FDA.reportPublic FDA data

AOJ

Primary DI
00845717012843
Brand
AOJ
Company
Shenzhen AOJ Health Science & Technology Co., Ltd.
Model
USC-10
Published
2026-07-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

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
10845717012840PackageGS124In Commercial Distribution
00845717012843PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084571701284010845717012840
00845717012843008457170128438457170128430845717012843

GMDN Terms#

Term, Definition table
TermDefinition
Orthodontic appliance automated cleanerAn electromechanical device designed to clean soft debris, plaque and stain build-up from the surface of removable orthodontic aligners or retainers. The orthodontic appliances are typically placed in a receptacle and water together with an appropriate cleansing tablet or solution, and cleaned through an automated cycle. An audible signal may alert the user that the program has finished.

Regulatory Flags#

DUNS number
617069824
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850040296464AOJASP-4022026-07-11
06976313750014AOJBRP-3012026-06-03
06976313750021AOJBRP-3022026-06-03
06976313750212AOJBRP-3042026-06-03
06976313750229AOJBRP-3052026-06-03
06976313750236AOJBRP-3062026-06-03
06976313750649AOJBRP-3032026-06-03
06976313750656AOJBRP-3072026-06-03
06976313750663AOJBRP-3082026-06-03
06976313750038PATH PHARMASP-4012026-04-29
06976313750137PATH PHARMASP-4022026-04-29

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