PerioGlas - 2 x 0.5cc ND0220

GUDID 00813909013527

Synthetic bone void filler for dental applications

NOVABONE PRODUCTS, LLC

Dental bone matrix implant, synthetic
Primary Device ID00813909013527
NIH Device Record Keya0e4f9dd-4a2c-41cb-b10c-a3ffdefbd54c
Commercial Distribution StatusIn Commercial Distribution
Brand NamePerioGlas - 2 x 0.5cc
Version Model NumberND0220
Catalog NumberND0220
Company DUNS828813290
Company NameNOVABONE PRODUCTS, LLC
Device Count2
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

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Device Identifiers

Device Issuing AgencyDevice ID
GS100813909013473 [Primary]
GS100813909013527 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LYCBone Grafting Material, Synthetic

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-05-05
Device Publish Date2025-04-25

On-Brand Devices [PerioGlas - 2 x 0.5cc]

00813909010618Synthetic bone void filler for dental applications
00813909013527Synthetic bone void filler for dental applications

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