FDA.reportPublic FDA data

Angel Aligner

Primary DI
06956748704417
Brand
Angel Aligner
Company
Wuxi EA Medical Instruments Technologies Limited.
Model
EAB II
Published
2026-05-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
QJJIndirect Bonding Tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QJJIndirect Bonding TrayDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06956748704417PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06956748704417069567487044176956748704417

GMDN Terms#

Term, Definition table
TermDefinition
Orthodontic resin positioning trayA custom-made dental device in the form of a patient’s dentition which contains cavities intended to hold and facilitate positioning of light-cured dental resin onto teeth for subsequent attachment of an orthodontic appliance (e.g. aligner) after curing. It is typically made of synthetic polymer materials and is manufactured from an orthodontic treatment plan based on an oral cavity impression or oral scan for a specific patient. This is a single-use device.

Regulatory Flags#

DUNS number
421315681
Device count
1
Premarket exempt
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
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
06956748709443Angel 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
10850061082029Custom Orthodontic SolutionKlowen Braces, Inc.QJJ2026-05-26
D9821716150LuxaPrint Ortho Flex NXDMG Digital Enterprises SEQJJ2026-05-06
D9821716160LuxaPrint Ortho Flex NXDMG Digital Enterprises SEQJJ2026-05-06
D9821716170LuxaPrint Ortho Flex NXDMG Digital Enterprises SEQJJ2026-05-06
D9821716180LuxaPrint Ortho Flex NXDMG Digital Enterprises SEQJJ2026-05-06
D9821716190LuxaPrint Ortho Flex NXDMG Digital Enterprises SEQJJ2026-05-06
00850070544832IDB 3 Sprintray, Inc.QJJ2026-03-17
00860012928408CelebraceCelebrace Inc.QJJ2025-03-28
00850061082015Custom Digital OrthodonticsKlowen Braces, Inc.QJJ2024-11-21
09359215000055DentaIBTASIGA PTY LTDQJJ2024-02-06
D865REF06001ClearCorrect System Engager TemplateClearcorrect Operating, LLCQJJ2024-02-02
07290018915028MED610STRATASYS LTDQJJ2024-01-10
07290018915219MED610STRATASYS LTDQJJ2024-01-10
07290018915417MED610STRATASYS LTDQJJ2024-01-10
07290018915615MED610STRATASYS LTDQJJ2024-01-10
07290018915813MED610STRATASYS LTDQJJ2024-01-10
D865REF02001ClearCorrect SystemClearcorrect Operating, LLCQJJ2023-08-25
D82854001600Indirect BondFIVE STAR ORTHODONTIC LABORATORY & SUPPLY INCQJJ2022-12-12
D82854001610Indirect Bond W/Hard ShellFIVE STAR ORTHODONTIC LABORATORY & SUPPLY INCQJJ2022-12-12
D82854001660Indirect Bond-EZ_HardSoftFIVE STAR ORTHODONTIC LABORATORY & SUPPLY INCQJJ2022-12-12
D8285401650Digital Indirect BondFIVE STAR ORTHODONTIC LABORATORY & SUPPLY INCQJJ2022-12-12
D918DOCWT0Digital Orthodontic CareDigital Orthodontic CareQJJ2022-12-09
H66842000081KeyPrintKeystone IndustriesQJJ2022-11-30
H66842200081KeyPrintKeystone IndustriesQJJ2022-11-30
D9821712500LuxaPrint Ortho Flex 385DMG Digital Enterprises SEQJJ2022-09-01
D9821712510LuxaPrint Ortho Flex 385DMG Digital Enterprises SEQJJ2022-09-01
D9821712520LuxaPrint Ortho Flex 385DMG Digital Enterprises SEQJJ2022-09-01
D9821712530LuxaPrint Ortho Flex 385DMG Digital Enterprises SEQJJ2022-09-01
D9821712730LuxaPrint Ortho Flex 385DMG Digital Enterprises SEQJJ2022-09-01
D9821712750LuxaPrint Ortho Flex 385DMG Digital Enterprises SEQJJ2022-09-01