Taiwan FDA registration 50f4354a6b672c6949aae72373e03c13
“Osstem” SMARTbuilder System
TW: “歐詩汀”斯美特系統
Taiwan·Risk Class 2·MD·OSSTEM Implant Co., Ltd.·Registered Mar 09, 2017 – Mar 09, 2027ActiveRegistration details
- Analysis ID
- 50f4354a6b672c6949aae72373e03c13
- License Form
- Ministry of Health Medical Device Import No. 029373
- Customs Code
- DHA05602937300
Company information
- Manufacturer
- OSSTEM Implant Co., Ltd.
- Manufacturer Country
- Korea, Republic of
- Authorized Representative
- OSSTEM CORPORATION
Product details
- Intended Use
- This product is a metal device used with dental implants for bone graft fixation and support in alveolar bone defects.
- Product Type (Level 1)
- F Dental devices
- Product Type (Level 2)
- F4760 bone plate
- Import Information
- Imported from abroad
Dates and status
- Registration Date
- Mar 09, 2017
- Expiry Date
- Mar 09, 2027
About this record
Access comprehensive regulatory information for “Osstem” SMARTbuilder System in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 50f4354a6b672c6949aae72373e03c13 and manufactured by OSSTEM Implant Co., Ltd.. The authorized representative in Taiwan is OSSTEM CORPORATION.
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