AccessGUDID - DEVICE: Megatray (EMD11MYDVOKS2)

GUDID

Device Identifier (DI) Information

Brand Name: Megatray
Version or Model: 2022/11/05
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: MEGADENTA Dentalprodukte GmbH

Primary DI Number: EMD11MYDVOKS2
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 316153928 *Terms of Use

Device Description: Light curing composite for the production of individual impression trays and base plates

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?
58106	Dental impression tray material	A material intended to be used to create a custom impression tray intended for filling with dental impression materials; it is not intended for the fabrication of a patient-worn dental appliance. The tray is typically made by applying the material to a preliminary plaster or stone model of the patient's teeth and gums. The material is used in cases in which a preformed impression tray is not suitable. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EBH	Material, Impression Tray, Resin

FDA Premarket Submission

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

Device Exempt from Premarket Submission: Yes 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: 2527f524-219a-4613-b92c-d252903df02a
Public Version Date: December 13, 2022
Public Version Number: 1
DI Record Publish Date: December 05, 2022

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Status
EMD11MYDVOKRS1	1	EMD11MYDVOKS2	In Commercial Distribution
EMD11MYDVOKBL1	1	EMD11MYDVOKS2	In Commercial Distribution
EMD11MYDVOKTR1	1	EMD11MYDVOKS2	In Commercial Distribution
EMD11MYDVOKRS11	1	EMD11MYDVOKS2	In Commercial Distribution