Voodoo Clear Aligners
- Primary DI
- 00860000937801
- Brand
- Voodoo Clear Aligners
- Company
- VOODOO MANUFACTURING, INC.
- Model
- 1
- Device description
- Voodoo Clear Aligners are clear orthodontic aligners prescribed by a clinician to treat malocclusion. The patient follows a set treatment plan designed by the provider or a third party and that produces a series of steps (or trays) that are then worn by the patient. The clinician provides periodic checkups to make sure treatment is progressing appropriately.
- Published
- 2019-07-09
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- Single use
- true
Contact Domains#
Product Codes#
| Code | Name |
|---|---|
| NXC | Aligner, Sequential |
Product Code Classifications#
| Code | Device | Specialty | Class |
|---|---|---|---|
| NXC | Aligner, Sequential | Dental | 2 |
Premarket Submissions#
| Submission | Supplement |
|---|---|
| K190948 | 000 |
Premarket Details#
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 00860000937801 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|---|---|---|
| 00860000937801 | 00860000937801 | 860000937801 | 0860000937801 |
GMDN Terms#
| Term | Definition |
|---|---|
| Orthodontic appliance system, progressive | A series of preformed teeth aligners or positioners, worn in succession and changed every few weeks, designed to influence the shape and/or function of the stomatognathic system; often used to impact a patient's appearance and self image. It is typically custom-made using computer-generated modelling based on an initial oral impression, and a consultation with an orthodontist. It is typically made of a clear hard plastic, e.g., a thermoformed polycarbonate (PC). It is typically used to correct malocclusions such as underbites, overbites, cross bites and open bites, or crooked teeth and various other flaws of teeth and jaws, whether cosmetic or structural. This is a single-use device. |
Sterilization Methods#
| Method |
|---|
Contacts#
| Phone | |
|---|---|
| 6468544329 | support@voodoomfg.com |
Regulatory Flags#
- DUNS number
- 079975026
- Device count
- 1
- Serial number
- true
- Manufacturing date on label
- true
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