DP-REPAIR 1061301

GUDID D8451061301

DP-REPAIR-R, SPL, 11.3 kg

Denplus Inc

Dental appliance fabrication material, cured
Primary Device IDD8451061301
NIH Device Record Key4f438c75-30e5-4ff4-bacb-94ad74fdc3e2
Commercial Distribution StatusIn Commercial Distribution
Brand NameDP-REPAIR
Version Model Number1061301
Catalog Number1061301
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
HIBCCD8451061301 [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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