Retainer, Screw Expansion, Orthodontic
The Orthodontic Screw Expansion Retainer is a dental device used in orthodontic treatment to gradually expand the dental arch or maintain corrected tooth positions by means of an adjustable screw mechanism embedded in a removable appliance. 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 DYJ and the applicable regulation is 21 CFR 872.5410, under the Dental medical specialty.
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Basic Information
- Product Code
- DYJ
- 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 5 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K970930 | BILATERAL INFANT CLEFT PALATE ORTHODONTIC APPLIANCE | Apr 23, 1997 | Substantially Equivalent | Cleft Palate Appliances, Inc. |
| K935154 | DENTAURUM EXPANSION SCREWS | Feb 03, 1994 | Substantially Equivalent | Dentauraum, Inc. |
| K925088 | EXPANSION SCREWS | May 22, 1993 | Substantially Equivalent | Forestadent |
| K912417 | MOLAR DISTALIZING ASSEMBLY | Dec 20, 1991 | Substantially Equivalent | American Orthodontics |
| K843705 | MANDIBULATOR JAW POSITIONER | Nov 14, 1984 | Substantially Equivalent | A Company, Inc. |
FEI Numbers
This FDA classification entry is associated with 120 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 120 registration numbers. Click on an entry to view related FDA registrations.