Identity
- Trade Name
- easy-graft CLASSIC EUDAMEDGUIDOR easy-graft CLASSIC FDA UDI
- Generic Name
- Dental bone matrix implant, synthetic FDA UDI
- Device Name
- in situ hardening synthetic bone graft system EUDAMEDin situ hardening synthetic bone graft system, 0.4 Milliliter FDA UDI
- Model / Reference
- C11-012 EUDAMEDC11-008 FDA UDI
- Description
- in situ hardening synthetic bone graft system, 0.4 Milliliter FDA UDI
Identifiers
- Catalog Number
- C11-008 FDA UDI
- Primary DI / UDI-DI
- 07640164360218 EUDAMED07640164360645 FDA UDI
- Basic UDI-DI
- B-07640164360218 EUDAMED
- 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
- Germany 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
Dimensions & Sizes
- Size
- Total Volume — 0.4 Milliliter FDA UDI
Category: Dental bone matrix implant, synthetic
GUIDOR easy-graft CLASSIC by Degradable Solutions AG — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Degradable Solutions AG
Sources (2)
- FDA UDI c44d526a-896e-4d6f-a24e-213e250eace7 36 fields · synced Jul 8, 2026
- EUDAMED bca349e4-3841-4167-924f-6f39d2b9cb1f 61 fields · synced Jul 8, 2026