Primary Device ID | D74640027ANG1 |
NIH Device Record Key | 47e2ec4b-bcc4-4245-9c78-f73eba55e6ef |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | SpaceFile® |
Version Model Number | 40027ANG |
Catalog Number | 40027ANG |
Company DUNS | 116903307 |
Company Name | DENTSPLY SIRONA ORTHODONTICS INC. |
Device Count | 1 |
DM Exempt | true |
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 | false |
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 | true |
OTC Over-The-Counter | false |
Device Issuing Agency | Device ID |
---|---|
HIBCC | D74640027ANG1 [Primary] |
EGS | Handpiece, contra- and right-angle attachment, dental |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2021-05-10 |
Device Publish Date | 2021-05-01 |
D74640035GRIP1 | SpaceFile® Grip |
D74640027MOT1 | SpaceFile® Air Motor |
D74640027ANG1 | SpaceFile® Contra-angle Handpiece |
D74640035Y0 | SpaceFile® IPR Strips-Double Sided-X Fine/Yellow |
D74640035W0 | SpaceFile® IPR Strips-Double Sided-XX Fine/White |
D74640035RSY0 | SpaceFile® IPR Strips-Right Sided-X Fine/Yellow |
D74640035RSW0 | SpaceFile® IPR Strips-Right Sided-XX Fine/White |
D74640035RSR0 | SpaceFile® IPR Strips-Right Sided-Fine/Red |
D74640035RSP0 | SpaceFile®IPR Strips-R Sided-Finishing/Purple |
D74640035RSGR0 | SpaceFile® IPR Strips-Right Sided-Coarse/Green |
D74640035RSG0 | SpaceFile® IPR Strips-Right Sided-Polishing/Gray |
D74640035RSBLK0 | SpaceFile®IPR Strips-Right Sided-X Coarse/Black |
D74640035RSBL0 | SpaceFile® IPR Strips-Right Sided-Medium/Blue |
D74640035R0 | SpaceFile® IPR Strips-Double Sided-Fine/Red |
D74640035P0 | SpaceFile® IPR Strips-Dbl Sided-Finishing/Purple |
D74640035LSY0 | SpaceFile® IPR Strips-Left Sided-X Fine/Yellow |
D74640035LSW0 | SpaceFile® IPR Strips-Left Sided-XX Fine/White |
D74640035LSR0 | SpaceFile® IPR Strips-Left Sided-Fine/Red |
D74640035LSP0 | SpaceFile® IPR Strips-L Sided-Finishing/Purple |
D74640035LSGR0 | SpaceFile® IPR Strips-Left Sided-Coarse/Green |
D74640035LSG0 | SpaceFile® IPR Strips-Left Sided-Polishing/Gray |
D74640035LSBLK0 | SpaceFile®IPR Strips-Left Sided-X-Coarse/Black |
D74640035LSBL0 | SpaceFile® IPR Strips-Left Sided-Medium/Blue |
D74640035GR0 | SpaceFile®IPR Strips-Dbl Sided-Coarse/Green |
D74640035G0 | SpaceFile®IPR Strips-Dbl Sided-Polishing/Gray |
D74640035CS0 | SpaceFile®IPR Coping Saw /Gold (Brown) |
D74640035BLK0 | SpaceFile®IPR Strips-Dbl Sided-X Coarse Black |
D74640035BL0 | SpaceFile®IPR Strips-Dbl Sided-Medium/Blue |
D74640034RS0 | SpaceFile® IPR Strips-Right Sided Assorted |
D74640034LS0 | SpaceFile® IPR Strips-Left Sided Assorted |
D746400340 | SpaceFile®IPR Strips-Double Sided Assorted Pk 9 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
SPACEFILE 78316270 3000821 Live/Registered |
Spacefile International Corp. 2003-10-21 |
SPACEFILE 77845791 4175989 Live/Registered |
DENTSPLY SIRONA ORTHODONTICS INC. 2009-10-09 |