Zarc by Avalon Biomed Gutta Perch Obturator (Pellets)

GUDID 00810118103650

100 units

NUSMILE, LTD.

Natural gutta-percha
Primary Device ID00810118103650
NIH Device Record Key821b3006-b03c-4546-90bc-7f41129c8532
Commercial Distribution StatusIn Commercial Distribution
Brand NameZarc by Avalon Biomed Gutta Perch Obturator (Pellets)
Version Model Number6344003
Company DUNS185497372
Company NameNUSMILE, LTD.
Device Count1
DM Exempttrue
Pre-market Exempttrue
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 Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone832-540-5964
Emailplara@nusmile.com
Phone832-540-5964
Emailplara@nusmile.com
Phone832-540-5964
Emailplara@nusmile.com
Phone832-540-5964
Emailplara@nusmile.com
Phone832-540-5964
Emailplara@nusmile.com
Phone832-540-5964
Emailplara@nusmile.com
Phone832-540-5964
Emailplara@nusmile.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100810118103650 [Primary]

FDA Product Code

EKMGutta-Percha

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2026-01-23
Device Publish Date2026-01-15

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