Edgewise Ceramic Brackets, Roth Ceramic Brackets
by Dental Morelli 510(k)
Active
510(k) K131197
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK131197 | Date27 Aug 2013 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- NJM
- Device Class
- Class II
- Regulation
- 21 CFR Part 872.5470
- Advisory Committee
- Dental
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Edgewise Ceramic Brackets and Roth Ceramic Brackets are orthodontic ceramic brackets designed for dental alignment. These devices are classified as ceramic orthodontic brackets and are intended for bonding to teeth to facilitate controlled tooth movement via orthodontic wires. Their translucent alumina composition reduces visibility while maintaining mechanical stability for treatment.
These brackets are supplied as single-use, non-sterile devices intended for use in orthodontic offices. They are regulated under FDA 510(k) clearance (K131197) as Class II devices under product code NJM (Bracket, Ceramic, Orthodontic). Multiple reference codes (e.g., 3009048384, 1018901) correspond to specific kit configurations, including single-patient variants. Storage follows standard orthodontic practice, and no MRI safety restrictions apply.
Other devices from Dental Morelli
Questions
AI-generated answers, 1 Oct 2026
What are the Edgewise Ceramic Brackets designed for?
The Edgewise Ceramic Brackets are orthodontic devices designed specifically for bonding to teeth to facilitate controlled tooth movement during orthodontic treatment. Their translucent alumina composition reduces visibility while maintaining mechanical stability, making them ideal for aesthetic considerations in dental alignment.
How are these brackets supplied, and are they sterile?
The Edgewise Ceramic Brackets are supplied as single-use, non-sterile devices. They are intended for use in orthodontic offices and follow standard orthodontic handling practices, which typically involve sterilizing tools and surfaces rather than the brackets themselves.
Are these brackets reusable, or are they meant for single-patient use?
These brackets are explicitly designed for single-use only. They are not intended for reuse on multiple patients, adhering to standard orthodontic practice guidelines to ensure patient safety and hygiene.
What reference codes or kit configurations are available for these brackets?
Multiple reference codes correspond to specific kit configurations, including single-patient variants. Examples include codes like 3009048384, 1018901, and others listed under the product’s regulatory details. These configurations allow for flexibility in ordering based on clinical needs.
Do these brackets have any special storage requirements or MRI safety restrictions?
The brackets follow standard orthodontic storage practices, which generally involve keeping them in a clean, dry environment away from direct sunlight or extreme temperatures. There are no MRI safety restrictions associated with these ceramic brackets, as they are not magnetic.