AccessGUDID - DEVICE: Porcelain Etchant (D757E5720E1)

GUDID

Device Identifier (DI) Information

Brand Name: Porcelain Etchant
Version or Model: E-5720E
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: E-5720E
Company Name: BISCO INC.

Primary DI Number: D757E5720E1
Issuing Agency: HIBCC
Commercial Distribution End Date: September 19, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 053529939 *Terms of Use

Device Description: Porcelain Etchant (4% HF) / Barrier Gel Set

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?
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
EIH	POWDER, PORCELAIN
EID	SYRINGE, RESTORATIVE AND IMPRESSION MATERIAL

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
Storage Environment Temperature: between 20 and 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 9ed90804-5f06-4975-8ba4-37279683416e
Public Version Date: September 20, 2022
Public Version Number: 5
DI Record Publish Date: June 12, 2017