FDA.reportPublic FDA data

Sympro

Primary DI
J009670010000
Brand
Sympro
Company
Renfert GmbH
Model
67001000
Catalog number
67001000
Device description
Cleaning device for dental removable prostheses
Published
2023-07-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
JERCleaner, Denture, Mechanical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JERCleaner, Denture, MechanicalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
J009670010000PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Denture cleaning containerA 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity10 Percent (%) Relative Humidity96 Percent (%) Relative Humidity
Storage Environment Temperature-4 Degrees Fahrenheit140 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
328502976
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
J00925620010000Dynamix Speed 2256200100025620010002023-07-10
J00927610010000DUOMIX II276100100027610010002023-07-10
J00927700010000PROMIX one277000100027700010002023-07-10
J009600010000SYMPRESS60001000600010002023-07-10
J009610010000SYMPRESS II61001000610010002023-07-10
J009660000000temp:ex66000000660000002023-07-10
J009670000000help:ex plaque p67000000670000002023-07-10
J009670000010help:ex plaque p, sample67000001670000012023-07-10
J009670001000help:ex plaque f67000100670001002023-07-10
J009670002000help:ex discolor f67000200670002002023-07-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840456201336JMUJMU DENTAL, INCJER2026-08-18
00840456201343JMUJMU DENTAL, INCJER2026-08-18
00840456201350JMUJMU DENTAL, INCJER2026-08-18
00840456201367JMUJMU DENTAL, INCJER2026-08-18
00840456201374JMUJMU DENTAL, INCJER2026-08-18
00840456201381JMUJMU DENTAL, INCJER2026-08-18
00840456201398JMUJMU DENTAL, INCJER2026-08-18
00840456201404JMUJMU DENTAL, INCJER2026-08-18
00840456201411JMUJMU DENTAL, INCJER2026-08-18
00840456216477JMUJMU DENTAL, INCJER2026-08-18
00840456216484JMUJMU DENTAL, INCJER2026-08-18
00840456216491JMUJMU DENTAL, INCJER2026-08-18
00840456223819JMUJMU DENTAL, INCJER2026-08-18
00840456223826JMUJMU DENTAL, INCJER2026-08-18
00840456223833JMUJMU DENTAL, INCJER2026-08-18
00840456223840JMUJMU DENTAL, INCJER2026-08-18
00840456223857JMUJMU DENTAL, INCJER2026-08-18
00840456223864JMUJMU DENTAL, INCJER2026-08-18
00840456223871JMUJMU DENTAL, INCJER2026-08-18
00840456223888JMUJMU DENTAL, INCJER2026-08-18
00840456223895JMUJMU DENTAL, INCJER2026-08-18
00840456223901JMUJMU DENTAL, INCJER2026-08-18
00840456223918JMUJMU DENTAL, INCJER2026-08-18
00840456223925JMUJMU DENTAL, INCJER2026-08-18
00840456223932JMUJMU DENTAL, INCJER2026-08-18
00840456223949JMUJMU DENTAL, INCJER2026-08-18
00840456223956JMUJMU DENTAL, INCJER2026-08-18
00840456223963JMUJMU DENTAL, INCJER2026-08-18
00840456223970JMUJMU DENTAL, INCJER2026-08-18
00840456223987JMUJMU DENTAL, INCJER2026-08-18