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IngeniOS ß-TCP Bioactiv Synthetic Bone Particles
FDA UDIEUDAMEDRef 0-602001Model IngeniOs® β-TCP Bioactive
by curasan AG
Identity
- Trade Name
- IngeniOs® β-TCP Bioactive EUDAMEDIngeniOS ß-TCP Bioactiv Synthetic Bone Particles FDA UDI
- Generic Name
- Dental bone matrix implant, synthetic FDA UDI
- Device Name
- IngeniOs® β-TCP Bioactive EUDAMEDDevice Name: IngeniOS ß-TCP Bioactiv Synthetic Bone Particles Indications for Use: Oral and maxillofacial surgery and dentistry • Augmentation or reconstructive treatment of the alveolar ridge • Filling of infrabony periodontal defects • Filling of defects after root resection, apicoectomy, and cystectomy • Filing of extraction sockets to enhance preservation of the alveolar ridge • Elevation of the maxillary sinus floor FDA UDI
- Model / Reference
- IngeniOs® β-TCP Bioactive EUDAMED0-602001 EUDAMED0.25-1mm FDA UDI
- Description
- Device Name: IngeniOS ß-TCP Bioactiv Synthetic Bone Particles Indications for Use: Oral and maxillofacial surgery and dentistry • Augmentation or reconstructive treatment of the alveolar ridge • Filling of infrabony periodontal defects • Filling of defects after root resection, apicoectomy, and cystectomy • Filing of extraction sockets to enhance preservation of the alveolar ridge • Elevation of the maxillary sinus floor FDA UDI
Identifiers
- Catalog Number
- 1x2cc FDA UDI
- Primary DI / UDI-DI
- 04260476431036 EUDAMEDFDA UDI
- Basic UDI-DI
- B-04260476431036 EUDAMED
- 510(k) Number
- K103709 FDA UDI
- FDA Product Code
- LPK FDA UDI
- EMDN Code
- P900402 RESORBABLE FILLING AND RECONSTRUCTION DEVICES EUDAMED
- GMDN Term
- Dental bone matrix implant, synthetic FDA UDI
Classification
- Device Class
- Class III EUDAMED
- 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
Category: Dental bone matrix implant, synthetic
IngeniOS ß-TCP Bioactiv Synthetic Bone Particles by curasan AG — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Cleared under the same submission
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 | — | N/A | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | N/A | Pending data |
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Manufacturer
- Manufacturer
- curasan AG
Sources (2)
- FDA UDI cad4bcd8-7e6a-4b7b-9af5-4143e6393a70 36 fields · synced Jul 8, 2026
- EUDAMED 372ef7f5-a0c1-4512-aaa1-7ca7fca9293e 61 fields · synced Jul 8, 2026