AccessGUDID - DEVICE: Dentsply Sirona (D0026263921)

GUDID

Device Identifier (DI) Information

Brand Name: Dentsply Sirona
Version or Model: 626392
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 626392
Company Name: DENTSPLY INTERNATIONAL INC.

Primary DI Number: D0026263921
Issuing Agency: HIBCC
Commercial Distribution End Date: January 25, 2024
Device Count: 6
Labeler D-U-N-S® Number*: 083235549 *Terms of Use

Device Description: Dentsply Sirona Intraoral Tip Sample Package

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):	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?
60366	Dental material injection cannula, single-use	A rigid or semi-rigid luminal device (dental tip) intended to channel and dispense a dental material/solution [e.g., restorative amalgam, resin, etching solution (etchant), topical dental anaesthetic] from a dental syringe, or similar applicator, to a patient’s teeth, oral mucosa, or gums; it is not intended to penetrate tissue (it is not a needle), not dedicated to root canal irrigation, and may be used for dental applications outside the patients mouth. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EJR	AGENT, POLISHING, ABRASIVE, ORAL CAVITY

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: Protect from moisture.
Special Storage Condition, Specify: Keep out of direct sunlight.
Storage Environment Temperature: between 10 and 24 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 6 Intraoral Tips

Device Record Status

Public Device Record Key: e41b713f-a893-49ed-bb89-1990abd8fa20
Public Version Date: February 29, 2024
Public Version Number: 4
DI Record Publish Date: August 24, 2022