SpaceFile® 40035-Y

GUDID D74640035Y0

SpaceFile® IPR Strips-Double Sided-X Fine/Yellow

DENTSPLY SIRONA ORTHODONTICS INC.

Dental abrasive strip, reusable

• Primary Device ID: D74640035Y0
• NIH Device Record Key: bfc44240-db4a-4427-ad57-1c8871fdad72
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SpaceFile®
• Version Model Number: 40035-Y
• Catalog Number: 40035-Y
• Company DUNS: 116903307
• Company Name: DENTSPLY SIRONA ORTHODONTICS INC.
• Device Count: 8
• 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

• Phone: +1(844)848-0137
• Email: essix.sales@dentsplysirona.com
• Phone: +1(844)848-0137
• Email: essix.sales@dentsplysirona.com
• Phone: +1(844)848-0137
• Email: essix.sales@dentsplysirona.com
• Phone: +1(844)848-0137
• Email: essix.sales@dentsplysirona.com
• Phone: +1(844)848-0137
• Email: essix.sales@dentsplysirona.com
• Phone: +1(844)848-0137
• Email: essix.sales@dentsplysirona.com
• Phone: +1(844)848-0137
• Email: essix.sales@dentsplysirona.com
• Phone: +1(844)848-0137
• Email: essix.sales@dentsplysirona.com
• Phone: +1(844)848-0137
• Email: essix.sales@dentsplysirona.com
• Phone: +1(844)848-0137
• Email: essix.sales@dentsplysirona.com
• Phone: +1(844)848-0137
• Email: essix.sales@dentsplysirona.com
• Phone: +1(844)848-0137
• Email: essix.sales@dentsplysirona.com
• Phone: +1(844)848-0137
• Email: essix.sales@dentsplysirona.com
• Phone: +1(844)848-0137
• Email: essix.sales@dentsplysirona.com
• Phone: +1(844)848-0137
• Email: essix.sales@dentsplysirona.com
• Phone: +1(844)848-0137
• Email: essix.sales@dentsplysirona.com
• Phone: +1(844)848-0137
• Email: essix.sales@dentsplysirona.com
• Phone: +1(844)848-0137
• Email: essix.sales@dentsplysirona.com
• Phone: +1(844)848-0137
• Email: essix.sales@dentsplysirona.com
• Phone: +1(844)848-0137
• Email: essix.sales@dentsplysirona.com
• Phone: +1(844)848-0137
• Email: essix.sales@dentsplysirona.com
• Phone: +1(844)848-0137
• Email: essix.sales@dentsplysirona.com
• Phone: +1(844)848-0137
• Email: essix.sales@dentsplysirona.com
• Phone: +1(844)848-0137
• Email: essix.sales@dentsplysirona.com
• Phone: +1(844)848-0137
• Email: essix.sales@dentsplysirona.com
• Phone: +1(844)848-0137
• Email: essix.sales@dentsplysirona.com
• Phone: +1(844)848-0137
• Email: essix.sales@dentsplysirona.com
• Phone: +1(844)848-0137
• Email: essix.sales@dentsplysirona.com
• Phone: +1(844)848-0137
• Email: essix.sales@dentsplysirona.com
• Phone: +1(844)848-0137
• Email: essix.sales@dentsplysirona.com
• Phone: +1(844)848-0137
• Email: essix.sales@dentsplysirona.com
• Phone: +1(844)848-0137
• Email: essix.sales@dentsplysirona.com
• Phone: +1(844)848-0137
• Email: essix.sales@dentsplysirona.com
• Phone: +1(844)848-0137
• Email: essix.sales@dentsplysirona.com
• Phone: +1(844)848-0137
• Email: essix.sales@dentsplysirona.com
• Phone: +1(844)848-0137
• Email: essix.sales@dentsplysirona.com
• Phone: +1(844)848-0137
• Email: essix.sales@dentsplysirona.com
• Phone: +1(844)848-0137
• Email: essix.sales@dentsplysirona.com
• Phone: +1(844)848-0137
• Email: essix.sales@dentsplysirona.com
• Phone: +1(844)848-0137
• Email: essix.sales@dentsplysirona.com
• Phone: +1(844)848-0137
• Email: essix.sales@dentsplysirona.com
• Phone: +1(844)848-0137
• Email: essix.sales@dentsplysirona.com
• Phone: +1(844)848-0137
• Email: essix.sales@dentsplysirona.com
• Phone: +1(844)848-0137
• Email: essix.sales@dentsplysirona.com
• Phone: +1(844)848-0137
• Email: essix.sales@dentsplysirona.com
• Phone: +1(844)848-0137
• Email: essix.sales@dentsplysirona.com
• Phone: +1(844)848-0137
• Email: essix.sales@dentsplysirona.com
• Phone: +1(844)848-0137
• Email: essix.sales@dentsplysirona.com
• Phone: +1(844)848-0137
• Email: essix.sales@dentsplysirona.com
• Phone: +1(844)848-0137
• Email: essix.sales@dentsplysirona.com
• Phone: +1(844)848-0137
• Email: essix.sales@dentsplysirona.com
• Phone: +1(844)848-0137
• Email: essix.sales@dentsplysirona.com
• Phone: +1(844)848-0137
• Email: essix.sales@dentsplysirona.com
• Phone: +1(844)848-0137
• Email: essix.sales@dentsplysirona.com
• Phone: +1(844)848-0137
• Email: essix.sales@dentsplysirona.com
• Phone: +1(844)848-0137
• Email: essix.sales@dentsplysirona.com
• Phone: +1(844)848-0137
• Email: essix.sales@dentsplysirona.com
• Phone: +1(844)848-0137
• Email: essix.sales@dentsplysirona.com
• Phone: +1(844)848-0137
• Email: essix.sales@dentsplysirona.com
• Phone: +1(844)848-0137
• Email: essix.sales@dentsplysirona.com
• Phone: +1(844)848-0137
• Email: essix.sales@dentsplysirona.com
• Phone: +1(844)848-0137
• Email: essix.sales@dentsplysirona.com
• Phone: +1(844)848-0137
• Email: essix.sales@dentsplysirona.com
• Phone: +1(844)848-0137
• Email: essix.sales@dentsplysirona.com
• Phone: +1(844)848-0137
• Email: essix.sales@dentsplysirona.com
• Phone: +1(844)848-0137
• Email: essix.sales@dentsplysirona.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D74640035Y0 [Unit of Use]
HIBCC	D74640035Y1 [Primary]

FDA Product Code

• EHM: Strip, Polishing Agent
• EJL: Bur, Dental

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[D74640035Y0]

Moist Heat or Steam Sterilization

[D74640035Y0]

Moist Heat or Steam Sterilization

[D74640035Y0]

Moist Heat or Steam Sterilization

[D74640035Y0]

Moist Heat or Steam Sterilization

[D74640035Y0]

Moist Heat or Steam Sterilization

[D74640035Y0]

Moist Heat or Steam Sterilization

[D74640035Y0]

Moist Heat or Steam Sterilization

[D74640035Y0]

Moist Heat or Steam Sterilization

[D74640035Y0]

Moist Heat or Steam Sterilization

[D74640035Y0]

Moist Heat or Steam Sterilization

[D74640035Y0]

Moist Heat or Steam Sterilization

[D74640035Y0]

Moist Heat or Steam Sterilization

[D74640035Y0]

Moist Heat or Steam Sterilization

[D74640035Y0]

Moist Heat or Steam Sterilization

[D74640035Y0]

Moist Heat or Steam Sterilization

[D74640035Y0]

Moist Heat or Steam Sterilization

[D74640035Y0]

Moist Heat or Steam Sterilization

[D74640035Y0]

Moist Heat or Steam Sterilization

[D74640035Y0]

Moist Heat or Steam Sterilization

[D74640035Y0]

Moist Heat or Steam Sterilization

[D74640035Y0]

Moist Heat or Steam Sterilization

[D74640035Y0]

Moist Heat or Steam Sterilization

[D74640035Y0]

Moist Heat or Steam Sterilization

[D74640035Y0]

Moist Heat or Steam Sterilization

[D74640035Y0]

Moist Heat or Steam Sterilization

[D74640035Y0]

Moist Heat or Steam Sterilization

[D74640035Y0]

Moist Heat or Steam Sterilization

[D74640035Y0]

Moist Heat or Steam Sterilization

[D74640035Y0]

Moist Heat or Steam Sterilization

[D74640035Y0]

Moist Heat or Steam Sterilization

[D74640035Y0]

Moist Heat or Steam Sterilization

[D74640035Y0]

Moist Heat or Steam Sterilization

[D74640035Y0]

Moist Heat or Steam Sterilization

[D74640035Y0]

Moist Heat or Steam Sterilization

[D74640035Y0]

Moist Heat or Steam Sterilization

[D74640035Y0]

Moist Heat or Steam Sterilization

[D74640035Y0]

Moist Heat or Steam Sterilization

[D74640035Y0]

Moist Heat or Steam Sterilization

[D74640035Y0]

Moist Heat or Steam Sterilization

[D74640035Y0]

Moist Heat or Steam Sterilization

[D74640035Y0]

Moist Heat or Steam Sterilization

[D74640035Y0]

Moist Heat or Steam Sterilization

[D74640035Y0]

Moist Heat or Steam Sterilization

[D74640035Y0]

Moist Heat or Steam Sterilization

[D74640035Y0]

Moist Heat or Steam Sterilization

[D74640035Y0]

Moist Heat or Steam Sterilization

[D74640035Y0]

Moist Heat or Steam Sterilization

[D74640035Y0]

Moist Heat or Steam Sterilization

[D74640035Y0]

Moist Heat or Steam Sterilization

[D74640035Y0]

Moist Heat or Steam Sterilization

[D74640035Y0]

Moist Heat or Steam Sterilization

[D74640035Y0]

Moist Heat or Steam Sterilization

[D74640035Y0]

Moist Heat or Steam Sterilization

[D74640035Y0]

Moist Heat or Steam Sterilization

[D74640035Y0]

Moist Heat or Steam Sterilization

[D74640035Y0]

Moist Heat or Steam Sterilization

[D74640035Y0]

Moist Heat or Steam Sterilization

[D74640035Y0]

Moist Heat or Steam Sterilization

[D74640035Y0]

Moist Heat or Steam Sterilization

[D74640035Y0]

Moist Heat or Steam Sterilization

[D74640035Y0]

Moist Heat or Steam Sterilization

[D74640035Y0]

Moist Heat or Steam Sterilization

[D74640035Y0]

Moist Heat or Steam Sterilization

[D74640035Y0]

Moist Heat or Steam Sterilization

[D74640035Y0]

Moist Heat or Steam Sterilization

[D74640035Y0]

Moist Heat or Steam Sterilization

[D74640035Y0]

Moist Heat or Steam Sterilization

[D74640035Y0]

Moist Heat or Steam Sterilization

[D74640035Y0]

Moist Heat or Steam Sterilization

[D74640035Y0]

Moist Heat or Steam Sterilization

[D74640035Y0]

Moist Heat or Steam Sterilization

[D74640035Y0]

Moist Heat or Steam Sterilization

[D74640035Y0]

Moist Heat or Steam Sterilization

[D74640035Y0]

Moist Heat or Steam Sterilization

[D74640035Y0]

Moist Heat or Steam Sterilization

[D74640035Y0]

Moist Heat or Steam Sterilization

[D74640035Y0]

Moist Heat or Steam Sterilization

[D74640035Y0]

Moist Heat or Steam Sterilization

[D74640035Y0]

Moist Heat or Steam Sterilization

[D74640035Y0]

Moist Heat or Steam Sterilization

[D74640035Y0]

Moist Heat or Steam Sterilization

[D74640035Y0]

Moist Heat or Steam Sterilization

[D74640035Y0]

Moist Heat or Steam Sterilization

[D74640035Y0]

Moist Heat or Steam Sterilization

[D74640035Y0]

Moist Heat or Steam Sterilization

[D74640035Y0]

Moist Heat or Steam Sterilization

[D74640035Y0]

Moist Heat or Steam Sterilization

[D74640035Y0]

Moist Heat or Steam Sterilization

[D74640035Y0]

Moist Heat or Steam Sterilization

[D74640035Y0]

Moist Heat or Steam Sterilization

[D74640035Y0]

Moist Heat or Steam Sterilization

[D74640035Y0]

Moist Heat or Steam Sterilization

[D74640035Y0]

Moist Heat or Steam Sterilization

[D74640035Y0]

Moist Heat or Steam Sterilization

[D74640035Y0]

Moist Heat or Steam Sterilization

[D74640035Y0]

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