FDA.reportPublic FDA data

Clearguide Express

Primary DI
00889989061987
Brand
Clearguide Express
Company
ALLESEE AOA-PRO
Model
3000-0006
Device description
Set of clear plastic aligners – corrects minor to intermediate anterior malalignments of teeth
Published
2016-09-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
K093821000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K093821000FS ALIGNERAllesee Orthodontic Appliances2010-08-27NXC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00889989061987PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889989061987008899890619878899890619870889989061987

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

Contacts#

Phone, Email table
PhoneEmail
262-886-1050xxx@xxx.xxx

Regulatory Flags#

DUNS number
158312728
Device count
1
Kit
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00889989087864AOB Splint3000-01282023-04-05
00889989087871Bruxism Splint3000-01272023-04-05
00889989087888Damon Retention Splint3000-01262023-04-05
00889989087895Bite Orthotic Appliance3000-01252023-04-05
00889989087901Intrusion Splint3000-01242023-04-05
00889989087918Mora-Gelb Splint3000-01222023-04-05
00889989087925Flat Plane Splint3000-01212023-04-05
00889989088021Flexiclear3000-00612023-04-05
00889989074468Repositioning Splint3000-01232023-03-13
00889989088571Prezurv Plus3000-01382024-05-03
00889989081817Memotain3000-01352023-07-24
00889989087642Archwire Extender Accessory, Size .022, Cast Body, Pk of 101604-33222023-04-05
00889989087673Herbst Pistons, Pk/2MATER012023-04-05
00889989087680Herbst Sleeves, setMATER022023-04-05
008899890876975.5mm Hex Screw, Pk/10MATER05A2023-04-05
008899890877031mm Round Spacer, Pk/10MATER072023-04-05
008899890877102mm Round Spacer, Pk/10MATER082023-04-05
008899890877273mm Round Spacer, Pk/10MATER092023-04-05
008899890877344mm Round Spacer, Pk/10MATER102023-04-05
00889989087741AppleCore Screw, Pk/10MATER1002023-04-05

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