FDA.reportPublic FDA data

MyoSimple

Primary DI
03770020010248
Brand
MyoSimple
Company
BIOTECH DENTAL SMILERS
Model
MyoSimple Standard Size
Catalog number
MYOSIMPLE
Published
2026-03-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
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
03770020010248PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03770020010248037700200102483770020010248

GMDN Terms#

Term, Definition table
TermDefinition
Orthodontic retainerAn orthodontic appliance, bonded or removable, intended to be used on a single patient to maintain teeth in corrected positions during the period of functional adaptation following corrective treatment. This appliance, also referred to as a positioner, is also used to maintain the positions of the teeth and jaws gained by orthodontic procedures.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Height41.5Millimeter
Length62.94Millimeter
Width22.2Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep away from heat, sunlight, and sources of radiation.
Storage Environment Temperature5 Degrees Celsius40 Degrees Celsius

Regulatory Flags#

DUNS number
266048588
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03770020010255MyoSimpleMyoSimple Small Size2026-03-26
03770020010163FroggymouthFroggymouth size SFM2017-012026-03-17
03770020010170FroggymouthFroggymouth size M2026-03-17
03770020010187FroggymouthFroggymouth size L2026-03-17
03770020010057SmilersRetainer ApplianceGOUTC2022-04-20
03770020010019SmilersAlignerALIGNEURS2022-04-20
03770020010033SmilersAttachement placement alignerGOUTP2022-04-20
03770020010064SmilersRetainer ApplianceGOUTC2022-04-20
03770020010088SmilersReproduction AlignerALIGN_REPRO2022-04-20
03770020010002SmilersAlignerALIGNEURS2022-04-20
03770020010026SmilersAttachement placement alignerGOUTP2022-04-20
03770020010040SmilersPassive ApplianceGOUTPA2022-04-20
03770020010071SmilersReproduction AlignerALIGN_REPRO2022-04-20

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