Komet BioSeal Tips, 20 count

GUDID 00850008515224

Komet BioSeal Tips, 20 count

NUSMILE, LTD.

Endodontic filling/sealing material
Primary Device ID00850008515224
NIH Device Record Keybabe9fe3-e75a-42eb-98ca-906d7fb5b491
Commercial Distribution StatusIn Commercial Distribution
Brand NameKomet BioSeal Tips, 20 count
Version Model Number082010008220
Company DUNS185497372
Company NameNUSMILE, LTD.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Producttrue
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100850008515224 [Primary]

FDA Product Code

EICSyringe, Periodontic, Endodontic, Irrigating

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-09-14
Device Publish Date2020-09-04

Devices Manufactured by NUSMILE, LTD.

00810118105524 - NuSmile BioFlx Anterior Central and Lateral - Mini Kit 2024-08-22 NuSmile BioFlx Anterior Central and Lateral - Mini Kit - 20 Crowns
00810118105531 - NuSmile BioFlx Cuspid - Mini Kit2024-08-22 NuSmile BioFlx Cuspid - Mini Kit - 20 Crowns
00810118105548 - NuSmile BioFlx Narrow - First Primary Molar - Starter Kit 2024-08-22 NuSmile BioFlx Narrow - First Primary Molar - Starter Kit - 32 Crowns
00810118104565 - NuSmile Signature Anterior Replacement Crown 2024-06-21 NuSmile Signature Anterior Replacement Crown - Central, Size 1 Right - Regular Length / Light Shade
00810118104572 - NuSmile Signature Anterior Replacement Crown2024-06-21 NuSmile Signature Anterior Replacement Crown - Central, Size 2 Right - Regular Length / Light Shade
00810118104589 - NuSmile Signature Anterior Replacement Crown2024-06-21 NuSmile Signature Anterior Replacement Crown - Central, Size 3 Right - Regular Length / Light Shade
00810118104596 - NuSmile Signature Anterior Replacement Crown2024-06-21 NuSmile Signature Anterior Replacement Crown - Central, Size 4 Right - Regular Length / Light Shade
00810118104602 - NuSmile Signature Anterior Replacement Crown 2024-06-21 NuSmile Signature Anterior Replacement Crown - Central, Size 5 Right - Regular Length / Light Shade

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.