Sympro

Basic Information

• Brand Name: Sympro
• Primary DI: J009670010000
• Version / Model: 67001000
• Catalog Number: 67001000
• Company Name: Renfert GmbH
• Labeler DUNS: 328502976
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-07-10
• Public Version: 1
• Public Version Date: 2023-07-18
• Public Version Status: New
• Public Device Record Key: e0f94c6c-f9d3-41b0-b459-d21afa313492

Device Description

Cleaning device for dental removable prostheses

Device Characteristics

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

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
JER	Cleaner, Denture, Mechanical	Dental	872.3530	1

GMDN Terms

Code	Name	Definition	Implantable	Status
35893	Denture cleaning container	A non-powered receptacle intended to be used to clean/rinse a denture or similar dental prosthesis (e.g., a bridge). It is in the form of a container intended to hold the denture, typically with a denture cleansing solution, which may be manually agitated. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	J009670010000	HIBCC

Storage Conditions

• Type: Storage Environment Humidity
• Temperature Range: 10 – 96 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: -4 – 140 Degrees Fahrenheit