Identity
- Trade Name
- Osstem Implant Co.,Ltd. FDA UDI
- Generic Name
- Tooth-bleaching acceleration unit FDA UDI
- Device Name
- The BeauTis White Light is a teeth whitening lamp that emits visible light to discolored teeth arter applying whitener in order to achieve whitening effect. The BeauTis White Light is a medical device that can be used by male and female adults and can be operated by an individual. The BeauTis White Light is classifiled as Class ll and Type BF applied part. The nornal maximum operation condition is 5 min operation, 5 min rest for BeauTis White Light. The degree of protection against harmful ingress of water is IP21 FDA UDI
- Model / Reference
- BeauTis White Light FDA UDI
- Description
- The BeauTis White Light is a teeth whitening lamp that emits visible light to discolored teeth arter applying whitener in order to achieve whitening effect. The BeauTis White Light is a medical device that can be used by male and female adults and can be operated by an individual. The BeauTis White Light is classifiled as Class ll and Type BF applied part. The nornal maximum operation condition is 5 min operation, 5 min rest for BeauTis White Light. The degree of protection against harmful ingress of water is IP21 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800000995755 FDA UDI
- FDA Product Code
- EEG FDA UDI
- GMDN Term
- Tooth-bleaching acceleration unit FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.6475 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Tooth-bleaching acceleration unit
Osstem Implant Co., Ltd. by OSSTEM IMPLANT Co., Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- OSSTEM IMPLANT Co., Ltd.
Sources (1)
- FDA UDI 7007dc97-6040-4f53-b4ba-8daa8d398d53 33 fields · synced May 30, 2026