AccessGUDID - DEVICE: Integrity® Temporary Crown & Bridge Material mini-SYRINGE (D0026663500)

GUDID

Device Identifier (DI) Information

Brand Name: Integrity® Temporary Crown & Bridge Material mini-SYRINGE
Version or Model: 666350
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 666350
Company Name: DENTSPLY INTERNATIONAL INC.

Primary DI Number: D0026663500
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 083235549 *Terms of Use

Device Description: Integrity® Temporary Crown and Bridge Material, A1, mini-SYRINGE Refill

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:	No
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?
31783	Temporary dental crown/bridge	A prosthetic dental device intended to temporarily replace the top of a tooth or a group of teeth until a permanent restoration is fabricated. The device is typically made of plastic material [e.g., polymethylmethacrylate (PMMA)].	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EBG	CROWN AND BRIDGE, TEMPORARY, RESIN

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K013674	000

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: Keep away from sunlight. Keep dry.
Storage Environment Temperature: between 10 and 24 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Weight: 15 Gram
Device Size Text, specify: 1 mini-Syringe (15g), 10 mini-Syringe Mixing Tips

Device Record Status

Public Device Record Key: 210fe06f-4bbb-45b0-9ece-d17083ba7569
Public Version Date: April 29, 2024
Public Version Number: 4
DI Record Publish Date: September 21, 2016