AccessGUDID - DEVICE: Prime&Bond active (D010606673411)

GUDID

Device Identifier (DI) Information

Brand Name: Prime&Bond active
Version or Model: 60667341
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 60667341
Company Name: Dentsply De Trey GmbH

Primary DI Number: D010606673411
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 315471722 *Terms of Use

Device Description: Prime&Bond active Standard Refill universal adhesive is a combined Etch&Rinse (Total Etch), Self Etch and Selective Etch adhesive. It offers a simple adhesive application technique for both direct and indirect indications and bonds to enamel, dentin, composites, zirconia and metals.

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?
34782	Dentine bonding agent/set	A material(s) primarily intended to be used as a bonding-promoting substance between dentine and a dental composite filling, restorative, or luting material; it may also be used as an enamel bonding material. It includes a resin-based bonding agent and may also include a primer, etching solution or curing activator, within the same formulation, or as part of a set. It is not a primer, etching solution and/or activator sold in the absence of a bonding agent; composite resin is not included. After application, this device cannot be reused.	Active	false

FDA Product Code

[?]

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

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
Storage Environment Temperature: between 2 and 24 Degrees Celsius
Special Storage Condition, Specify: Keep the product out of direct sunlight and store in a well-ventilated place.

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: liquid
Total Volume: 4 Milliliter

Device Record Status

Public Device Record Key: 198005ff-4734-4ebb-b572-a3fb0f012f7c
Public Version Date: February 16, 2024
Public Version Number: 2
DI Record Publish Date: November 15, 2018