Band, Material, Orthodontic
The Orthodontic Band Material is a dental device consisting of thin metal strip material that is shaped and fitted around individual teeth to provide an anchor for orthodontic attachments such as brackets, tubes, and springs during orthodontic treatment. It is classified as FDA Class 1, the lowest risk category, subject only to general controls and no premarket submission is required. The product code is DYO and the applicable regulation is 21 CFR 872.5410, under the Dental medical specialty.
Research product code DYO in seconds
The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.
Free to try · every answer cites its records
Basic Information
- Product Code
- DYO
- Device Class
- FDA class 1
- Regulation Number
- 872.5410
- Medical Specialty
- Dental
- Review Panel
- DE
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 3 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K935152 | DENTAURUM DENTAFORM BANDS, DENTAURUM STANDARD | Jan 31, 1994 | Substantially Equivalent | Dentauraum, Inc. |
| K931980 | STAINLESS STEEL ORTHODONTIC PRODUCTS | Sep 01, 1993 | Substantially Equivalent | Ortho Organizers, Inc. |
| K844034 | SONOCARE | Jan 23, 1985 | Substantially Equivalent | Echo Ultrasound |
FEI Numbers
This FDA classification entry is associated with 45 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 45 registration numbers. Click on an entry to view related FDA registrations.