SpaceFile®
GUDID D74640034LS0
SpaceFile® IPR Strips-Left Sided Assorted
DENTSPLY SIRONA ORTHODONTICS INC.
Dental abrasive strip, reusable| Primary Device ID | D74640034LS0 |
| NIH Device Record Key | fb287395-8c1b-4ed2-beda-13d200dd05d6 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SpaceFile® |
| Version Model Number | 40034-LS |
| Company DUNS | 116903307 |
| Company Name | DENTSPLY SIRONA ORTHODONTICS INC. |
| Device Count | 9 |
| DM Exempt | true |
| Pre-market Exempt | true |
| 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 |
Customer Support Contacts
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | D74640034LS0 [Unit of Use] |
| HIBCC | D74640034LS1 [Primary] |
FDA Product Code
| EHM | Strip, Polishing Agent |
| EJL | Bur, Dental |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[D74640034LS0]
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[D74640034LS0]
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[D74640034LS0]
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[D74640034LS0]
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[D74640034LS0]
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[D74640034LS0]
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[D74640034LS0]
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[D74640034LS0]
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[D74640034LS0]
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[D74640034LS0]
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[D74640034LS0]
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[D74640034LS0]
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[D74640034LS0]
Moist Heat or Steam Sterilization
[D74640034LS0]
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[D74640034LS0]
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[D74640034LS0]
Moist Heat or Steam Sterilization
[D74640034LS0]
Moist Heat or Steam Sterilization
[D74640034LS0]
Moist Heat or Steam Sterilization
[D74640034LS0]
Moist Heat or Steam Sterilization
[D74640034LS0]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-12-24 |
| Device Publish Date | 2021-12-16 |
On-Brand Devices [SpaceFile®]
| 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 |
Trademark Results [SpaceFile]
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 |
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