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: 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: 1x2cc FDA UDI
Primary DI / UDI-DI: 04260476431128 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: 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

Category: Dental bone matrix implant, synthetic

IngeniOS ß-TCP Bioactiv Synthetic Bone Particles by curasan AG — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Dental bone matrix implant, synthetic.

Cytrans Granules — Gc America Inc. · Class II
PuraFILL — COLLAGEN MATRIX, INC. · Class II
Dental Putty - 6 x 0.5cc — NovaBone Products, LLC · Class II
Dental Putty 2 x 1.5cc — NovaBone Products, LLC · Class II
PreservaRidge™ Plug — COLLAGEN MATRIX, INC. · Class II
PLENA PLUG — COLLAGEN MATRIX, INC. · Class II
PerioGlas 6 x 0.5cc — NovaBone Products, LLC · Class II
Dental Putty Syringe 2.0cc — NovaBone Products, LLC · Class II

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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: curasan AG

Sources (1)

FDA UDI 05561462-e1d7-4815-89a2-cf4347e9ad83 36 fields · synced Jun 1, 2026