ZCORE™ EXPAND

GUDID D765ZXSOCKET0

Expandable Collagen-Enriched Porcine Xenograft (Socket), 5 mm x 17 mm

Osteogenics Biomedical Inc

Dental bone matrix implant, animal-derived
Primary Device IDD765ZXSOCKET0
NIH Device Record Key6135b422-5221-455e-aafe-bf008927bab0
Commercial Distribution StatusIn Commercial Distribution
Brand NameZCORE™ EXPAND
Version Model NumberZXSOCKET
Company DUNS123853058
Company NameOsteogenics Biomedical Inc
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Dimensions

Width5 Millimeter
Length17 Millimeter
Width5 Millimeter
Length17 Millimeter
Width5 Millimeter
Length17 Millimeter
Width5 Millimeter
Length17 Millimeter
Width5 Millimeter
Length17 Millimeter
Width5 Millimeter
Length17 Millimeter
Width5 Millimeter
Length17 Millimeter
Width5 Millimeter
Length17 Millimeter
Width5 Millimeter
Length17 Millimeter
Width5 Millimeter
Length17 Millimeter
Width5 Millimeter
Length17 Millimeter
Width5 Millimeter
Length17 Millimeter
Width5 Millimeter
Length17 Millimeter
Width5 Millimeter
Length17 Millimeter
Width5 Millimeter
Length17 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCD765ZXSOCKET0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NPMBone Grafting Material, Animal Source

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-07-05
Device Publish Date2021-06-25

On-Brand Devices [ZCORE™ EXPAND]

D765ZXSOCKET0Expandable Collagen-Enriched Porcine Xenograft (Socket), 5 mm x 17 mm
D765ZXSINUSS0Expandable Collagen-Enriched Porcine Xenograft (Small Sinus), 10 mm x 13 mm
D765ZXSINUSL0Expandable Collagen-Enriched Porcine Xenograft (Large Sinus), 12 mm x 17 mm

Trademark Results [ZCORE]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ZCORE
ZCORE
90382931 not registered Live/Pending
Arch Wood Protection, Inc.
2020-12-15
ZCORE
ZCORE
88610149 not registered Live/Pending
ZO Skin Health, Inc.
2019-09-09
ZCORE
ZCORE
86450363 5027746 Live/Registered
TEK Group International
2014-11-11
ZCORE
ZCORE
79277294 not registered Live/Pending
HITACHI CONSTRUCTION MACHINERY CO., LTD.
2019-10-07
ZCORE
ZCORE
78239197 2828031 Live/Registered
O'Brien Dental Lab, Inc.
2003-04-17

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