FDA.reportPublic FDA data

TERMOPLASTIC PLAQUE FOR ALIGNERS PRO ALIGNER X – 125x125x1MM - 10UN

Primary DI
07908611205759
Brand
TERMOPLASTIC PLAQUE FOR ALIGNERS PRO ALIGNER X – 125x125x1MM - 10UN
Company
ORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDA
Model
30.12.0066
Device description
TERMOPLASTIC PLAQUE FOR ALIGNERS PRO ALIGNER X – 125x125x1MM - 10UN
Published
2026-05-26
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
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
07908611205759PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07908611205759079086112057597908611205759

GMDN Terms#

Term, Definition table
TermDefinition
Orthodontic progressive alignerA custom-made orthodontic appliance, typically supplied in series intended to be worn in succession and self-changed every few weeks, designed to influence the shape and/or function of the stomatognathic system to correct malocclusions (e.g., underbites, overbites, cross bites, open bites, crooked teeth) and/or other cosmetic and/or structural flaws of teeth and/or jaws. Also described as sequential or successive, the device is custom-made based on an oral impression, self-removable, and is typically made of clear/transparent synthetic polymers (e.g., a thermoformed polycarbonate); a post-treatment orthodontic retainer/positioner may be included with the device. This is a reusable device.

Regulatory Flags#

DUNS number
898330003
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07898488904056METAL BRACKET ADVANCED ROTH 0.022 - U1R (11) - 100UN10.10.23112026-05-26
07898488904063METAL BRACKET ADVANCED ROTH 0.022 - U2R (12) - 100UN10.10.23122026-05-26
07898488904070METAL BRACKET ADVANCED ROTH 0.022 - U3R (13) - 100UN10.10.23132026-05-26
07898488904087METAL BRACKET ADVANCED ROTH 0.022 - U45R (14,15) - 100UN10.10.23142026-05-26
07898488904094METAL BRACKET ADVANCED ROTH 0.022 - U1L (21) - 100UN10.10.23212026-05-26
07898488904100METAL BRACKET ADVANCED ROTH 0.022 - U2L (22) - 100UN10.10.23222026-05-26
07898488904117METAL BRACKET ADVANCED ROTH 0.022 - U3L (23) - 100UN10.10.23232026-05-26
07898488904124METAL BRACKET ADVANCED ROTH 0.022 - U45L (24,25) - 100UN10.10.23242026-05-26
07898488904148METAL BRACKET ADVANCED ROTH 0.022 - L3L (33) - 100UN10.10.23332026-05-26
07898488904155METAL BRACKET ADVANCED ROTH 0.022 - L4L (34) - 100UN10.10.23342026-05-26
07898488904162METAL BRACKET ADVANCED ROTH 0.022 - L5L (35) - 100UN10.10.23352026-05-26
07898488904179METAL BRACKET ADVANCED ROTH 0.022 - L3R (43) - 100UN10.10.23432026-05-26
07898488904186METAL BRACKET ADVANCED ROTH 0.022 - L4R (44) - 100UN10.10.23442026-05-26
07898488904193METAL BRACKET ADVANCED ROTH 0.022 - L5R (45) - 100UN10.10.23452026-05-26
07908470701294STAINLESS STEEL - WIRE ROUND 0.014 - UPPER - 12UN51.60.20142026-05-26
07908470701355STAINLESS STEEL - WIRE RECTANGULAR 0.019X0.025 - UPPER - 12UN51.60.25192026-05-26
07908470707678KIT LAUNCH - U-CLIP10.45.23012026-05-26
07908470708798KIT ARCHWIRE SEQUENCE HEAVY51.35.28032026-05-26
07908611202772CERAMIC BRACKET ICERAM MBT 0.022 L5R (45) - 1UN10.84.22452026-05-26
07908611204103CERAMIC MINI TUBE -10UN21.02.20042026-05-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07908611205742TERMOPLASTIC PLAQUE FOR ALIGNERS PRO ALIGNER X – 125x125x0.76MM - 25UNORTHOMETRIC - 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
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