Aligner, Bracket, Orthodontic
The Orthodontic Bracket Aligner is a dental hand instrument used to precisely position and seat orthodontic brackets on tooth surfaces during bonding procedures, ensuring accurate bracket placement for effective tooth movement. 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 ECQ and the applicable regulation is 21 CFR 872.4565, under the Dental medical specialty.
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Basic Information
- Product Code
- ECQ
- Device Class
- FDA class 1
- Regulation Number
- 872.4565
- 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 2 510(k) clearances via K numbers.
FEI Numbers
This FDA classification entry is associated with 81 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 81 registration numbers. Click on an entry to view related FDA registrations.