FDA.report

ZCORE FORM

Primary DI
D765ZF2000
Brand
ZCORE FORM
Company
Osteogenics Biomedical Inc
Model
ZF200
Device description
Moldable Collagen-Enriched Porcine Xenograft, Particle Size 0.25-1.0 mm, Sterile, Contents: 2.0 cc
Published
2021-03-12
Public version status
New
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

Product Codes

CodeName
NPMBone Grafting Material, Animal Source

Product Code Classifications

CodeDeviceSpecialtyClass
NPMBone Grafting Material, Animal SourceDental2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D765ZF2000PrimaryHIBCC0

GMDN Terms

TermDefinition
Dental bone matrix implant, animal-derivedA sterile bioabsorbable device made primarily of animal-derived bone or dentin matrix (e.g., bovine, porcine) 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 used to fill bone cavities and defects and contains pores that 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.

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature59 Degrees Fahrenheit86 Degrees Fahrenheit

Sterilization Methods

Method

Regulatory Flags

DUNS number
123853058
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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D765GC3019P751X-Gut™ Chromic Gut SutureGC3019P752025-09-01
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D765GP3024751X-Gut™ Plain Gut SutureGP3024752025-09-01
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D765GP4019751X-Gut™ Plain Gut SutureGP4019752025-09-01
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D765ZXSOCKET101ZCORE™ EXPANDZXSOCKET-102025-04-14
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