Identity
- Trade Name
- Z-40 FDA UDI
- Generic Name
- Dental implant system FDA UDI
- Device Name
- OsseoFuse Z-40 Zirconia Dental Implant FDA UDI
- Model / Reference
- Z-7510 FDA UDI
- Description
- OsseoFuse Z-40 Zirconia Dental Implant FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04710986431649 FDA UDI
- FDA Product Code
- NHA FDA UDIDZE FDA UDI
- GMDN Term
- Dental implant system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3630 FDA UDI872.3640 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Dental implant system
Discover the OsseoFuse Z-40, a cutting-edge zirconia dental implant system designed for precise and durable bone integration. Made with high-quality materials and state-of-the-art technology, this implant system is ideal for complex cases where traditional methods may not be sufficient.
Similar devices
Also classified as Dental implant system.
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- Implant Regular — BIO CONCEPT Co., Ltd. · Class II
- TRI — Tri Dental Implants Int. AG · Class II
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 II | Pending data |
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Manufacturer
- Manufacturer
- Coho Biomedical Technology Co., Ltd.
Sources (1)
- FDA UDI d8454148-a7cd-48a1-add2-e1079632210a 33 fields · synced Jul 21, 2026