clinicians can rely on this clearance for its intended application in preparing silica-based ceramics for bonding.