FDA.reportPublic FDA data

ORTHOMETRIC PRO ALIGNER X

Primary DI
07898488900614
Brand
ORTHOMETRIC PRO ALIGNER X
Company
ORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDA
Model
30.11.0053
Catalog number
30.11.0053
Device description
ALIGNER SHEETS- PRO ALIGNER X- Ø 125 X 0,76 MM- PCT 25 UN
Published
2022-09-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
07898488900614PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07898488900614078984889006147898488900614

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
898330003
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07898488900621KIT THERMO 35° WIRES - ROUNDS + RECTANGULARS - 100 TENS51.35.28012026-05-27
07898488905107WEINGART PLIER W/OUT WIDIA75.01.01212026-05-27
07898488905190INSTRUMENT FOR ICERAM SLB BRACKET75.00.00012026-05-27
07898488907217TUBE CONVERSION PLIER – 400375.01.05152026-05-27
07898488909945ELASTIC LIGATURE APPLICATOR/REMOVER75.00.00042026-05-27
07908470705735PLIER ANGLE W/ WIDIA AND CUTTING (139)75.01.11552026-05-27
07908470705803TORQUE PLIER SHORT (442)75.01.00232026-05-27
07908470707135ORTHODONTIC ELASTIC INTRAORAL - LATEX HEAVY 1/4 - SILMET60.01.20082026-05-27
07908470707142ORTHODONTIC ELASTIC INTRAORAL - LATEX HEAVY 3/16 - SILMET60.01.20072026-05-27
07908470707159ORTHODONTIC ELASTIC INTRAORAL - LATEX MEDIUM 1/4 - SILMET60.01.10082026-05-27
07908470707166ORTHODONTIC ELASTIC INTRAORAL - LATEX MEDIUM 3/16 - SILMET60.01.10072026-05-27
07908611200129PLIER FOR LONG TORQUE (442)75.01.08062026-05-27
07908611200822TUNGSTEN CARBIDE CUTTING BUR CC136FX LOW SPEED - 1UN75.80.10062026-05-27
07908611204325ANGULAR BRACKET REMOVAL PLIER75.01.00042026-05-27
07908611205964ORTHOMETRIC ELASTIC STICK LIGATURE - ORANGE60.03.10562026-05-27
07908611207944KIT ELASTOMERIC - STICK LIGATURES - 23 COLORS60.03.29102026-05-27
07908611207951KIT ELASTOMERIC - ELASTIC CHAIN 1,5M - MEDIUM - 23 COLORS60.05.29102026-05-27
07908611207968KIT ELASTOMERIC - MODULAR LIGATURE 22 TIES - 10 COLORS60.06.29102026-05-27
07908611210654ORTHOMETRIC ELASTIC CHAIN 1.5M - LONG - CARIBBEAN BLUE60.05.70592026-05-27
07908611210715ORTHOMETRIC ELASTIC STICK LIGATURE - CORAL60.03.10572026-05-27

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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
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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
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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