AccessGUDID - DEVICE: First Bite® Disposable Impression Trays (D0026612041)

GUDID

Device Identifier (DI) Information

Brand Name: First Bite® Disposable Impression Trays
Version or Model: 661204
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 661204
Company Name: DENTSPLY INTERNATIONAL INC.

Primary DI Number: D0026612041
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 30
Labeler D-U-N-S® Number*: 083235549 *Terms of Use

Device Description: First Bite® Disposable Impression Tray Refill - Full Arch

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":	Yes
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?
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
Special Storage Condition, Specify: Keep out of direct sunlight and protect from moisture.

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 30 Trays

Device Record Status

Public Device Record Key: dd9d87ba-3707-4942-8e1d-5f3c9d37d71b
Public Version Date: September 01, 2022
Public Version Number: 1
DI Record Publish Date: August 24, 2022