AccessGUDID - DEVICE: Caulk® 34% Tooth Conditioner Gel Phosphoric Acid Gel (D0026461261)

GUDID

Device Identifier (DI) Information

Brand Name: Caulk® 34% Tooth Conditioner Gel Phosphoric Acid Gel
Version or Model: 646126
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 646126
Company Name: DENTSPLY INTERNATIONAL INC.

Primary DI Number: D0026461261
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 25
Labeler D-U-N-S® Number*: 083235549 *Terms of Use

Device Description: Disposable Applicator Tips for Caulk® 34% Tooth Conditioner Gel Syringe - Refill 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:	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?
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 dry.

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 25 Disposable Applicator Tips

Device Record Status

Public Device Record Key: cc99001e-6d7b-45d4-a07b-509390b58e4b
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 21, 2016