IngeniOS ß-TCP Bioactiv Synthetic Bone Particles

FDA UDI

by curasan AG

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
1-2mm 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: 1x0.5cc FDA UDI
Primary DI / UDI-DI: 42604764310120 FDA UDI
04260476431012 FDA UDI
04260476431104 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
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

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:

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 (3)

FDA UDI 24b47ea7-de7e-4522-9f69-9ebfd6569ff5 37 fields · synced Jun 8, 2026
FDA UDI a1ad9a3a-ed23-4c38-9571-f7766fd3d74d 36 fields · synced May 27, 2026
FDA UDI 1e716628-f75d-4d98-9d36-dd43d2791743 36 fields · synced May 27, 2026