Primary Device ID | D8451001100 |
NIH Device Record Key | ca962f48-7102-4803-896a-cfb49656d622 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | DP97 |
Version Model Number | 1001100 |
Catalog Number | 100110 |
Company DUNS | 202016064 |
Company Name | Denplus Inc |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
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 | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Device Issuing Agency | Device ID |
---|---|
HIBCC | D8451001100 [Primary] |
EBI | Resin, Denture, Relining, Repairing, Rebasing |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 3 |
Public Version Date | 2018-07-06 |
Device Publish Date | 2018-04-30 |
D8451001316 | DP97, ORI, 11.3 kg |
D8451001309 | DP97, Custom, 11.3 kg |
D8451001307 | DP97, MDP, 11.3 kg |
D8451001303 | DP97, RPI, 11.3 kg |
D8451001302 | DP97, LPL, 11.3 kg |
D8451001300 | DP97, CLR, 11.3kg |
D8451001216 | DP97, ORI, 2.3 kg |
D8451001207 | DP97, MDP, 2.3 kg |
D8451001202 | DP97, LPL, 2.3 kg |
D8451001200 | DP97, CLR, 2.3 kg |
D8451001116 | DP97, ORI, 454 g |
D8451001107 | DP97, MPD, 454 g |
D8451001102 | DP97, LPL, 454 g |
D8451001100 | DP97, CLR, 454 g |