AccessGUDID - DEVICE: Aidite 3D Printing Model Resin (06976459492014)

GUDID

Device Identifier (DI) Information

Brand Name: Aidite 3D Printing Model Resin
Version or Model: APMR01
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Aidite (Qinhuangdao) Technology Co., Ltd.

Primary DI Number: 06976459492014
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 529607549 *Terms of Use

Device Description: For making dental models

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):	No
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?
64556	Custom-made dental anatomy model	A dental device made of gypsum (e.g., plaster, dental stone) intended to be used as a replica (model) of a specific patient’s teeth and gums, to assist with a dental treatment-related procedure (e.g., production of a dental restoration, design of a teeth whitening tray). It is created via casting (i.e., taking the impression of the patient’s teeth/gums, pouring plaster into the impression, and then removing the impression). This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EHY	Tray, Impression, Preformed

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: 5431ab0a-dcdd-4262-ae56-33b4186a8043
Public Version Date: October 23, 2023
Public Version Number: 1
DI Record Publish Date: October 14, 2023