Identity
- Trade Name
- IngeniOS ß-TCP Bioactiv Synthetic Bone Particles FDA UDI
- Generic Name
- Dental bone matrix implant, synthetic FDA UDI
- Device Name
- 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
- Model / Reference
- 0.25-1mm 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
- 42604764310366 FDA UDI
- 510(k) Number
- K103709 FDA UDI
- FDA Product Code
- LPK FDA UDI
- GMDN Term
- Dental bone matrix implant, synthetic FDA UDI
Classification
- Commercial Distribution
- Not 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
IngeniOS ß-TCP Bioactiv Synthetic Bone Particles by curasan AG — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K103709 also covers:
- IngeniOS ß-TCP Bioactiv Synthetic Bone Particles — curasan AG
- IngeniOS ß-TCP Bioactiv Synthetic Bone Particles — curasan AG
- IngeniOS ß-TCP Bioactiv Synthetic Bone Particles — curasan AG
- IngeniOS ß-TCP Bioactiv Synthetic Bone Particles — curasan AG
- IngeniOS ß-TCP Bioactiv Synthetic Bone Particles — curasan AG
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 | N/A | Pending data |
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Manufacturer
- Manufacturer
- curasan AG
Sources (1)
- FDA UDI 76defecd-6c23-4c9b-a078-37fd84363a0e 37 fields · synced Jun 1, 2026