FDA.report

Taglus Premium

Primary DI
28906139321473
Brand
Taglus Premium
Company
LAXMI DENTAL LIMITED
Model
VS021
Device description
Thickness: 1.02 mm, Size: 125 mm, Shape: Round
Published
2026-01-09
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
true

Related Records

Product Codes

CodeName
KMYPositioner, Tooth, Preformed

Product Code Classifications

CodeDeviceSpecialtyClass
KMYPositioner, Tooth, PreformedDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08906139321479PrimaryGS10
28906139321473Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08906139321479089061393214798906139321479
2890613932147328906139321473

GMDN Terms

TermDefinition
Dental appliance fabrication material, thermoplasticA thermoplastic material intended to be used in the dental laboratory to manufacture a patient-worn dental appliance (e.g., denture/denture base, orthodontic retainer, implant bars, crowns/bridges, occlusal splint, mouthguard); it might in addition be intended to fabricate non-patient worn devices (e.g., dental impression tray). The material [e.g., nylon 12 beads, polyetheretherketone (PEEK) milling blank, thermoplastic sheet] is manipulated [e.g., by melting and moulding, or computer-aided techniques (dental CAD/CAM)] to form the shape needed for the patient. After application, this material cannot be refabricated.

Sterilization Methods

Method

Regulatory Flags

DUNS number
644980314
Device count
100
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
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 DIBrandModelCatalogPublished
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08906139320694Taglus Model Resin SVS3282026-01-09
28906139321169Taglus UltraVS8122026-01-09
28906139321466Taglus PremiumVS0192026-01-09
28906139321480Taglus PremiumVS0222026-01-09
28906139321497Taglus PremiumVS0232026-01-09
28906139321527Taglus PremiumVS0282026-01-09
28906139321695Taglus StandardVS2382026-01-09
28906139321718Taglus StandardVS2402026-01-09
28906139321749Taglus StandardVS2422026-01-09
28906139321756Taglus StandardVS2442026-01-09
28906139321824Taglus PU FlexVS2792026-01-09
28906139321831Taglus PU FlexVS2802026-01-09
28906139321855Taglus PU FlexVS2842026-01-09
28906139321879Taglus PU FlexVS2822026-01-09
28906139321923Taglus TuffVS0962026-01-09
28906139321947Taglus TuffVS0982026-01-09
28906139321954Taglus TuffVS0992026-01-09
28906139322081Taglus Impression TrayVS10922026-01-09
28906139322098Taglus Ortho ChewiesVS5392026-01-09

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
07908611205742TERMOPLASTIC PLAQUE FOR ALIGNERS PRO ALIGNER X – 125x125x0.76MM - 25UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAKMY2026-05-26
07908611205759TERMOPLASTIC PLAQUE FOR ALIGNERS PRO ALIGNER X – 125x125x1MM - 10UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAKMY2026-05-26
00815967029380RodinPac-Dent, Inc.KMY2026-03-23
00815967029397RodinPac-Dent, Inc.KMY2026-03-23
06974361422556Zhejiang YinchiliZhejiang Yinchili Medical Technology Co., Ltd.KMY2026-03-23
06974361422563Zhejiang YinchiliZhejiang Yinchili Medical Technology Co., Ltd.KMY2026-03-23
06974361422570Zhejiang YinchiliZhejiang Yinchili Medical Technology Co., Ltd.KMY2026-03-23
06974361422587Zhejiang YinchiliZhejiang Yinchili Medical Technology Co., Ltd.KMY2026-03-23
06974361423058Zhejiang YinchiliZhejiang Yinchili Medical Technology Co., Ltd.KMY2026-03-23
06974361423065Zhejiang YinchiliZhejiang Yinchili Medical Technology Co., Ltd.KMY2026-03-23
06974361423072Zhejiang YinchiliZhejiang Yinchili Medical Technology Co., Ltd.KMY2026-03-23
06974361423089Zhejiang YinchiliZhejiang Yinchili Medical Technology Co., Ltd.KMY2026-03-23
03770020010163FroggymouthBIOTECH DENTAL SMILERSKMY2026-03-17
03770020010170FroggymouthBIOTECH DENTAL SMILERSKMY2026-03-17
03770020010187FroggymouthBIOTECH DENTAL SMILERSKMY2026-03-17
D775JAGFP0AccuguardGreat Lakes Dental Technologies, Ltd.KMY2026-01-16
28906139321169Taglus UltraLAXMI DENTAL LIMITEDKMY2026-01-09
28906139321466Taglus PremiumLAXMI DENTAL LIMITEDKMY2026-01-09
28906139321480Taglus PremiumLAXMI DENTAL LIMITEDKMY2026-01-09
28906139321497Taglus PremiumLAXMI DENTAL LIMITEDKMY2026-01-09
28906139321527Taglus PremiumLAXMI DENTAL LIMITEDKMY2026-01-09
28906139321695Taglus StandardLAXMI DENTAL LIMITEDKMY2026-01-09
28906139321718Taglus StandardLAXMI DENTAL LIMITEDKMY2026-01-09
28906139321749Taglus StandardLAXMI DENTAL LIMITEDKMY2026-01-09
28906139321756Taglus StandardLAXMI DENTAL LIMITEDKMY2026-01-09
28906139321824Taglus PU FlexLAXMI DENTAL LIMITEDKMY2026-01-09
28906139321831Taglus PU FlexLAXMI DENTAL LIMITEDKMY2026-01-09
28906139321855Taglus PU FlexLAXMI DENTAL LIMITEDKMY2026-01-09
28906139321879Taglus PU FlexLAXMI DENTAL LIMITEDKMY2026-01-09
28906139321923Taglus TuffLAXMI DENTAL LIMITEDKMY2026-01-09