FDA.reportPublic FDA data

Taglus Ortho Chewies

Primary DI
08906139322094
Brand
Taglus Ortho Chewies
Company
LAXMI DENTAL LIMITED
Model
VS539
Published
2026-01-09
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
KMYPositioner, Tooth, Preformed

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KMYPositioner, Tooth, PreformedDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08906139322094PrimaryGS10
28906139322098Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08906139322094089061393220948906139322094
2890613932209828906139322098

GMDN Terms#

Term, Definition table
TermDefinition
Orthodontic aligner/retainer seater, single-useA small cylindrical pledget intended to be used to facilitate placement and proper seating of an orthodontic progressive aligner or teeth retainer (positioner), by being placed between the partially-aligned aligner/retainer and the opposing set of teeth, allowing the patient to bite down on the device to push the aligner/retainer into place. This is a single-use device.

Regulatory Flags#

DUNS number
644980314
Device count
2
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
08906139321165Taglus UltraVS8122026-01-09
08906139321462Taglus PremiumVS0192026-01-09
08906139321479Taglus PremiumVS0212026-01-09
08906139321486Taglus PremiumVS0222026-01-09
08906139321493Taglus PremiumVS0232026-01-09
08906139321523Taglus PremiumVS0282026-01-09
08906139321691Taglus StandardVS2382026-01-09
08906139321714Taglus StandardVS2402026-01-09
08906139321745Taglus StandardVS2422026-01-09
08906139321752Taglus StandardVS2442026-01-09
08906139321820Taglus PU FlexVS2792026-01-09
08906139321837Taglus PU FlexVS2802026-01-09
08906139321851Taglus PU FlexVS2842026-01-09
08906139321875Taglus PU FlexVS2822026-01-09
08906139321929Taglus TuffVS0962026-01-09
08906139321943Taglus TuffVS0982026-01-09
08906139321950Taglus TuffVS0992026-01-09
08906139322087Taglus Impression TrayVS10922026-01-09
08906139320670Taglus Model ResinVS0662026-01-09
08906139320694Taglus Model Resin SVS3282026-01-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800142101007Tera TainerGraphy Inc.KMY2026-05-14
H66842000141KeyPrintKeystone IndustriesKMY2024-09-26
H66841101411KeyPrintKeystone IndustriesKMY2023-09-25
H66842201511KeyPrintKeystone IndustriesKMY2023-09-25
08719425509549Vertex-Dental BVVertex-Dental B.V.KMY2023-06-20
08719425509556NextDentVertex-Dental B.V.KMY2023-06-15
H66842000111KeyPrintKeystone IndustriesKMY2023-02-20
H66842001611KeyPrintKeystone IndustriesKMY2023-02-20
H66842200111KeyPrintKeystone IndustriesKMY2023-02-20
H66842201141HeyGearsKeystone IndustriesKMY2023-02-20
EPRCD1001609PRO3DURE GR-19 OApro3dure medical GmbHKMY2022-12-06
EPRCD1001610PRO3DURE GR-19 OApro3dure medical GmbHKMY2022-12-06
EPRCD1001611PRO3DURE GR-19 OApro3dure medical GmbHKMY2022-12-06
H668210241American DentalKeystone IndustriesKMY2022-11-30
H668210251American DentalKeystone IndustriesKMY2022-11-30
H668210261American DentalKeystone IndustriesKMY2022-11-30
H668210271American DentalKeystone IndustriesKMY2022-11-30
H668210341American DentalKeystone IndustriesKMY2022-11-30
EPRCD1001703PRO3DURE GR-22 flex pro3dure medical GmbHKMY2022-02-14
EPRCD1001704PRO3DURE GR-22 flex pro3dure medical GmbHKMY2022-02-14
EPRC66077916dima Print Splint clear pro3dure medical GmbHKMY2021-11-25
EPRCD1000800PRO3DURE GR-10 guidepro3dure medical GmbHKMY2021-10-29
EPRCD1000801PRO3DURE GR-10 guidepro3dure medical GmbHKMY2021-10-29
EPRCD1001491PRO3DURE GR-19 OApro3dure medical GmbHKMY2021-10-29
EPRCD1001492PRO3DURE GR-19 OApro3dure medical GmbHKMY2021-10-29
EPRCD1001493PRO3DURE GR-19 OApro3dure medical GmbHKMY2021-10-29
EPRCD1001701PRO3DURE GR-22 flex pro3dure medical GmbHKMY2021-10-29
EPRCD1001702PRO3DURE GR-22 flex pro3dure medical GmbHKMY2021-10-29
ERKO5142052ErkolenErkodent Erich Kopp GmbHKMY2021-09-21
ERKO5142072ErkolenErkodent Erich Kopp GmbHKMY2021-09-21