AccessGUDID - DEVICE: EdgeTemp Hydraulic Temporary Restorative (D858EETEMP0L)

GUDID

Device Identifier (DI) Information

Brand Name: EdgeTemp Hydraulic Temporary Restorative
Version or Model: EETEMP
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: EDGE ENDO LLC

Primary DI Number: D858EETEMP0L
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 078474365 *Terms of Use

Device Description: For fabrication of temporary fillings and other temporary prosthetics for use until the permanent prosthetic is ready for installation. Intended to restore carious lesions or structural defects in teeth temporarily. Intended for use in cavities Classes I, II, III, IV (inlays and onlays) and as a restorative material for veneers, crowns and bridges.

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?
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

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 10 and 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Weight: 40 Gram

Device Record Status

Public Device Record Key: 01513d29-63a1-4db6-9a48-c5db17cc87c2
Public Version Date: October 29, 2021
Public Version Number: 3
DI Record Publish Date: February 12, 2017