FDA UDI
In Commercial Distribution
🇺🇸 United States
Perio Sciences LED Tooth Whitener
DI: 00353238006208
·
Model: 10620
·
Perio Sciences, LLC
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Perio Sciences LED Tooth Whitener
- Primary DI
- 00353238006208
- Version / Model
- 10620
- Company Name
- Perio Sciences, LLC
- Labeler DUNS
- 961798605
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-02-08
- Public Version
- 1
- Public Version Date
- 2024-02-16
- Public Version Status
- New
- Public Device Record Key
- 5a84b9e2-46ad-488d-8208-5f48c11a0e39
Device Description
This device utilizes a tooth whitening tray which surrounds the teeth and holds a whitening formulation during the teeth whitening procedure. The whitening formulation is supplied in three single use pens. The device is fitted with blue and red LED lights to simultaneously help enhance the bleaching procedure and protect the gums and soft tissues.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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
- Yes
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| EHY | Tray, Impression, Preformed | Dental | 872.6880 | 1 |
| MAU | Eraser, Dental Stain | Dental | 872.6855 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46432 | Teeth whitening kit | A collection of devices intended to whiten natural teeth through bleaching. It typically includes a bleaching agent (e.g., a gel containing a low concentration of an oxidizing agent, such as carbamide peroxide or hydrogen peroxide), a syringe(s), a tray(s), a mouthguard, an applicator (e.g., a brush) and strips to apply/retain the bleaching agent to/on the teeth for a recommended period. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00353238006208 | GS1 |