AccessGUDID - DEVICE: SDR® flow+ Bulk Fill Flowable (D00261C111G1)

GUDID

Device Identifier (DI) Information

Brand Name: SDR® flow+ Bulk Fill Flowable
Version or Model: 61C111G
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 61C111G
Company Name: DENTSPLY INTERNATIONAL INC.

Primary DI Number: D00261C111G1
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 60
Labeler D-U-N-S® Number*: 083235549 *Terms of Use

Device Description: SDR® flow+ Syringe Tips Refill

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":	Yes
For Single-Use:	Yes
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?
58399	Dental material mixing nozzle	A device designed for mixing inactive compounds during a dental procedure to produce a functional dental restorative/impression material which may be applied directly to the oral cavity/teeth of the patient or used for some other dental application. It is nozzle-shaped and has an integral mixing mechanism (e.g., spiralled channels). It is attached to the end of a cartridge consisting of two tubes so that the compounds are mixed as they are expressed simultaneously from the tubes through the nozzle. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EBF	Material, tooth shade, 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
Storage Environment Temperature: between 2 and 24 Degrees Celsius
Special Storage Condition, Specify: Protect from moisture.
Special Storage Condition, Specify: Keep away from direct sunlight.

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 60 Syringe Tips

Device Record Status

Public Device Record Key: 9768591d-8b67-46fc-85a2-e0f92118475c
Public Version Date: February 03, 2023
Public Version Number: 2
DI Record Publish Date: August 16, 2022