AccessGUDID - DEVICE: JET SET-4 TOOTH SHADE POWDER (D65038H0CLR0)

GUDID

Device Identifier (DI) Information

Brand Name: JET SET-4 TOOTH SHADE POWDER
Version or Model: 250 GRAM SHADE CLEAR
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 38H0CLR
Company Name: LANG DENTAL MANUFACTURING CO., INC.

Primary DI Number: D65038H0CLR0
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 005185798 *Terms of Use

Device Description: VERY FAST CURING PROVISIONAL CROWN & BRIDE ACRYLIC RESIN POWDER

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:	Yes
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 [?]
K083195	000

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 14ce2071-4994-4c2f-9997-711f1b26287c
Public Version Date: October 29, 2021
Public Version Number: 4
DI Record Publish Date: September 01, 2016