FDA.report

Newport Biologics Bone Graft Putty Mineral Collagen Composite

Primary DI
D74570BIOBGP050
Brand
Newport Biologics Bone Graft Putty Mineral Collagen Composite
Company
Prismatik Dentalcraft, Inc
Model
70-BIO-BGP05
Catalog number
70-BIO-BGP05
Device description
Bone Graft Putty Mineral Collagen Composite
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
LYCBone grafting material, synthetic

Product Code Classifications

CodeDeviceSpecialtyClass
LYCBone Grafting Material, SyntheticDental2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D74570BIOBGP050PrimaryHIBCC0

GMDN Terms

TermDefinition
Dental bone matrix implant, syntheticA sterile bioabsorbable device made of synthetic material implanted into the body to provide osteoconductive bone-tissue scaffolds to replace maxillofacial and/or mandibular bone lost through trauma or dental surgery. It is typically made of ceramics (e.g., tricalcium phosphate or hydroxyapatite), sometimes bioactive glasses or bioabsorbable polymers, and used to fill bone cavities and defects to promote the ingrowth of endogenous bone for skeletal reconstruction and/or augmentation. It is typically provided as sterile cancellous blocks, chips, or granules of varying sizes, or mouldable materials.

Device Sizes

TypeValueUnit
Device Size Text, specify0

Sterilization Methods

Method

Contacts

PhoneEmail
+1(949)440-2629Shelly.Harris@glidewelldental.com

Regulatory Flags

DUNS number
022761689
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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D745701161COM00050Inclusive®70-1161-COM000570-1161-COM00052025-12-01
D745701161COM00060Inclusive®70-1161-COM000670-1161-COM00062025-12-01
D745701161COM00080Inclusive®70-1161-COM000870-1161-COM00082025-12-01
D745701161COM00090Inclusive®70-1161-COM000970-1161-COM00092025-12-01
D745701161COM00100Inclusive®70-1161-COM001070-1161-COM00102025-12-01
D745701161COM00120Inclusive®70-1161-COM001270-1161-COM00122025-12-01
D745701161COM00130Inclusive®70-1161-COM001370-1161-COM00132025-12-01
D745701161COM00140Inclusive®70-1161-COM001470-1161-COM00142025-12-01
D745701161COM00160Inclusive®70-1161-COM001670-1161-COM00162025-12-01
D745701161COM00170Inclusive®70-1161-COM001770-1161-COM00172025-12-01
D745701161COM00180Inclusive®70-1161-COM001870-1161-COM00182025-12-01
D745701161COM00200Inclusive®70-1161-COM002070-1161-COM00202025-12-01
D745701161COM00210Inclusive®70-1161-COM002170-1161-COM00212025-12-01
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