FDA.reportPublic FDA data

uLab Systems Dental Aligner

Primary DI
00860002380063
Brand
uLab Systems Dental Aligner
Company
Ulab Systems, Inc.
Model
FG0094 Rev. D
Published
2020-10-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
K192596000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K192596000ULab Systems Dental Aligner KitUlab Systems, Inc.2020-02-11NXC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860002380063PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860002380063008600023800638600023800630860002380063

GMDN Terms#

Term, Definition table
TermDefinition
Dental CAD/CAM system, laboratoryAn assembly of software-based devices designed for automated computer-aided design (CAD) and computer-aided manufacturing (CAM) of custom-made (prescribed for one patient) dental restorations and/or orthodontic appliances (archwires) produced in the dental laboratory. It typically includes three-dimensional (3-D) image acquisition capabilities that provide values (measurements) from, e.g., casts, models or chairside in vivo acquisition to acquire the prescription values for the production phase, software for record collection, treatment planning, simulation and device production, and robotic capabilities for production of the actual device(s) for delivery for final fitting to the patient.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
081092722
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860461001790Reva Thermoforming Sheet MaterialFG00102025-04-29
00860461001714Clearjoy Dental Aligner1FG0094-052023-11-02
00860461001776uLab Systems uDesign10FG00642025-01-28
00860461001783uLab Systems uDesign9FG00642024-05-20
00860002380094uLab Systems Dental AlignerFG0094 2022-06-01
00860461001769uLab Systems uDesign8FG00642023-11-02
00860002380087uLab Systems uDesign72022-04-11
00860002380049uLab Systems uDesign5.9FG00642020-11-16
00860002380070uLab Systems uDesign6.02021-05-10
00860002380032uLab Systems uDesignVersion 5.8FG00642020-07-14
00860002380056uLab Systems Dental AlignerFG00942020-07-20
00860002380025uLab Systems uDesignVersion 5.6FG00642020-07-10
00860002380001uLab Systems uDesignVersion 5FG00642019-09-18
00860002380018uLab Systems uDesignVersion 5.5FG00642020-02-18
00860461001707uLab Systems uDesignVersion 2.2FG00642018-08-20
00000860002381uLab Systems uDesignVersion 5.5FG00642020-02-18
00008600023801uLab Systems uDesignVersion 5FG00642019-09-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850004223307CandidProCANDID CARE CO.NXC2026-09-04
00850004223413CandidProCANDID CARE CO.NXC2026-09-04
08800142100963TERA HARZ CLEARGraphy Inc.NXC2026-08-21
08800142100987TERA HARZ CLEARGraphy Inc.NXC2026-08-21
08800142100994TERA HARZ CLEARGraphy Inc.NXC2026-08-21
00850004223253CandidProCANDID CARE CO.NXC2026-07-27
00850004223260CandidProCANDID CARE CO.NXC2026-07-27
00850004223314ProMonitoringCANDID CARE CO.NXC2026-07-27
00850004223352ProMonitoringCANDID CARE CO.NXC2026-07-27
00850004223383OlivCANDID CARE CO.NXC2026-07-27
00850004223390OlivCANDID CARE CO.NXC2026-07-27
00850004223550CandidProCANDID CARE CO.NXC2026-07-27
00856379007313SureSmile®ORAMETRIX, INC.NXC2026-05-20
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