Ceramic Brackets
510(k) K110335
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK110335 | Date19 May 2011 | 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- Withdrawn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
- NJM
- Device class
- Class II
- Regulation
- 21 CFR Part 872.5470
- Advisory committee
- Dental
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 18 Sep 2026
Ceramic Brackets are orthodontic devices designed for bonding to teeth to facilitate tooth alignment. These brackets are made from ceramic material, providing a tooth-colored aesthetic alternative to metal brackets for orthodontic treatment.
These brackets are supplied as single-use, non-sterile devices intended for dental office use. They are classified as Class II medical devices under FDA regulations (872.5470) and have received FDA 510(k) clearance (K110335) as substantially equivalent to predicate devices. Multiple model references are available, as listed in the registration data.
Other devices from Ortho Organizers, Inc.
Questions
AI-generated answers, 18 Sep 2026
Are these ceramic brackets designed for use in both adult and pediatric orthodontic patients, or are they limited to a specific age group?
The ceramic brackets are orthodontic devices intended for bonding to teeth to facilitate tooth alignment, with no age restrictions specified in the data. Since they are classified as Class II devices and cleared via FDA 510(k) (K110335), they are approved for general orthodontic use, which includes both adult and pediatric patients. Always follow clinical guidelines and practitioner judgment for patient-specific suitability.
How are these ceramic brackets supplied, and do they require any special handling before use?
The ceramic brackets are supplied as single-use, non-sterile devices, intended exclusively for dental office use. Since they are not sterile, they should not be used in procedures requiring sterile conditions (e.g., surgical orthodontics). They are packaged for direct application by dental professionals, so no additional preparation is needed beyond standard orthodontic bonding protocols.
What sizes or model variations are available for these ceramic brackets, and how do I determine which one to order?
Multiple model references are available for these ceramic brackets, as indicated by the registration data (e.g., FEI numbers like 3009048384, 3015259864, etc.). These variations likely correspond to different tooth sizes, shapes, or bracket designs (e.g., standard, lingual, or specialized attachments). Consult the manufacturer’s catalog or technical documentation to match the correct model to your patient’s dental anatomy or treatment plan.
Do these ceramic brackets require any specific storage conditions, and how long can they be stored before use?
The data does not specify exact storage conditions or shelf life, but as single-use, non-sterile devices, they should be stored in a clean, dry environment protected from moisture, extreme temperatures, or physical damage. Follow the manufacturer’s instructions (available from Ortho Organizers, Inc.) for optimal storage to maintain integrity until use. Always check expiration dates if applicable.
What regulatory pathway was followed for FDA clearance of these ceramic brackets, and how does that affect their use in clinical practice?
These ceramic brackets received FDA 510(k) clearance (K110335) under the Traditional 510(k) Review pathway, with a decision of *Substantially Equivalent* to predicate devices. This means they were determined to have the same intended use, technological characteristics, and performance as legally marketed alternatives. Clinically, this clearance confirms their safety and effectiveness for orthodontic tooth alignment when used as directed by dental professionals.