FDA.reportPublic FDA data

Digital Orthodontic Care

Primary DI
D918DOCWT0
Brand
Digital Orthodontic Care
Company
Digital Orthodontic Care
Model
DOCWT
Published
2022-12-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
D918DOCWT0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Orthodontic appliance positioning trayA custom-made dental device in the form of a patient’s dentition with slots/sockets intended to position and hold in place a set of orthodontic appliances (e.g., brackets, buccal tubes, lingual retainers) [not included] to bond them to teeth during a single procedure; the orthodontic appliances are loaded onto the device by the orthodontist prior to the procedure. Also known as an indirect bonding tray, it is typically made of synthetic polymer materials and is manufactured from an oral cavity impression or oral scan for a specific patient. This is a single-use device.

Regulatory Flags#

DUNS number
203697156
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D918SCA0SureCureAligners2019-07-08
D918SCA2SureCureAligners2019-07-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10850061082029Custom Orthodontic SolutionKlowen Braces, Inc.QJJ2026-05-26
06956748704417Angel AlignerWuxi EA Medical Instruments Technologies Limited.QJJ2026-05-19
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
00816063022169Attachment TemplateAlign Technology, Inc.QJJ2023-07-24
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
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