FDA.reportPublic FDA data

VIVID Aligners

Primary DI
00860011027201
Brand
VIVID Aligners
Company
Ortho Dent Laboratory Inc
Model
7201
Device description
Sequential aligner
Published
2023-12-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
K190003000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K190003000Vivid AlignersOrthodent Laboratory, Inc.2019-11-06NXC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860011027201PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860011027201008600110272018600110272010860011027201

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

Regulatory Flags#

DUNS number
623178647
Device count
1

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00816063022305Invisalign System with Integrated ButtonsAlign Technology, Inc.NXC2026-09-29
00816063023418Invisalign Palatal Expander with Engagement FeaturesAlign Technology, Inc.NXC2026-09-29
00816063023425Invisalign Palatal Holder with Engagement FeaturesAlign Technology, Inc.NXC2026-09-29
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
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