AccessGUDID - DEVICE: IRM® Intermediate Restorative Material (D0026100071)

GUDID

Device Identifier (DI) Information

Brand Name: IRM® Intermediate Restorative Material
Version or Model: 610007
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 610007
Company Name: DENTSPLY INTERNATIONAL INC.

Primary DI Number: D0026100071
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 083235549 *Terms of Use

Device Description: IRM® Intermediate Restorative Material, Ivory, Standard Package

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:	Yes
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?
62200	Zinc oxide eugenol dental cement	A non-sterile, non-aqueous substance intended for professional use as a dental cement (e.g., luting agent, liner, base, pulp-capping material) and/or direct dental restorative material whereby the majority of the setting reaction is based on the hardening reaction between eugenol and zinc oxide (ZnO). It typically includes some additional fillers/components. After application, this device cannot be reused.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EMA	CEMENT, DENTAL

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: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Keep away from sunlight. Keep dry.

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Standard Package (Ivory): 1 Powder (38g), 1 Liquid (14mL)
Weight: 38 Gram
Total Volume: 14 Milliliter

Device Record Status

Public Device Record Key: 1f7601b7-6932-4733-96c8-6dc73258c5d1
Public Version Date: March 18, 2025
Public Version Number: 4
DI Record Publish Date: September 23, 2016