Identity
- Trade Name
- BioPlant FDA UDI
- Generic Name
- Synthetic bone graft FDA UDI
- Device Name
- Multipurpose Dental Bone Grafting Material FDA UDI
- Model / Reference
- 216132 FDA UDI
- Description
- Multipurpose Dental Bone Grafting Material FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00841396100048 FDA UDI
- 510(k) Number
- K050984 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
Dimensions & Sizes
- Size
- Weight — 0.5 Gram FDA UDI
Category: Synthetic bone graft
BioPlant by Kerr Corporation — 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
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- OsseoSculpt Moldable ABG, 3cc — Biogennix, LLC · Class II
- Montage Settable Bone Putty — ABYRX, INC. · Class II
- IngeniOS HA — curasan AG · Class II
- Osbone Dental — curasan AG · Class II
- Bicera® Resorbable Bone Substitute — WILTROM INC. · Class II
Cleared under the same submission
K050984 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 | Class II | Pending data |
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Manufacturer
- Manufacturer
- Kerr Corporation
Sources (1)
- FDA UDI bb668887-0ae8-4515-9f42-07a92f822b33 37 fields · synced Jun 8, 2026