AccessGUDID - DEVICE: SpaceFile® (D74640035RSBL1)

GUDID

Device Identifier (DI) Information

Brand Name: SpaceFile®
Version or Model: 40035-RS-BL
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 40035-RS-BL
Company Name: DENTSPLY SIRONA ORTHODONTICS INC.

Primary DI Number: D74640035RSBL1
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 8
Labeler D-U-N-S® Number*: 116903307 *Terms of Use

Device Description: SpaceFile® IPR Strips-Right Sided-Medium/Blue

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
44730	Interproximal reduction kit	A collection of devices intended to be used for interproximal reduction (IPR), which is the reduction of contact between adjacent teeth during orthodontic alignment of the teeth. Fine abrasives are typically used to minimize pressure and allow the formation of spaces between the teeth, enabling more effective therapy without excessive interproximal contact, which may prolong or complicate teeth alignment. The device may include burs, abrasive disks, abrasive strips, thickness gauges and charts for tracking of reproximation. This device is reusable, but certain items will need to be replenished.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EHM	Strip, Polishing Agent

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: c79ed297-b3f1-48a5-8c4d-69b123371687
Public Version Date: March 25, 2024
Public Version Number: 6
DI Record Publish Date: December 16, 2021