ZMD-1000B TEMPORARY

GUDID 08806169157126

Dental Temporary Resin / ZMD-1000B TEMPORARY

DENTIS CO., LTD.

Dental crown/bridge resin, temporary
Primary Device ID08806169157126
NIH Device Record Key427ba89e-088a-40b9-8035-bfed0f0106f8
Commercial Distribution StatusIn Commercial Distribution
Brand NameZMD-1000B TEMPORARY
Version Model NumberZMD-1000B TEMPORARY
Company DUNS688204158
Company NameDENTIS CO., LTD.
Device Count1
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 Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108806169157126 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EBGCrown And Bridge, Temporary, Resin

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-06-04
Device Publish Date2019-05-27

Devices Manufactured by DENTIS CO., LTD.

08800053035163 - s-Clean SQ-SL Fixture2021-03-10 Dental Implant System / s-Clean SQ-SL Fixture (DSSFR5507)
08800053022385 - s-Clean SQ-SL Fixture2021-03-08 Dental Implant System / s-Clean SQ-SL Fixture (DSSFR5507)
08806169155979 - s-Clean SQ-SL Fixture2020-05-01 s-Clean SQ-SL Fixture / D4.1 X L7.0 mm
08806169155986 - s-Clean SQ-SL Fixture2020-05-01 s-Clean SQ-SL Fixture / D4.1mm X L7.5mm
08806169155993 - s-Clean SQ-SL Fixture2020-05-01 s-Clean SQ-SL Fixture / D4.1mm X L9.5mm
08806169156006 - s-Clean SQ-SL Fixture2020-05-01 s-Clean SQ-SL Fixture / D4.1mm X L11.5mm
08806169156013 - s-Clean SQ-SL Fixture2020-05-01 s-Clean SQ-SL Fixture / D4.1mm X L13.5mm
08806169156020 - s-Clean SQ-SL Fixture2020-05-01 s-Clean SQ-SL Fixture / D4.4mm X L7.0mm

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