AccessGUDID - DEVICE: Essentials by 3D Dental (00817169023906)

GUDID

Device Identifier (DI) Information

Brand Name: Essentials by 3D Dental
Version or Model: BRTQ
Commercial Distribution Status: In Commercial Distribution
Catalog Number: BRTQ
Company Name: 3D DENTAL DESIGNS AND DEVELOPMENT, LLC

Primary DI Number: 00817169023906
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 080194935 *Terms of Use

Device Description: BITE REGISTRATION TRAYS 35/BX QUADRANT

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):	Yes
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?
16350	Dental impression tray, single-use	A horseshoe-shaped receptacle made of metal or plastic designed to carry dental impression material to the mouth, to confine the material in opposition to the surfaces to be recorded (e.g., teeth and gums), and to control the impression material while it sets to form an impression. The device is used mainly to facilitate the manufacturing of custom dental prostheses (e.g., dentures). 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: 034812aa-1ee4-4fef-9b82-657a8e3c323a
Public Version Date: December 23, 2022
Public Version Number: 1
DI Record Publish Date: December 15, 2022