Komet BioSeal Tips, 20 count

GUDID 00850008515224

Komet BioSeal Tips, 20 count

NUSMILE, LTD.

Endodontic filling/sealing material Endodontic filling/sealing material Endodontic filling/sealing material Endodontic filling/sealing material Endodontic filling/sealing material Endodontic filling/sealing material Endodontic filling/sealing material Endodontic filling/sealing material Endodontic filling/sealing material Endodontic filling/sealing material Endodontic filling/sealing material Endodontic filling/sealing material Endodontic filling/sealing material 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]
GS100850008515224 [Primary]
GS100850008515224 [Primary]
GS100850008515224 [Primary]
GS100850008515224 [Primary]
GS100850008515224 [Primary]
GS100850008515224 [Primary]
GS100850008515224 [Primary]
GS100850008515224 [Primary]
GS100850008515224 [Primary]
GS100850008515224 [Primary]
GS100850008515224 [Primary]
GS100850008515224 [Primary]
GS100850008515224 [Primary]

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.

00850008515200 - Avalon Biomed NeoSEALER Flo Tips2020-09-14 Avalon Biomed NeoSEALER Flo Tips
00850008515224 - Komet BioSeal Tips, 20 count2020-09-14Komet BioSeal Tips, 20 count
00850008515224 - Komet BioSeal Tips, 20 count2020-09-14 Komet BioSeal Tips, 20 count
00850008515231 - Komet BioSeal Starter Kit 2.2 gm2020-09-14 Design for root canal sealing Ruth gutta percha
00850008515217 - Flex Flo Tips2020-08-05 NeoSEALER Flex Flo Tips
00850008515163 - MTAFlow White 2.0 gm Powder2020-07-28 Indicated for dental procedures that contact pulp and periradicular tissues, as well as obturation and sealing root canals.
00850008515170 - MTAFlow White 2.0 ml Gel2020-07-28 Indicated for dental procedures that contact pulp and periradicular tissues, as well as obturation and sealing root canals.
00850008515187 - MTAFlow Powder 2.0 gm (Version 2)2020-07-28 Indicated for dental procedures that contact pulp and periradicular tissues, as well as obturation and sealing root canals.
00850008515194 - MTAFlow Gel 2.0 gm (Version 2)2020-07-28 Indicated for dental procedures that contact pulp and periradicular tissues, as well as obturation and sealing root canals.

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.