Spirit MB Orthodontic Bracket
510(k) K955333
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK955333 | Date4 Jan 1996 | 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- Withdrawn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
- Full name
- Spirit Mb
- 510(k) Number
- FDA Product Code
- DYW
- FDA applicant
- Ormco Corp.
- Device Class
- Class II
- Regulation
- 21 CFR Part 872.5470
- Advisory Committee
- Dental
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 20 Sep 2026
The Spirit MB Orthodontic Bracket is a plastic orthodontic bracket designed for fixed attachment to teeth. It serves as an anchor point for archwires during orthodontic treatment, facilitating tooth alignment and movement. Manufactured from a proprietary polymer blend, it offers aesthetic advantages while maintaining mechanical retention through a patterned base. This device falls under the FDA’s classification of plastic orthodontic brackets (product code DYW) and is intended for use in dental orthodontics.
Spirit MB brackets are supplied as single-use, non-sterile devices intended for direct bonding to enamel. They are classified as Class II medical devices under FDA regulations (872.5470) and are distributed in packs of five, sized for maxillary teeth. No MRI safety considerations are specified, and proper storage involves protection from moisture and physical damage. The device holds an FDA 510(k) clearance (K955333) for substantial equivalence, ensuring compliance with dental orthodontic standards.
Other devices from Ormco Corporation
Questions
AI-generated answers, 20 Sep 2026
Are Spirit MB brackets reusable, or are they intended for single-use only?
Spirit MB brackets are designed for single-use only and are not meant to be reused. They are supplied as non-sterile devices intended for direct bonding to enamel during orthodontic treatment, ensuring patient safety and hygiene standards.
What storage conditions should I follow to maintain the integrity of Spirit MB brackets?
To preserve the Spirit MB brackets, store them in a dry environment protected from moisture and physical damage. Avoid exposure to extreme temperatures or direct sunlight, as these factors could compromise the polymer material or adhesive properties.
Are Spirit MB brackets compatible with MRI procedures, or are there any safety concerns?
The Spirit MB brackets do not specify MRI safety considerations in their documentation. While the plastic material itself is generally non-ferromagnetic, it’s always best to confirm with your MRI facility before use, as individual protocols may vary.
What sizes and models of Spirit MB brackets are available, and are they limited to specific teeth?
Spirit MB brackets are supplied in packs of five, specifically sized for maxillary teeth. The manufacturer does not list additional models or sizes beyond this standard configuration, so they are intended for general use in the upper arch.
How does the FDA classify the Spirit MB bracket, and what does its clearance status mean for clinicians?
The Spirit MB bracket is classified as a Class II medical device under FDA regulations (product code DYW) and holds an FDA 510(k) clearance (K955333). This clearance confirms it is substantially equivalent to a legally marketed predicate device, ensuring it meets dental orthodontic standards for safety and effectiveness.