Fusion Bond DC 10005

GUDID D96710005

PREVEST DENPRO LIMITED

Dental acrylic resin kit
Primary Device IDD96710005
NIH Device Record Key84e0d4c3-9175-4cc1-b1a9-0902f83a65ec
Commercial Distribution StatusIn Commercial Distribution
Brand NameFusion Bond DC
Version Model NumberIntro Pack
Catalog Number10005
Company DUNS859546940
Company NamePREVEST DENPRO LIMITED
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 Usefalse
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
HIBCCD96710005 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KLEAgent, Tooth Bonding, Resin

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-05-01
Device Publish Date2024-04-23

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D967300160 - Zitemp2025-03-18
D9673001600 - Zitemp2025-03-18
D967200270 - Fusion Core DC Flo and Fusion Bond DC2025-02-18
D96710001 - Fusion Bond 7 2024-05-01
D96710002 - Fusion Bond 7 2024-05-01

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