Identity
- Trade Name
- Surgical Kit FDA UDI
- Generic Name
- Dental/maxillofacial surgical procedure kit, non-medicated, reusable FDA UDI
- Device Name
- These instruments are surgical tools that are used to expect the direction and place of the implant, to measure the drilling hole depth and gingival height for selecting abutments according to gingival heights, and to insert the implant in the prepared implant site after drilling. FDA UDI
- Model / Reference
- STDK FDA UDI
- Description
- These instruments are surgical tools that are used to expect the direction and place of the implant, to measure the drilling hole depth and gingival height for selecting abutments according to gingival heights, and to insert the implant in the prepared implant site after drilling. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08806343921208 FDA UDI
- FDA Product Code
- EJB FDA UDI
- GMDN Term
- Dental/maxillofacial surgical procedure kit, non-medicated, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.4565 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
No
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Dental/maxillofacial surgical procedure kit, non-medicated, reusable
Surgical Kit by Shinhung MST 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
- Shinhung MST Co., Ltd.
Sources (1)
- FDA UDI 6b49f8da-5dfe-49cb-aabf-63eb60e74844 35 fields · synced May 30, 2026