Primary Device ID | D00116146UPW232L0 |
NIH Device Record Key | 359c7b16-e9be-470b-bb0a-ae2447650d2e |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Portrait® IPN® 33 Deg. Posteriors |
Version Model Number | PW2 U 32L |
Catalog Number | 16146 |
Company DUNS | 606173334 |
Company Name | Dentsply International Inc. |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
MRI Safety Status | Labeling does not contain MRI Safety Information |
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 | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Phone | +1(800)243-1942 |
Prosthetics-Regulatory@dentsplysirona.com | |
Phone | +1(800)243-1942 |
Prosthetics-Regulatory@dentsplysirona.com | |
Phone | +1(800)243-1942 |
Prosthetics-Regulatory@dentsplysirona.com | |
Phone | +1(800)243-1942 |
Prosthetics-Regulatory@dentsplysirona.com | |
Phone | +1(800)243-1942 |
Prosthetics-Regulatory@dentsplysirona.com | |
Phone | +1(800)243-1942 |
Prosthetics-Regulatory@dentsplysirona.com | |
Phone | +1(800)243-1942 |
Prosthetics-Regulatory@dentsplysirona.com | |
Phone | +1(800)243-1942 |
Prosthetics-Regulatory@dentsplysirona.com | |
Phone | +1(800)243-1942 |
Prosthetics-Regulatory@dentsplysirona.com | |
Phone | +1(800)243-1942 |
Prosthetics-Regulatory@dentsplysirona.com | |
Phone | +1(800)243-1942 |
Prosthetics-Regulatory@dentsplysirona.com | |
Phone | +1(800)243-1942 |
Prosthetics-Regulatory@dentsplysirona.com | |
Phone | +1(800)243-1942 |
Prosthetics-Regulatory@dentsplysirona.com | |
Phone | +1(800)243-1942 |
Prosthetics-Regulatory@dentsplysirona.com |
Device Issuing Agency | Device ID |
---|---|
HIBCC | D00116146UPW232L0 [Primary] |
ELM | Denture, plastic, teeth |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 3 |
Public Version Date | 2024-11-08 |
Device Publish Date | 2016-09-21 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
PORTRAIT 98053376 not registered Live/Pending |
Zachary Miller 2023-06-21 |
PORTRAIT 97472759 not registered Live/Pending |
GE PRECISION HEALTHCARE LLC 2022-06-23 |
PORTRAIT 90524707 not registered Live/Pending |
BostonGene Corporation 2021-02-11 |
PORTRAIT 88976609 not registered Live/Pending |
EllaMD, Inc. 2019-07-30 |
PORTRAIT 88884728 not registered Live/Pending |
Lungarno Alberghi S.r.l. 2020-04-23 |
PORTRAIT 88673607 not registered Live/Pending |
GE PRECISION HEALTHCARE LLC 2019-10-30 |
PORTRAIT 88550372 not registered Live/Pending |
EllaMD, Inc. 2019-07-30 |
PORTRAIT 87925800 not registered Live/Pending |
Starkey Laboratories, Inc. 2018-05-17 |
PORTRAIT 87735324 not registered Dead/Abandoned |
Johnson, Phillip 2017-12-27 |
PORTRAIT 87397961 not registered Dead/Abandoned |
Cynosure, Inc. 2017-04-04 |
PORTRAIT 87381115 not registered Dead/Abandoned |
Canvas Talent, Inc. 2017-03-22 |
PORTRAIT 86931402 not registered Dead/Abandoned |
LIVETEXT, LLC 2016-03-07 |