AccessGUDID - DEVICE: flow.sil Assortment (EBRE540012700)

GUDID

Device Identifier (DI) Information

Brand Name: flow.sil Assortment
Version or Model: 54001270
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 54001270
Company Name: bredent GmbH & Co. KG

Primary DI Number: EBRE540012700
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 341086190 *Terms of Use

Device Description: flow.sil Assortment 10 parts 1 Assortment

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:	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?
17610	Denture reliner, soft, professional	A denture relining material used in dentistry by a dentist or dental laboratory technician that is applied as a permanent coating or lining on the base or tissue-contacting surface of a denture and which sets to a soft, plastic condition. Denture relining is defined as a process of providing a new fitting surface to a denture (ISO 1942-2, def 2.111). After application, this device cannot be reused.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EFX	PROTECTOR, SILICATE

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
No Device Sizes

Device Record Status

Public Device Record Key: 0c2f5069-c7e4-428c-a7eb-596df55ad54b
Public Version Date: September 15, 2023
Public Version Number: 1
DI Record Publish Date: September 07, 2023