FDA.report

LMDental

Primary DI
06438311221908
Brand
LMDental
Company
LM-Dental
Model
9402
Device description
LM-Activator 2 OrthoSizer
Published
2020-08-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
KMYPositioner, Tooth, Preformed

Product Code Classifications

CodeDeviceSpecialtyClass
KMYPositioner, Tooth, PreformedDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
06438311221908PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
06438311221908064383112219086438311221908

GMDN Terms

TermDefinition
Orthodontic retainerA dental orthodontic appliance, fixed or removable, used to maintain teeth in corrected positions during the period of functional adaptation following corrective treatment. This appliance is also used to maintain the positions of the teeth and jaws gained by orthodontic procedures. This is a single-patient device that is used for the duration of the treatment (single-use) before being discarded.

Sterilization Methods

Method

Regulatory Flags

DUNS number
401969969
Device count
1
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
false
Expiration date on label
false
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
06438311708676LMDental444-445XSIGC2026-03-23
06438311708683LMDental473-753XSIGC2026-03-23
06438311708690LMDental473-753XSI2026-03-23
06438311708706LMDental473-753ES2026-03-23
06438311708713LMDental473-753EST2026-03-23
06438311708720LMDental473-753ESTU2026-03-23
06438311708737LMDental743-753XSI2026-03-23
06438311708744LMDental743-753ES2026-03-23
06438311708751LMDental743-753EST2026-03-23
06438311708768LMDental743-753ESTU2026-03-23
06438311207407LMDental211-212AFES2025-12-31
06438311208251LMDental213-214AFES2025-12-31
06438311707303LMDental132-133XSI2025-03-06
06438311707310LMDental132-133ES2025-03-06
06438311707327LMDental132-133EST2025-03-06
06438311707334LMDental132-133ESTU2025-03-06
06438311707341LMDental335-340DDES2025-03-06
06438311707358LMDental335-340DDEST2025-03-06
06438311707365LMDental335-340DDESTU2025-03-06
06438311707372LMDental352-353DDES2025-03-06

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
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
28906139321473Taglus 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
28906139321947Taglus TuffLAXMI DENTAL LIMITEDKMY2026-01-09