FDA.reportPublic FDA data

Smilers

Primary DI
03770020010019
Brand
Smilers
Company
BIOTECH DENTAL SMILERS
Model
Aligner
Catalog number
ALIGNEURS
Device description
aligners for 2 archs
Published
2022-04-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true

Product Codes#

Code, Name table
CodeName
NXCAligner, Sequential

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NXCAligner, SequentialDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K212961000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K212961000SMILERSBiotech Dental Smilers, Sas2021-09-20NXC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03770020010019PrimaryGS10
03770020010002Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03770020010019037700200100193770020010019
03770020010002037700200100023770020010002

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
266048588
Device count
2
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03770020010248MyoSimpleMyoSimple Standard SizeMYOSIMPLE2026-03-26
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
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
00856379007313SureSmile®ORAMETRIX, INC.NXC2026-05-20
06956748704394LUMOSCOWuxi EA Medical Instruments Technologies Limited.NXC2026-05-12
D77595102Smart Moves Complete Phase 1 TraysGreat Lakes Dental Technologies, Ltd.NXC2026-05-07
D775AASS0Super Spring AlignerGreat Lakes Dental Technologies, Ltd.NXC2026-05-07
D775ABLR0Bloore Removable AlignerGreat Lakes Dental Technologies, Ltd.NXC2026-05-07
D775AII0Invisible Inman AlignerGreat Lakes Dental Technologies, Ltd.NXC2026-05-07
D775ALIA0Lower Inman AlignerGreat Lakes Dental Technologies, Ltd.NXC2026-05-07
D775ALIAW0Lower Inman Aligner 'Wireless' Great Lakes Dental Technologies, Ltd.NXC2026-05-07
06956748700198Angel AlignerWuxi EA Medical Instruments Technologies Limited.NXC2026-05-06
00197998216398Clarity™Solventum Orthodontics CorporationNXC2026-04-25
00197998216428Clarity™Solventum Orthodontics CorporationNXC2026-04-25
00197998216435Clarity™Solventum Orthodontics CorporationNXC2026-04-25
00197998216480Clarity™Solventum Orthodontics CorporationNXC2026-04-25
00197998216527Clarity™Solventum Orthodontics CorporationNXC2026-04-25
00197998216534Clarity™Solventum Orthodontics CorporationNXC2026-04-25
00197998216572Clarity™Solventum Orthodontics CorporationNXC2026-04-25
00197998216596Clarity™Solventum Orthodontics CorporationNXC2026-04-25
00197998216657Clarity™Solventum Orthodontics CorporationNXC2026-04-25
00197998216664Clarity™Solventum Orthodontics CorporationNXC2026-04-25
00197998216671Clarity™Solventum Orthodontics CorporationNXC2026-04-25
00197998382772Clarity™Solventum Orthodontics CorporationNXC2026-04-25
00197998382796Clarity™Solventum Orthodontics CorporationNXC2026-04-25
00860015708106SunClear AlignersSun Dental Laboratories, LLCNXC2026-04-16
00860015708113CoastClear AlignersSun Dental Laboratories, LLCNXC2026-04-16
D769CMALIGN0Clear MovesPARK DENTAL RESEARCH CORPNXC2026-04-15
D769CMRETAIN0Clear MovesPARK DENTAL RESEARCH CORPNXC2026-04-15
D769WLALIGN0White LabelPARK DENTAL RESEARCH CORPNXC2026-04-15
D769WLRETAIN0White LabelPARK DENTAL RESEARCH CORPNXC2026-04-15
D769ORCALIGN0Orchestrate 3DPARK DENTAL RESEARCH CORPNXC2026-04-14
D769ORCRETAIN0Orchestrate 3DPARK DENTAL RESEARCH CORPNXC2026-04-14