AccessGUDID - DEVICE: Caulk® 34% Tooth Conditioner Gel Phosphoric Acid Gel (D0026461251)

GUDID

Device Identifier (DI) Information

Brand Name: Caulk® 34% Tooth Conditioner Gel Phosphoric Acid Gel
Version or Model: 646125
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 646125
Company Name: DENTSPLY INTERNATIONAL INC.

Primary DI Number: D0026461251
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 2
Labeler D-U-N-S® Number*: 083235549 *Terms of Use

Device Description: Caulk® 34% Tooth Conditioner Gel 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?
36153	Dental etching solution	An acid solution, in liquid or gel form, intended to be used to create a retentive surface for a dental composite, adhesive, or a pit and fissure sealant. After application, this device cannot be reused.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EBF	MATERIAL, TOOTH SHADE, RESIN

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

Clinically Relevant Size

[?]

Size Type Text
Total Volume: 3 Milliliter
Device Size Text, specify: 2 Syringes Caulk® Tooth Conditioner Gel (3mL each) and 25 Applicator Tips

Device Record Status

Public Device Record Key: 24423c9d-93c5-4f66-a9cf-9da31de1927b
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 21, 2016