FDA.reportPublic FDA data

Candid Aligner

Primary DI
00850004223222
Brand
Candid Aligner
Company
CANDID CARE CO.
Model
FA-0003
Device description
Candid Aligner System FA-0003
Published
2020-08-28
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NXCAligner, Sequential

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NXCAligner, SequentialDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K182329000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K182329000SureCure Orthodontic Aligner SystemDigital Orthodontic Care2018-11-08NXC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850004223222PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850004223222008500042232228500042232220850004223222

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

Contacts#

Phone, Email table
PhoneEmail
917-754-2056dan.michaeli@candidco.com

Regulatory Flags#

DUNS number
108729170
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850004223321PermaForm RetainerFGS-00032025-11-06
00850004223376Oliv AlignerFGS-30022025-11-06
00850004223789Candid Impression KitFGS-00092021-04-26
00850004223079Candid Redo Impression KitRDLGORANGE000012019-03-01
00850004223031Candid Redo Impression KitURBD00032019-03-01
08500042230004Candid AlignerFA-00012020-10-02
00850004223345Candid Impression KitFGS-00102021-10-07
00850004223567Candid AlignerFA-00012021-05-03
00850004223987Candid Refinement Impression KitITISK000012021-03-31
00850004223024Candid Impression KitIKHELLO000012020-07-20
00850004223130Candid Redo Impression KitRDKETTS00012019-10-04
00850004223147Candid Redo Impression KitRDKETTM00012019-10-04
00850004223154Candid Redo Impression KitRDKETTL00012019-10-04
00850004223161Candid Impression KitIKDIGITAL000032019-10-04
00850004223178Candid Impression KitIKMIXFINISHED000012019-10-04
00850004223000Candid Impression KitIKDIGITAL000052020-04-03
00850004223116Candid Impression KitIKMESHFINISHED000022019-10-29
00850004223185Candid Impression KitIKDIGITAL000042019-10-29
00850004223123Candid Impression KitIKDIGITAL000022019-07-09
00850004223109Candid Impression KitIKMESHFINISHED000012019-06-12

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