PerioGlas 6 x 0.5cc ND0260

GUDID 00813909013534

Synthetic bone void filler for dental applications

NOVABONE PRODUCTS, LLC

Dental bone matrix implant, synthetic
Primary Device ID00813909013534
NIH Device Record Key2d1500a7-ff1f-417b-9a1d-911a0cf08664
Commercial Distribution StatusIn Commercial Distribution
Brand NamePerioGlas 6 x 0.5cc
Version Model NumberND0260
Catalog NumberND0260
Company DUNS828813290
Company NameNOVABONE PRODUCTS, LLC
Device Count6
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

Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS100813909013480 [Primary]
GS100813909013534 [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 6 x 0.5cc]

00813909010625Synthetic bone void filler for dental applications
00813909013534Synthetic bone void filler for dental applications

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.