AccessGUDID - DEVICE: Inspire™ Esthetic Provisional Composite A2 (07540172010511)

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: CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.

Primary DI Number: 07540172010511
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 626406016 *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):	No
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
EID	SYRINGE, RESTORATIVE AND IMPRESSION MATERIAL
EBG	CROWN AND BRIDGE, TEMPORARY, RESIN

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 18 and 25 Degrees Celsius
Storage Environment Temperature: between 64 and 77 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
Weight: 71 Gram
Device Size Text, specify: cartridge

Device Record Status

Public Device Record Key: 3aa33dc0-f994-41e8-baf8-965e65332280
Public Version Date: October 29, 2021
Public Version Number: 3
DI Record Publish Date: September 16, 2016