Primary Device ID | D8453003101 |
NIH Device Record Key | 0e603d81-0f20-4790-bd43-76f63c1c92a6 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Bite Occlusion Rims - Wax |
Version Model Number | 3003101 |
Catalog Number | 3003101 |
Company DUNS | 202016064 |
Company Name | Denplus Inc |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | true |
MRI Safety Status | MR Safe |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | true |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | false |
Expiration Date | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | true |
RX Perscription | false |
OTC Over-The-Counter | false |
Device Issuing Agency | Device ID |
---|---|
HIBCC | D8453003101 [Primary] |
EGD | Wax, Dental, Intraoral |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2021-09-29 |
Device Publish Date | 2021-09-21 |
D8451112100 - DP-Tray-R | 2021-09-29 DP-Tray-R. Liquid for Premium Tray, 240 ml |
D8451112200 - DP-Tray-R | 2021-09-29 DP-Tray-R, Liquid Regular, 1 l |
D8451121112 - Premium Tray | 2021-09-29 Cold-cured acrylic resin, White, 454 g |
D8451121113 - Premium Tray | 2021-09-29 Cold-cured acrylic resin, Yellow, 454 g |
D8451121114 - Premium Tray | 2021-09-29 Cold-cured acrylic resin, Pink, 454 g |
D8451121115 - Premium Tray | 2021-09-29 Cold-cured acrylic resin, Blue, 454 g |
D8451121212 - Premium Tray | 2021-09-29 Cold-cured acrylic resin, White, 2.3 kg |
D8451121213 - Premium Tray | 2021-09-29 Cold-cured acrylic resin, Yellow, 2.3 kg |