Identity
- Trade Name
- STRAUMANN GRANULES FDA UDI
- Generic Name
- Dental bone matrix implant, synthetic FDA UDI
- Device Name
- Straumann® BoneCeramic™ 400-700 micrometer, 0.25 g FDA UDI
- Model / Reference
- BoneCeramic FDA UDI
- Description
- Straumann® BoneCeramic™ 400-700 micrometer, 0.25 g FDA UDI
Identifiers
- Catalog Number
- 070.203 FDA UDI
- Primary DI / UDI-DI
- 07630031700155 FDA UDI
- 510(k) Number
- K040646 FDA UDI
- FDA Product Code
- LYC FDA UDI
- GMDN Term
- Dental bone matrix implant, synthetic FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3930 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 bone matrix implant, synthetic
Straumann Granules by Institut Straumann SA — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K040646 also covers:
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
- Institut Straumann SA
Sources (1)
- FDA UDI 220e7c04-e04f-40ce-a50b-5424df5238ee 38 fields · synced May 31, 2026