510(k) K183018
- Device
- VPro5
- Applicant
- Propel Orthodontics LLC
- 510(k) number
- K183018
- Product code
- OYH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2019-11-01
- Date received
- 2018-10-31
- Regulation
- 872.5470
- Classification name
- Orthodontic Vibratory Accessory
- Medical specialty
- Dental
- Review panel
- Dental
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Bryce Way
- Address
- 394 S. Abbott Ave. Milpitas CA US 95035 95035
FDA Registration Numbers#
- 2424472
- 2950160
- 3013423303
Source Documents#
Other 510(k) Records For Product Code OYH #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K170093 | AcceleDent Optima | Orthoaccel Technology, Inc. | 2017-05-26 |
| K153048 | AcceleDent Aura | Orthoaccel Technologies, Inc. | 2016-07-08 |
| K130643 | ACCELEDENT AURA | Orthoaccel Technologies, Inc. | 2013-04-23 |
| K110661 | ACCELEDENT | Orthoaccel Technologies, Inc. | 2011-11-17 |
Legacy Summary#
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FDA Review#
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