Setter, Band, Orthodontic
The Orthodontic Band Setter is a dental hand instrument used to seat orthodontic bands onto teeth and position them at the correct gingival height prior to cementation. 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 ECR and the applicable regulation is 21 CFR 872.4565, under the Dental medical specialty.
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Basic Information
- Product Code
- ECR
- 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 3 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K951776 | BAND SEATER | May 23, 1995 | Substantially Equivalent | Ormco Corp. |
| K935156 | DENTAURUM BAND SEATER AND BAND SEATING INSTRUMENTS | Feb 03, 1994 | Substantially Equivalent | Dentauraum, Inc. |
| K843018 | FLEXI-POST | Sep 27, 1984 | Substantially Equivalent | Essential Dental Systems, Inc. |
FEI Numbers
This FDA classification entry is associated with 63 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 63 registration numbers. Click on an entry to view related FDA registrations.