DP-REPAIR 1071309

GUDID D8451071309

DP-REPAIR-F, CUSTOM, 11.3 kg

Denplus Inc

Dental appliance fabrication material, cured
Primary Device IDD8451071309
NIH Device Record Keyc511491d-cbd5-4fd2-ab18-9157ead639d4
Commercial Distribution StatusIn Commercial Distribution
Brand NameDP-REPAIR
Version Model Number1071309
Catalog Number1071309
Company DUNS202016064
Company NameDenplus Inc
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Safe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
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
HIBCCD8451071309 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EBIResin, Denture, Relining, Repairing, Rebasing

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2018-05-02

On-Brand Devices [DP-REPAIR]

D8451071316DP-REPAIR-F, ORI, 11.3 kg
D8451071309DP-REPAIR-F, CUSTOM, 11.3 kg
D8451071307DP-REPAIR-F, MDP, 11.3 kg
D8451071305DP-REPAIR-F, LPI, 11.3 kg
D8451071304DP-REPAIR-F, SPI, 11.3 kg
D8451071303DP-REPAIR-F, RPI, 11.3 kg
D8451071302DP-REPAIR-F, LPL, 11.3 kg
D8451071301DP-REPAIR-F, SPL, 11.3 kg
D8451071300DP-REPAIR-F, CLR, 11.3 kg
D8451071216DP-REPAIR-F, ORI, 2.3 kg
D8451071207DP-REPAIR-F, MDP, 2.3 kg
D8451071205DP-REPAIR-F, LPI, 2.3 kg
D8451071204DP-REPAIR-F, SPI, 2.3 kg
D8451071203DP-REPAIR-F, RPI, 2.3 KG
D8451071202DP-REPAIR-F, LPL, 2.3 kg
D8451071201DP-REPAIR-F, SPL, 2.3 kg
D8451071200DP-REPAIR-F, CLR, 2.3 kg
D8451071116DP-REPAIR-F, ORI, 454 g
D8451071107DP-REPAIR-F, MDP, 454 g
D8451071105DP-REPAIR-F, LPI, 454 g
D8451071104DP-REPAIR-F, SPI, 454 g
D8451071103DP-REPAIR-F, RPI, 454 g
D8451071102DP-REPAIR-F, LPL, 454 g
D8451071101DP-REPAIR-F, SPL, 454 g
D8451071100DP-REPAIR-F, CLR, 454 g
D8451062200LIQUID DP-REPAIR, 1 L
D8451062100LIQUID DP-REPAIR, 250 ml
D8451061316DP-REPAIR-R, ORI, 11.3 kg
D8451061309DP-REPAIR-R, CUSTOM, 11.3 kg
D8451061307DP-REPAIR-R, MDP, 11.3 kg
D8451061305DP-REPAIR, LPI, 11.3 kg
D8451061304DP-REPAIR-R, SPI, 11.3 kg
D8451061303DP-REPAIR-R, RPI, 11.3 kg
D8451061302DP-REPAIR-R, LPL, 11.3 kg
D8451061301DP-REPAIR-R, SPL, 11.3 kg
D8451061300DP-REPAIR-R, CLR, 11.3 kg
D8451061216DP-REPAIR-R, ORI, 2.3 kg
D8451061207DP-REPAIR-R, MDP, 2.3 kg
D8451061205DP-REPAIR-R, LPI, 2.3 kg
D8451061204DP-REPAIR-R, SPI, 2.3 kg
D8451061203DP-REPAIR-R, RPI, 2.3 kg
D8451061202DP-REPAIR-R, LPL, 2.3 kg
D8451061201DP-REPAIR-R, SPL, 2.3 kg
D8451061200DP-REPAIR-R, CLR, 2.3 kg
D8451061116DP-REPAIR-R, ORI, 454 g
D8451061107DP-REPAIR-R, MDP, 454 g
D8451061105DP-REPAIR-R, LPI, 454 g
D8451061104DP-REPAIR-R, SPI, 454 g
D8451061103DP-REPAIR-R, RPI, 454 g
D8451061102DP-REPAIR-R, LPL, 454 g
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