FDA UDI
In Commercial Distribution
🇺🇸 United States
Osstem Implant Co.,Ltd.
DI: 08800000995762
·
Model: BeauTis Light S
·
Osstem Implant Co.,Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Osstem Implant Co.,Ltd.
- Primary DI
- 08800000995762
- Version / Model
- BeauTis Light S
- Company Name
- Osstem Implant Co.,Ltd.
- Labeler DUNS
- 694893867
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-11-30
- Public Version
- 1
- Public Version Date
- 2022-12-08
- Public Version Status
- New
- Public Device Record Key
- 2fcc7e7c-8f8f-4c5f-a389-3803065070c0
Device Description
The BeauTis Light S is a teeth whitening lamp that emits visible light to discolored teeth arter applying whitener in order to achieve whitening effect. The BeauTis Light S is a medical device that must be operated by medical personnel. The BeauTis Light S is classifiled as Class ll and Type BF applied part. The nornal maximum operation condition is 20 min operation, 5 min rest for BeauTis Light S
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- 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
- No
- PM Exempt
- Yes
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| EEG | Heat Source For Bleaching Teeth | Dental | 872.6475 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 31806 | Tooth-bleaching acceleration unit | A heat and/or light source intended to increase the oxidative effect of tooth bleachers (e.g., oxygen peroxide, carbamide peroxide, hydrogen peroxide) during tooth whitening dental procedures. It typically consists of a dedicated electromagnetic energy source (e.g., xenon lamp, LED), which may operate within a specific wavelength range, a laser, or an electric powered heater. The device is typically used during procedures in dental offices. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08800000995762 | GS1 |