Primary Device ID | D8451121113 |
NIH Device Record Key | 89882ae6-2fe4-4485-b1a2-1403a3f772d8 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Premium Tray |
Version Model Number | 1121113 |
Catalog Number | 1121113 |
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 | true |
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 | D8451121113 [Primary] |
EBH | Material, Impression Tray, Resin |
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 |
D8451121315 | Cold-Cured Acrylic Resin, Blue, 11.3 kg |
D8451121314 | Cold-cured acrylic resin, Pink, 11.3 kg |
D8451121313 | Cold-cured acrylic resin, Yellow, 11.3 kg |
D8451121312 | Cold-cured acrylic resin, White, 11.3 kg |
D8451121215 | Cold-cured acrylic resin, Blue, 2.3 kg |
D8451121214 | Cold-cured acrylic resin, Pink, 2.3 kg |
D8451121213 | Cold-cured acrylic resin, Yellow, 2.3 kg |
D8451121212 | Cold-cured acrylic resin, White, 2.3 kg |
D8451121115 | Cold-cured acrylic resin, Blue, 454 g |
D8451121114 | Cold-cured acrylic resin, Pink, 454 g |
D8451121113 | Cold-cured acrylic resin, Yellow, 454 g |
D8451121112 | Cold-cured acrylic resin, White, 454 g |