Identity
- Trade Name
- IngeniOS HA FDA UDI
- Generic Name
- Synthetic bone graft FDA UDI
- Device Name
- Device Name: IngeniOS HA Indications for Use: Oral-maxillofacial surgery, dentistry, implantology, periodontology • Defects after removal of bone cysts • Augmentation of the atrophied alveolar ridge • Sinus floor elevation (subantral augmentation) • Filling of alveolar defects following tooth extraction for alveolar ridge preservation • Filling of extraction defects to create an implant bed • Filling of two or multi-walled infrabony pockets, and bi and trifurcation defects • Support function for a membrane in guided tissue regeneration (GTR) • Defects after surgical removal of retained teeth or corrective osteotomies • Other multi-walled bone defects of the alveolar ridge FDA UDI
- Model / Reference
- 1-2mm FDA UDI
- Description
- Device Name: IngeniOS HA Indications for Use: Oral-maxillofacial surgery, dentistry, implantology, periodontology • Defects after removal of bone cysts • Augmentation of the atrophied alveolar ridge • Sinus floor elevation (subantral augmentation) • Filling of alveolar defects following tooth extraction for alveolar ridge preservation • Filling of extraction defects to create an implant bed • Filling of two or multi-walled infrabony pockets, and bi and trifurcation defects • Support function for a membrane in guided tissue regeneration (GTR) • Defects after surgical removal of retained teeth or corrective osteotomies • Other multi-walled bone defects of the alveolar ridge FDA UDI
Identifiers
- Catalog Number
- 1x0.5cc FDA UDI
- Primary DI / UDI-DI
- 04260476431302 FDA UDI
- 510(k) Number
- K102872 FDA UDI
- FDA Product Code
- LYC FDA UDI
- GMDN Term
- Synthetic bone graft FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3930 FDA UDI
- Commercial Distribution
- 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
Category: Synthetic bone graft
IngeniOS HA by curasan AG — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Synthetic bone graft.
- Beta-bsm ® — Etex Corp. · Class II
- BIO2 TECHNOLOGIES — Bio2 Technologies, Inc. · Class II
- Bicera® Resorbable Bone Substitute — Wiltrom Co., Ltd. (Chutung) · Class II
- OsseoSculpt Moldable ABG, 3cc — Biogennix, LLC · Class II
- Montage Settable Bone Putty — ABYRX, INC. · Class II
- Bicera® Resorbable Bone Substitute — WILTROM INC. · Class II
- InQu — Isto Technologies, Inc. · Class II
- PURvital — Biogennix, LLC · Class II
Cleared under the same submission
K102872 also covers:
- IngeniOS HA — curasan AG
- IngeniOS HA — curasan AG
- IngeniOS HA — curasan AG
- IngeniOS HA — curasan AG
- IngeniOS HA — curasan AG
- IngeniOS HA — curasan AG
- Osbone Dental — curasan AG
- Osbone Dental — curasan AG
- Osbone Dental — curasan AG
- Osbone Dental — curasan AG
- Osbone Dental — curasan AG
- Osbone Dental — 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 | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- curasan AG
Sources (1)
- FDA UDI 16c35235-045b-48ca-8ab0-85c8142b5d26 36 fields · synced May 31, 2026