SDR® flow+ Bulk Fill Flowable

Basic Information

• Brand Name: SDR® flow+ Bulk Fill Flowable
• Primary DI: D00261C111G1
• Version / Model: 61C111G
• Catalog Number: 61C111G
• Company Name: DENTSPLY INTERNATIONAL INC.
• Labeler DUNS: 083235549
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 60
• Record Status: Published
• Publish Date: 2022-08-16
• Public Version: 2
• Public Version Date: 2023-02-03
• Public Version Status: Update
• Public Device Record Key: 9768591d-8b67-46fc-85a2-e0f92118475c

Device Description

SDR® flow+ Syringe Tips Refill

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EBF	Material, tooth shade, resin	Dental	872.3690	2

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	D00261C111G0	HIBCC
Primary	D00261C111G1	HIBCC

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			60 Syringe Tips

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 24 Degrees Celsius
• Type: Special Storage Condition, Specify
• Special Conditions: Protect from moisture.
• Type: Special Storage Condition, Specify
• Special Conditions: Keep away from direct sunlight.