AccessGUDID - DEVICE: Enamelite (H66851002141)

GUDID

Device Identifier (DI) Information

Brand Name: Enamelite
Version or Model: 5100214
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 5100214
Company Name: Keystone Industries

Primary DI Number: H66851002141
Issuing Agency: HIBCC
Commercial Distribution End Date: November 01, 2019
Device Count: 1
Labeler D-U-N-S® Number*: 073503117 *Terms of Use

Device Description: Aeropaque Z-Liner, Shade Clear Small

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?
16187	Dental appliance fabrication material, ceramic	A dental material made of ceramic materials (e.g., zirconium oxide) intended to be used to manufacture a final dental prosthesis (e.g., a dental implant, removable dentures, crown, bridge) for patient use. It is used to create implantable and removable restorations using manual or computer-aided design/computer-aided manufacturing (CAD/CAM) technology. After application, this material cannot be reused for fabrication.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EIH	POWDER, PORCELAIN

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
Special Storage Condition, Specify: Exposure to temps above 120°F may cause can to burst and cause injury
Special Storage Condition, Specify: avoid prolonged exposure to sunlight or heat from radiators, ovens or other heat sources
Special Storage Condition, Specify: store at room temperature

Clinically Relevant Size

[?]

Size Type Text
Weight: 110 Gram

Device Record Status

Public Device Record Key: 72a5d3a1-49fc-4a7d-8dda-2525e338e2c2
Public Version Date: November 06, 2023
Public Version Number: 6
DI Record Publish Date: September 15, 2016