Identity
- Trade Name
- Straumann XenoFlex FDA UDI
- Generic Name
- Dental bone matrix implant, animal-derived FDA UDI
- Device Name
- Straumann XenoFlex® is a combination of purified cancellous bone mineral granules (Straumann Xenograft®) and 10% collagen in a block form in a blister and cylindrical form in a syringe and blister. It is sterilized by γ- irradiation. FDA UDI
- Model / Reference
- NI-0110-025S FDA UDI
- Description
- Straumann XenoFlex® is a combination of purified cancellous bone mineral granules (Straumann Xenograft®) and 10% collagen in a block form in a blister and cylindrical form in a syringe and blister. It is sterilized by γ- irradiation. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08809186541794 FDA UDI
- 510(k) Number
- K142040 FDA UDI
- FDA Product Code
- NPM FDA UDI
- GMDN Term
- Dental bone matrix implant, animal-derived 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
Yes
FDA UDI
Dimensions & Sizes
- Size
- Weight — 0.25 Gram FDA UDI
Category: Dental bone matrix implant, animal-derived
Straumann XenoFlex by Nibec Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental bone matrix implant, animal-derived.
- MinerOss® X — ACE SURGICAL SUPPLY CO., INC. · Class II
- CevOss - CITAGENIX — ODONTIT S.A. · Class II
- naturesQue MaxOss P — COLLAGEN MATRIX, INC. · Class II
- BoneMedik-DM, 2~4mm, 5cc — Meta Biomed, Inc. · Class II
- MinerOss® X — ACE SURGICAL SUPPLY CO., INC. · Class II
- A-graft®[Bone grafting material, Animal source] — HIOSSEN INC. · Class II
- SYMBIOS — COLLAGEN MATRIX, INC. · Class II
- REGENX PuraXEN — ACE SURGICAL SUPPLY CO., INC. · Class II
Cleared under the same submission
K142040 also covers:
- Creos Xenogain Collagen — Nibec Co., Ltd.
- Creos Xenogain Collagen — Nibec Co., Ltd.
- Creos Xenogain Collagen — Nibec Co., Ltd.
- Creos Xenogain Collagen — Nibec Co., Ltd.
- Creos Xenogain Collagen — Nibec Co., Ltd.
- Creos Xenogain Collagen — Nibec Co., Ltd.
- OCS-B Collagen — Nibec Co., Ltd.
- OCS-B Collagen — Nibec Co., Ltd.
- OCS-B Collagen — Nibec Co., Ltd.
- OCS-B Collagen — Nibec Co., Ltd.
- OCS-B Collagen — Nibec Co., Ltd.
- OCS-B Collagen — Nibec Co., Ltd.
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 |
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Manufacturer
- Manufacturer
- Nibec Co., Ltd.
Sources (1)
- FDA UDI cc55c6b4-05ad-4313-b8fc-a1761199660c 37 fields · synced Jun 1, 2026