FDA.reportPublic FDA data

EZ-Align

Primary DI
D84100911Z
Brand
EZ-Align
Company
Ortho Solutions, LC
Model
0091
Catalog number
0091
Device description
Clear Sequential Aligner System
Published
2017-02-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
Single use
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
K121396000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K121396000DYNAFLEXDyna Flex2012-08-14NXC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D84100911ZPrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Orthodontic appliance system, progressiveA series of preformed teeth aligners or positioners, worn in succession and changed every few weeks, designed to influence the shape and/or function of the stomatognathic system; often used to impact a patient's appearance and self image. It is typically custom-made using computer-generated modelling based on an initial oral impression, and a consultation with an orthodontist. It is typically made of a clear hard plastic, e.g., a thermoformed polycarbonate (PC). It is typically used to correct malocclusions such as underbites, overbites, cross bites and open bites, or crooked teeth and various other flaws of teeth and jaws, whether cosmetic or structural. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
006335558
Device count
1
DM exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D841300R8151Clearviz Mini300-R8-2026-05-14
D841300R81511Clearviz Mini300-R8-2026-05-14
D841300R8211Clearviz Mini300-R8-2026-05-14
D841300R8221Clearviz Mini300-R8-2026-05-14
D841300R82311Clearviz Mini300-R8-2026-05-14
D841300R8241Clearviz Mini300-R8-2026-05-14
D841300R82411Clearviz Mini300-R8-2026-05-14
D841300R8251Clearviz Mini300-R8-2026-05-14
D841300R82511Clearviz Mini300-R8-2026-05-14
D841300R831Clearviz Mini300-R8-2026-05-14
D841300R8311Clearviz Mini300-R8-2026-05-14
D841300R83311Clearviz Mini300-R8-2026-05-14
D841300R8341Clearviz Mini300-R8-2026-05-14
D841300R83411Clearviz Mini300-R8-2026-05-14
D841300R83451Clearviz Mini300-R8-2026-05-14
D841300R8351Clearviz Mini300-R8-2026-05-14
D841300R83511Clearviz Mini300-R8-2026-05-14
D841300R84311Clearviz Mini300-R8-2026-05-14
D841300R8441Clearviz Mini300-R8-2026-05-14
D841300R84411Clearviz Mini300-R8-2026-05-14

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