LiquiBand Dental
510(k) K993556
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK993556 | Date3 Jan 2000 | 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- Withdrawn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
- EMA
- Device Class
- Class II
- Regulation
- 21 CFR Part 872.3275
- Advisory Committee
- Dental
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
LiquiBand Dental is a dental adhesive classified as a Cement, Dental (FDA product code EMA). It is an n-butyl cyanoacrylate-based liquid designed for bonding dental caps and crowns to teeth, providing a secure and durable attachment.
This single-use, non-sterile adhesive is supplied as a clear, free-flowing liquid monomer with stabilizers. It is intended for use in dental offices and requires proper handling per manufacturer instructions. The device holds an FDA 510(k) clearance (K993556) under regulation 872.3275 and is regulated as a Class II medical device.
Other devices from Medlogic Global Corp.
Questions
AI-generated answers, 1 Oct 2026
What is LiquiBand Dental used for?
LiquiBand Dental is a dental adhesive designed specifically for bonding dental caps and crowns to teeth. It provides a secure and durable attachment, ensuring stability during the healing process. The adhesive is formulated as a liquid monomer with stabilizers, making it suitable for precise application in dental offices.
Is LiquiBand Dental sterile or non-sterile?
LiquiBand Dental is classified as a non-sterile adhesive. While it is intended for clinical use in dental offices, it does not come pre-sterilized. Proper handling and adherence to manufacturer instructions are essential to maintain its integrity and effectiveness before use.
How is LiquiBand Dental supplied, and is it single-use?
LiquiBand Dental is supplied as a clear, free-flowing liquid monomer in single-use packaging. This design ensures each application is fresh and uncontaminated, reducing the risk of cross-infection or degradation in performance. The single-use nature also aligns with dental office protocols for hygiene and safety.
What regulatory clearance does LiquiBand Dental hold?
LiquiBand Dental holds an FDA 510(k) clearance (K993556) under regulation 872.3275, classifying it as a Class II medical device. This clearance confirms that the device meets FDA standards for safety and effectiveness as a dental cement, ensuring it can be legally marketed and used in the United States for its intended purpose.
Are there different sizes or models of LiquiBand Dental?
The provided data does not specify distinct sizes or models beyond the general product name and classification. However, the adhesive is supplied as a liquid monomer, which may be packaged in various volumes or formats depending on the manufacturer’s standard offerings. For precise details on packaging or variants, refer to the manufacturer’s product documentation or contact Medlogic Global Corp.