DEVICE: Bond Apatite (07290014838024)

Device Identifier (DI) Information

Bond Apatite
HA-BB-Pack1
In Commercial Distribution

AUGMA BIOMATERIALS LTD
07290014838024
GS1

1
533432352 *Terms of Use
Bond Apatite® is 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.‎
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
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No

GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
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.
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FDA Product Code

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Product Code Product Code Name
LYC Bone Grafting Material, Synthetic
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
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Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
Storage Environment Temperature: between 5 and 30 Degrees Celsius
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

3cc732ee-9a49-4285-bc95-54bff365bcd3
March 29, 2018
2
September 10, 2015
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
17290014838021 6 07290014838024 In Commercial Distribution
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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Yes
No
Yes
Yes
No CLOSE

Customer Contact

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No Customer Contact currently defined
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