Identity
- Trade Name
- ever GUIDE KIT FDA UDI
- Generic Name
- Dental/maxillofacial surgical procedure kit, non-medicated, reusable FDA UDI
- Device Name
- Dental Fixture is a kit consisting of dental implant surgical instruments required for surgery. FDA UDI
- Model / Reference
- EGK FDA UDI
- Description
- Dental Fixture is a kit consisting of dental implant surgical instruments required for surgery. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08806343922915 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
ever GUIDE KIT by Shinhung MST Co., Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Dental/maxillofacial surgical procedure kit, non-medicated, reusable.
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- Osteo KIT — OSSTEM IMPLANT Co., Ltd. · 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 |
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Manufacturer
- Manufacturer
- Shinhung MST Co., Ltd.
Sources (1)
- FDA UDI 470804bb-17fd-4563-aefa-96a6d1fb9996 34 fields · synced May 30, 2026