AccessGUDID - DEVICE: Temp Silicon Brush (EMICTPENS1)

GUDID

Device Identifier (DI) Information

Brand Name: Temp Silicon Brush
Version or Model: TPENS
Commercial Distribution Status: In Commercial Distribution
Catalog Number: TPENS
Company Name: MICERIUM SPA

Primary DI Number: EMICTPENS1
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 436661136 *Terms of Use

Device Description: Temp Silicon Brush Silicon Brushes for composite application Brush tips, white small 5pcs Temp Silicon Brush INTRODUCTORY KIT TEMP BRUSHES white small soft 5 assorted bruhes Temp with silicon tip for the modellation of composite. Kit composed by: SS1 – S1 silicon tip short spatula shape for modelling occlusal surfaces. SS2 – S2 silicon tip long spatula shape for blending layers and shaping surfaces. SS3 – S3 silicon tip round-flat shape for modelling cervical areas. SS4 – S4 silicon tip cone shape point ideal for occlusal shaping. SS5 – S5 silicon tip with three sides for stains and characterizations.

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):	No
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?
63953	Dental material application tool, reusable	A hand-held manual dental instrument intended to be used for the application of a dental material (e.g., composite resin) to a dental prosthesis or to a patient’s tooth/teeth; the material is not included. It includes a handle with an application tip which holds the material on its surface; it is not a syringe- or pistol-like device. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EJB	Handle, Instrument, Dental

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Length: 14.7 Centimeter

Device Record Status

Public Device Record Key: 9fb7a604-0bde-4f8a-8879-8f6a4a88b174
Public Version Date: December 03, 2019
Public Version Number: 1
DI Record Publish Date: November 25, 2019