Avalon Biomed by Zarc Z-Fit Sterile Paper Points - Narrow 15

GUDID 00810118105654

180 units

NUSMILE, LTD.

Natural gutta-percha
Primary Device ID00810118105654
NIH Device Record Key3ec1a922-f28a-449a-a249-a9b79a515ec2
Commercial Distribution StatusIn Commercial Distribution
Brand NameAvalon Biomed by Zarc Z-Fit Sterile Paper Points - Narrow 15
Version Model NumberSCPP-701
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
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
GS100810118105654 [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 Date2025-02-06
Device Publish Date2025-01-29

Devices Manufactured by NUSMILE, LTD.

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00810118106453 - NuSmile NuNamel Pit & Fissure Sealant Brush Tip2025-08-01 NuNamel Pit & Fissure Sealant Brush Tip - 50 Pack
00810118106460 - NuSmile NuNamel Pit & Fissure Sealant2025-08-01 NuNamel Pit & Fissure Sealant 1 x 1.2 ml syringe + 15 tips Starter Kit
00810118106477 - NuSmile NuNamel Pit & Fissure Sealant2025-08-01 NuNamel Pit & Fissure Sealant 4 x 1.2 ml syringe + 20 tips Professional Kit
00810118106484 - NuSmile NuNamel Pit & Fissure Sealant2025-08-01 NuNamel Pit & Fissure Sealant 10 x 1.2 ml syringes (no tips) Value Kit
00810118106491 - Dentsply ProRoot BioSealer 2.2 g Kit, 20 Basic Flex Tips2025-07-23 Dentsply ProRoot BioSealer 2.2 g Kit, 20 Basic Flex Tips

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