AccessGUDID - DEVICE: Inspire™ Esthetic Provisional Composite A2 (00359883003944)

GUDID

Device Identifier (DI) Information

Brand Name: Inspire™ Esthetic Provisional Composite A2
Version or Model: 152702
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 152702
Company Name: DEN-MAT HOLDINGS, LLC

Primary DI Number: 00359883003944
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 809857704 *Terms of Use

Device Description: Esthetic Provisional Composite

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?
45236	Temporary dental crown/bridge resin	A material [e.g., polymethylmethacrylate (PMMA)] intended to make a temporary crown or bridge prosthesis for use until a permanent restoration is fabricated.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EBG	CROWN AND BRIDGE, TEMPORARY, RESIN
EID	SYRINGE, RESTORATIVE AND IMPRESSION MATERIAL

FDA Premarket Submission

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

Device Exempt from Premarket Submission: No 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
Storage Environment Temperature: between 64 and 77 Degrees Fahrenheit
Storage Environment Temperature: between 18 and 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Weight: 71 Gram

Device Record Status

Public Device Record Key: 042ea7d2-51b0-444c-ab69-eccb3080c29f
Public Version Date: March 20, 2025
Public Version Number: 1
DI Record Publish Date: March 12, 2025