FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Bond Apatite
DI: 07290014838024
·
Model: HA-BB-Pack1
·
AUGMA BIOMATERIALS LTD
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Bond Apatite
- Primary DI
- 07290014838024
- Version / Model
- HA-BB-Pack1
- Company Name
- AUGMA BIOMATERIALS LTD
- Labeler DUNS
- 533432352
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-09-10
- Public Version
- 3
- Public Version Date
- 2025-03-25
- Public Version Status
- Update
- Public Device Record Key
- 3cc732ee-9a49-4285-bc95-54bff365bcd3
- Distribution End Date
- 2025-02-23
Device Description
A synthetic, osteoconductive, composite graft cement composed of Biphasic Calcium Sulfate and Hydroxyapatite granules. Bond Apatite functions as a scaffold for bone regeneration in dental procedures, and is intended to fill, augment, or reconstruct bony defects in the oral and maxillofacial region.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LYC | Bone Grafting Material, Synthetic | Dental | 872.3930 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 16966 | Synthetic bone graft | An artificial bone substitute used for structural bone replacement typically when bone is lost due to disease (e.g., osteoporosis) or injury. It consists mainly of porous and mesh ceramic materials that provide a framework for bone growth, or harvested sea coral that serves as an additive, extender, or provides a framework for bone growth. This is a single-use device. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 17290014838021 | GS1 | 6 | Not in Commercial Distribution | 2025-02-23 | |
| Primary | 07290014838024 | GS1 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 5 – 30 Degrees Celsius