AccessGUDID - DEVICE: Prime&Bond Elect® Universal Dental Adhesive (D0026346001)

GUDID

Device Identifier (DI) Information

Brand Name: Prime&Bond Elect® Universal Dental Adhesive
Version or Model: 634600
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 634600
Company Name: DENTSPLY INTERNATIONAL INC.

Primary DI Number: D0026346001
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 083235549 *Terms of Use

Device Description: Prime&Bond® Elect Universal Dental Adhesive Dual Cure Intro Kit

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:	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?
42483	Dentine adhesive	A material primarily used as a bonding-promoting substance between dentine and a composite filling, restorative or luting material. It may also be used as a bonding substance to enamel. After application, this device cannot be reused.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
KLE	AGENT, TOOTH BONDING, RESIN

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K041343	000
K051463	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
Storage Environment Temperature: between 2 and 8 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Total Volume: 5 Milliliter
Total Volume: 4.5 Milliliter
Device Size Text, specify: 1 Bottle Adhesive, 1 Syringe Tooth Conditioner Gel, 25 Disposable Applicator Tips, 1 Bottle Activator, 50 Flocked Applicator Tips, 1 Dispensing Well

Device Record Status

Public Device Record Key: 1c2e3ba2-0747-4f58-b26a-cdc8d570d581
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 21, 2016