Identity
- Trade Name
- SynthoGraft EUDAMEDFDA UDI
- Generic Name
- Dental bone matrix implant, synthetic FDA UDI
- Device Name
- Bone Graft EUDAMED0.5g SynthoGraft (500-1000um) FDA UDI
- Model / Reference
- 260-400-500 EUDAMEDFDA UDI
- Description
- 0.5g SynthoGraft (500-1000um) FDA UDI
Identifiers
- Catalog Number
- 260-400-500 FDA UDI
- Primary DI / UDI-DI
- 10813110026702 EUDAMEDFDA UDI
- Basic UDI-DI
- B-10813110026702 EUDAMED
- 510(k) Number
- K051091 FDA UDI
- FDA Product Code
- LYC FDA UDI
- EMDN Code
- Q010302 DENTAL GRAFT DEVICES EUDAMED
- GMDN Term
- Dental bone matrix implant, synthetic FDA UDI
Classification
- Device Class
- Class III EUDAMEDClass II FDA UDI
- Regulation Number
- 872.3930 FDA UDI
- Market of Registration
- Ireland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
SynthoGraft by Bicon, Llc — Class III — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-10813110026702 | Class III | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class III | Pending data |
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Manufacturer
- Manufacturer
- Bicon, LLC
- EUDAMED SRN
- US-MF-000002782
- Authorised Representative
- Bicon Europe Ltd IE-AR-000002497
Sources (2)
- EUDAMED d324935b-c18a-4838-8607-75a8f6b91f9f 61 fields · synced Jul 23, 2026
- FDA UDI 30051c9f-e92a-429d-a224-02124c787dab 36 fields · synced May 30, 2026