AccessGUDID - DEVICE: Solventum™ Filtek™ (00197998327667)

GUDID

Device Identifier (DI) Information

Brand Name: Solventum™ Filtek™
Version or Model: 12012014
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 12012014
Company Name: TOP-Service für Lingualtechnik GmbH

Primary DI Number: 00197998327667
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 315518329 *Terms of Use

Device Description: Solventum™ Filtek™ Composite Warmer Kit, 100-240V NA

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?
65223	Dental material heater	An electrically-powered device designed to be used to heat, through conduction, a variety of materials/substances (e.g., composite resin, root canal cleaning solution, local anaesthetic agent) to facilitate application of the material (e.g., optimum performance, patient comfort) during a dental procedure. It consists of a heating element with a temperature controller and a heater plate.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
QGO	Composite resin warmer

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: 77ef1585-be1c-46fa-b70f-a872cc19a4b6
Public Version Date: April 11, 2025
Public Version Number: 1
DI Record Publish Date: April 03, 2025