Tube, Orthodontic
The Orthodontic Tube is a dental device, typically a small rectangular or round metal cylinder bonded to a molar tooth, through which an arch wire or facebow is inserted to provide anchorage and control of tooth movement 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 DZD and the applicable regulation is 21 CFR 872.5410, under the Dental medical specialty.
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Basic Information
- Product Code
- DZD
- 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 8 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K943421 | ORTHODONITC ELASTOMERIC SLEEVING | May 23, 1995 | Substantially Equivalent | Jon-Ko Products, Inc. |
| K936243 | REGENCY TUBE | Feb 02, 1994 | Substantially Equivalent | Ortho Specialties |
| K935143 | DENTAURUM STAINLESS STEEL TUBING | Jan 31, 1994 | Substantially Equivalent | Dentauraum, Inc. |
| K911399 | NASAL CPAP (CONTINUOUS POSITIVE AIR PRESSURE SYST) | Sep 19, 1991 | Substantially Equivalent | Aequitron Medical, Inc. |
| K896586 | RATE INCREASE FOR IPPB/IPV | Jan 09, 1990 | Substantially Equivalent | Percussionaire Corp. |
| K834446 | ALEXOTEK LINGUAL TUBES | Apr 05, 1984 | Substantially Equivalent | Alexotek Co. |
| K834392 | LABIAL CUSPID TUBE | Feb 28, 1984 | Substantially Equivalent | Alexotek Co. |
| K780205 | ORTHODONTIC BUCCAL TUBE | Feb 16, 1978 | Substantially Equivalent | Rocky Mountain Orthodontics, Inc. |
FEI Numbers
This FDA classification entry is associated with 112 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 112 registration numbers. Click on an entry to view related FDA registrations.