Identity
- Trade Name
- Osstem Implant Co.,Ltd. FDA UDI
- Generic Name
- Tooth-bleaching acceleration unit FDA UDI
- Device Name
- 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 FDA UDI
- Model / Reference
- BeauTis Light S FDA UDI
- 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 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800000995762 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
Yes
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
Similar devices
Also classified as Tooth-bleaching acceleration unit.
- AHVTE — FOSHAN OUSIDUN PERSONAL CARE PRODUCTS CO., LTD · Class I
- AHVTE — FOSHAN OUSIDUN PERSONAL CARE PRODUCTS CO., LTD · Class I
- Colgate Optic White Professional In Office Whitening Kit — COLGATE ORAL PHARMACEUTICALS, INC. · Class I
- Colgate Optic White Professional Take-Home Whitening Kit — COLGATE ORAL PHARMACEUTICALS, INC. · Class I
- Aladdin — DXM CO., LTD · Class I
- Philips Zoom — Discus Dental, Inc. · Class I
- AHVTE — FOSHAN OUSIDUN PERSONAL CARE PRODUCTS CO., LTD · Class I
- BEYOND® II Whitening Accelerator — Beyond International Inc. · Class I
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- OSSTEM IMPLANT Co., Ltd.
Sources (1)
- FDA UDI 2fcc7e7c-8f8f-4c5f-a389-3803065070c0 33 fields · synced May 30, 2026