FDA.reportPublic FDA data

Angel Aligner

Primary DI
06956748709443
Brand
Angel Aligner
Company
Wuxi EA Medical Instruments Technologies Limited.
Model
EAB II
Published
2026-02-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
NXZDental Hygiene Kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NXZDental Hygiene KitDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06956748709443PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06956748709443069567487094436956748709443

GMDN Terms#

Term, Definition table
TermDefinition
Oral care kit, reusableA collection of various devices and supplies used for a patient's oral hygiene. It typically includes an antiseptic applicator swab, a pre-treated toothbrush, mouth swabs, and a mouthwash/oral moisturizer. It's use will improve the physical condition of the oral cavity and may help reduce the incidence of patient infection. It is typically applied by nursing staff in hospitals and institutions, or attendants in home care settings. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
421315681
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06956748704417Angel AlignerEAB II2026-05-19
06956748704394LUMOSCOEAB II2026-05-12
06956748704400LUMOSCORetainer2026-05-12
06956748700198Angel AlignerEAB II2026-05-06
06956748700761Angel AlignerEAB II2026-02-04
06956748701621IMPRESSEAB II2026-02-04
06956748701669ProgressiveEAB II2026-02-04
06956748701997OrthoArchEAB II2026-02-04
06956748702000OrthoArchEAB II2026-02-04
06956748702055Angel AlignerEAB II2026-02-04
06956748702062Angel AlignerEAB II2026-02-04
06956748702147Angel AlignerEAB II2026-02-04
06956748702390SimplyClearEAB II2026-02-04
06956748702406SimplyClearEAB II2026-02-04
06956748709429Angel AlignerEAB II2026-02-04
06956748709436Angel AlignerEAB II2026-02-04
06956748701614IMPRESSEAB II2023-12-06
06956748701270angel alignerEAB II2023-06-25
06956748700495angel aligner ClassicEAB II2022-06-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B23931150Plak-VacTRADEMARK MEDICAL, L.L.C.NXZ2026-01-08
B23931151Plak-VacTRADEMARK MEDICAL, L.L.C.NXZ2026-01-08
00850035489055Oral Relief KitzOrthonu LLCNXZ2025-04-27
B23930870Plak-VacTRADEMARK MEDICAL, L.L.C.NXZ2024-09-09
B23930871Plak-VacTRADEMARK MEDICAL, L.L.C.NXZ2024-09-09
B23931080Plak-VacTRADEMARK MEDICAL, L.L.C.NXZ2024-08-12
B23931081Plak-VacTRADEMARK MEDICAL, L.L.C.NXZ2024-08-12
B23931060Plak-VacTRADEMARK MEDICAL, L.L.C.NXZ2024-08-05
B23931070Plak-VacTRADEMARK MEDICAL, L.L.C.NXZ2024-08-05
B23931061Plak-VacTRADEMARK MEDICAL, L.L.C.NXZ2024-08-05
B23931071Plak-VacTRADEMARK MEDICAL, L.L.C.NXZ2024-08-05
B23930020Plak-VacTRADEMARK MEDICAL, L.L.C.NXZ2024-07-18
B23931020Plak-VacTRADEMARK MEDICAL, L.L.C.NXZ2024-07-18
B23931050Plak-VacTRADEMARK MEDICAL, L.L.C.NXZ2024-07-18
B23930021Plak-VacTRADEMARK MEDICAL, L.L.C.NXZ2024-07-18
B23931021Plak-VacTRADEMARK MEDICAL, L.L.C.NXZ2024-07-18
B23931051Plak-VacTRADEMARK MEDICAL, L.L.C.NXZ2024-07-18
B23930900Plak-VacTRADEMARK MEDICAL, L.L.C.NXZ2024-07-02
B23931040Plak-VacTRADEMARK MEDICAL, L.L.C.NXZ2024-07-02
B23930901Plak-VacTRADEMARK MEDICAL, L.L.C.NXZ2024-07-02
B23931041Plak-VacTRADEMARK MEDICAL, L.L.C.NXZ2024-07-02
B23931030Plak-VacTRADEMARK MEDICAL, L.L.C.NXZ2024-06-21
B23931031Plak-VacTRADEMARK MEDICAL, L.L.C.NXZ2024-06-21
B23930730Plak-VacTRADEMARK MEDICAL, L.L.C.NXZ2024-04-17
B23930940Plak-VacTRADEMARK MEDICAL, L.L.C.NXZ2024-04-17
B23930950Plak-VacTRADEMARK MEDICAL, L.L.C.NXZ2024-04-17
B23930731Plak-VacTRADEMARK MEDICAL, L.L.C.NXZ2024-04-17
B23930941Plak-VacTRADEMARK MEDICAL, L.L.C.NXZ2024-04-17
B23930951Plak-VacTRADEMARK MEDICAL, L.L.C.NXZ2024-04-17
B23930880Plak-VacTRADEMARK MEDICAL, L.L.C.NXZ2024-02-20