AccessGUDID - DEVICE: BENCO (00366975001917)

GUDID

Device Identifier (DI) Information

Brand Name: BENCO
Version or Model: 3630-402
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: BENCO DENTAL SUPPLY CO.

Primary DI Number: 00366975001917
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 015108087 *Terms of Use

Device Description: BENCO ETCH GEL 37% 25ML REF BX2

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 Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
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.

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: 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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Total Volume: 25 Milliliter

Device Record Status

Public Device Record Key: 69fa0168-bf58-488a-a456-5a649da6bb25
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 23, 2016