Maintainer, Space Preformed, Orthodontic
The Preformed Orthodontic Space Maintainer is a dental device placed in the mouth of a child following premature loss of a primary tooth to hold the space open and prevent adjacent teeth from drifting until the permanent tooth erupts. 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 DYT and the applicable regulation is 21 CFR 872.5525, under the Dental medical specialty.
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Basic Information
- Product Code
- DYT
- Device Class
- FDA class 1
- Regulation Number
- 872.5525
- 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 4 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K935856 | DENTAURUM SPACE MAINTAINER | Apr 28, 1994 | Substantially Equivalent | Dentauraum, Inc. |
| K864376 | FIBERBOND | Apr 07, 1987 | Substantially Equivalent | Dentec, Inc. |
| K812239 | UNITEK PALATAL BAR | Sep 21, 1981 | Substantially Equivalent | Unitek Corp. |
| K780814 | SAFETY STOP NECKSTRAP | Jun 30, 1978 | Substantially Equivalent | Northwest Orthodontics, Inc. |
FEI Numbers
This FDA classification entry is associated with 90 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 90 registration numbers. Click on an entry to view related FDA registrations.