Modified Uni-Stick Plastic Ligature
510(k) K902064
Active
Valid until
Not listed
FDA recalls
None foundTrust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE 510(k) | NumberK902064 | Date6 Aug 1990 | StatusActive |
| European Union | CE/MDR EUDAMED | Number— | Date— | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- 510(k) Number
- FDA Product Code
- EJF
- Device Class
- Class I
- Regulation
- 21 CFR Part 872.5410
- Advisory Committee
- Dental
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Modified Uni-Stick Plastic Ligature is a dental elastomeric ligature designed to secure orthodontic brackets to archwires. It features a molded, tab-less design intended for ease of placement and removal, ensuring patient comfort during orthodontic treatment. Constructed from plastic, it provides strength without excessive bulk while maintaining color stability and avoiding heavy metal hazards. This device falls under the category of dental elastomeric ligatures, serving as a critical component in orthodontic appliances.
This device is supplied in multi-stick configurations, including 6-sticks, 10-rings, and 20-sticks, and is intended for single-use. It is classified under product code EJF and has received FDA 510(k) clearance (K902064) and MDR authorization. The Modified Uni-Stick Plastic Ligature is non-latex and hypoallergenic, as specified in its design, ensuring compatibility with patients who may have sensitivities. Storage and handling should follow standard orthodontic practice guidelines to maintain sterility and functionality.
From the manufacturer
Smooth, molded ligature design with .045 inner diameter and .115 outer diameter Strength without bulkiness, color stability without heavy metal hazards, and clean, tab less removal from the stick or ring for patient comfort Available in 6-sticks, Unisticks, 10-rings, and 20-sticks.
Other devices from American Orthodontics
Questions
AI-generated answers, 1 Oct 2026
What is the Modified Uni-Stick Plastic Ligature used for?
The Modified Uni-Stick Plastic Ligature is designed to secure orthodontic brackets to archwires during treatment. Its molded, tab-less design simplifies placement and removal, reducing patient discomfort while maintaining stability. This makes it a key component in orthodontic appliances, ensuring brackets stay in place throughout the alignment process.
How is the Modified Uni-Stick Plastic Ligature supplied, and is it reusable?
This ligature is supplied in multi-stick configurations, including 6-sticks, 10-rings, and 20-sticks. It is explicitly intended for single-use only, meaning each pack should not be reused across multiple patients or treatments. This ensures sterility and compliance with orthodontic best practices.
Is the Modified Uni-Stick Plastic Ligature safe for patients with allergies?
Yes, the Modified Uni-Stick Plastic Ligature is non-latex and hypoallergenic, making it suitable for patients with latex sensitivities or allergies. Its plastic construction also avoids heavy metal hazards, further reducing potential allergic reactions. Always verify patient history before use.
What storage and handling guidelines should be followed for this ligature?
To maintain sterility and functionality, store the Modified Uni-Stick Plastic Ligature according to standard orthodontic practice guidelines. Keep packs sealed until use, avoid exposure to moisture or extreme temperatures, and discard any unused sticks after opening. Proper handling ensures reliability during placement and removal.
What regulatory approvals does this device hold?
The Modified Uni-Stick Plastic Ligature holds FDA 510(k) clearance (K902064) and MDR authorization, confirming its compliance with dental device regulations. These approvals validate its safety and effectiveness for securing orthodontic brackets as intended.