FDA UDI
In Commercial Distribution
🇺🇸 United States
Mavrik Dental System
DI: 07290113770164
·
Model: 01
·
Mavrik Dental System Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Mavrik Dental System
- Primary DI
- 07290113770164
- Version / Model
- 01
- Catalog Number
- 501-01430
- Company Name
- Mavrik Dental System Inc.
- Labeler DUNS
- 117776165
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-11-01
- Public Version
- 1
- Public Version Date
- 2023-11-09
- Public Version Status
- New
- Public Device Record Key
- e5de2908-5a1a-42e6-b0e7-4774d3fe1fe4
Device Description
Whitening MPU M
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| EEG | Heat Source For Bleaching Teeth | Dental | 872.6475 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63350 | Teeth whitening tray | A custom-made device intended to retain a bleaching agent for whitening natural teeth through bleaching. It is made of polymer materials in the form of a mould to fit precisely over the teeth for a specified patient. This is a single-patient reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07290113770164 | GS1 |