Laminated Bite Wafers-Wax 3003102

GUDID D8453003102

Laminated Bite Wafers-Wax, White, 35 units

Denplus Inc

Bite registration rim wax
Primary Device IDD8453003102
NIH Device Record Key473ec03c-830c-4699-b944-5c042eb08a2e
Commercial Distribution StatusIn Commercial Distribution
Brand NameLaminated Bite Wafers-Wax
Version Model Number3003102
Catalog Number3003102
Company DUNS202016064
Company NameDenplus Inc
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusMR Safe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCD8453003102 [Primary]

FDA Product Code

EGDWax, Dental, Intraoral

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-09-29
Device Publish Date2021-09-21

Devices Manufactured by Denplus Inc

D8451112100 - DP-Tray-R2021-09-29 DP-Tray-R. Liquid for Premium Tray, 240 ml
D8451112200 - DP-Tray-R2021-09-29 DP-Tray-R, Liquid Regular, 1 l
D8451121112 - Premium Tray2021-09-29 Cold-cured acrylic resin, White, 454 g
D8451121113 - Premium Tray2021-09-29 Cold-cured acrylic resin, Yellow, 454 g
D8451121114 - Premium Tray2021-09-29 Cold-cured acrylic resin, Pink, 454 g
D8451121115 - Premium Tray2021-09-29 Cold-cured acrylic resin, Blue, 454 g
D8451121212 - Premium Tray2021-09-29 Cold-cured acrylic resin, White, 2.3 kg
D8451121213 - Premium Tray2021-09-29 Cold-cured acrylic resin, Yellow, 2.3 kg

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.