DP97 1001116

GUDID D8451001116

DP97, ORI, 454 g

Denplus Inc

Dental appliance fabrication material, cured
Primary Device IDD8451001116
NIH Device Record Keyeae7be2b-e1fe-48c2-8427-97a677565572
Commercial Distribution StatusIn Commercial Distribution
Brand NameDP97
Version Model Number1001116
Catalog Number1001116
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
HIBCCD8451001116 [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 Date2018-04-30

On-Brand Devices [DP97]

D8451001316DP97, ORI, 11.3 kg
D8451001309DP97, Custom, 11.3 kg
D8451001307DP97, MDP, 11.3 kg
D8451001303DP97, RPI, 11.3 kg
D8451001302DP97, LPL, 11.3 kg
D8451001300DP97, CLR, 11.3kg
D8451001216DP97, ORI, 2.3 kg
D8451001207DP97, MDP, 2.3 kg
D8451001202DP97, LPL, 2.3 kg
D8451001200DP97, CLR, 2.3 kg
D8451001116DP97, ORI, 454 g
D8451001107DP97, MPD, 454 g
D8451001102DP97, LPL, 454 g
D8451001100DP97, CLR, 454 g

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