AccessGUDID - DEVICE: All BOND 3 - PART B 6ml in Bag (D757B3602P1)

GUDID

Device Identifier (DI) Information

Brand Name: All BOND 3 - PART B 6ml in Bag
Version or Model: B-3602P
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: B-3602P
Company Name: BISCO INC.

Primary DI Number: D757B3602P1
Issuing Agency: HIBCC
Commercial Distribution End Date: January 01, 2021
Device Count: 1
Labeler D-U-N-S® Number*: 053529939 *Terms of Use

Device Description: No description.

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 [?]
K102844	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 20 and 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: sixe text

Device Record Status

Public Device Record Key: ab2c57d2-57ba-4b53-b775-c64778dcb866
Public Version Date: February 16, 2024
Public Version Number: 6
DI Record Publish Date: June 12, 2017