Primary Device ID | D764B10731551 |
NIH Device Record Key | e9caa331-56b2-436a-b6b5-b657bbd2c945 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Intraoral Sensor Holder |
Version Model Number | B1073155 |
Company DUNS | 078613913 |
Company Name | SIRONA DENTAL, INC. |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | true |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | true |
Device Combination Product | false |
Single Use | true |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | true |
Expiration Date | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | false |
OTC Over-The-Counter | false |
Phone | 800.659.5977 |
imagingsupportus@dentsplysirona.com | |
Phone | 800.659.5977 |
imagingsupportus@dentsplysirona.com | |
Phone | 800.659.5977 |
imagingsupportus@dentsplysirona.com | |
Phone | 800.659.5977 |
imagingsupportus@dentsplysirona.com |
Device Issuing Agency | Device ID |
---|---|
HIBCC | D764B10731551 [Primary] |
EGZ | Holder, Film, X-Ray |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2022-12-15 |
Device Publish Date | 2022-12-07 |
D764B10731581 | Sirona Anterior Holder Assembly Kit - Blue |
D764B10731571 | Sirona Bitewing Holder Assembly Kit - Red |
D764B10731561 | Sirona Endo Holder Assy Kit |
D764B10731551 | Sirona Periapical Holder Assy Kit Yellow |
D764B10731531 | Sirona Endodontic Tab Assy Kit Green |