AccessGUDID - DEVICE: Caulk® Orthodontic Resin (D0026510071)

GUDID

Device Identifier (DI) Information

Brand Name: Caulk® Orthodontic Resin
Version or Model: 651007
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 651007
Company Name: DENTSPLY INTERNATIONAL INC.

Primary DI Number: D0026510071
Issuing Agency: HIBCC
Commercial Distribution End Date: August 01, 2021
Device Count: 1
Labeler D-U-N-S® Number*: 083235549 *Terms of Use

Device Description: Caulk® Orthodonic Resin, Liquid, Pink, Regular 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":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	Yes
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
EBI	RESIN, DENTURE, RELINING, REPAIRING, REBASING

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 away from sunlight.

Clinically Relevant Size

[?]

Size Type Text
Weight: 605 Gram
Total Volume: 430 Milliliter
Device Size Text, specify: 1 Powder (605g), 1 Liquid-Pink (430mL), 1 Separator (65mL), 1 Liquid Dispenser (empty), Accessories

Device Record Status

Public Device Record Key: 236078f1-c743-4d51-a57c-8b780a3fc37c
Public Version Date: October 03, 2022
Public Version Number: 3
DI Record Publish Date: September 23, 2016