FDA.reportPublic FDA data

Invisible Orthodontic Appliance

Primary DI
06970402670504
Brand
Invisible Orthodontic Appliance
Company
SHANDONG HUGE DENTAL MATERIAL CORPORATION
Model
LX-A
Published
2019-07-12
Public version status
Update
Distribution status
Not 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
K181747000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K181747000Orthodontic ApplianceShandong Huge Dental Material Corporation2019-04-18NXC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06970402670504PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06970402670504069704026705046970402670504

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
528184691
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06909412319455Dental ModelM 2.01.0 kg/bottle2026-05-19
06909412319929Porcelain PowdersPowderA/10g2026-05-19
06909412319936Porcelain PowdersPowderB/10g2026-05-19
06909412320024Porcelain PowdersBlending LiquidL1/20mL2026-05-19
06909412320031Porcelain PowdersBlending LiquidL2/20mL2026-05-19
06909412320048Porcelain PowdersStain/GlazeA/5g2026-05-19
06909412320055Porcelain PowdersStain/GlazeB/5g2026-05-19
06909412320246Porcelain Powders/K-001-162026-05-19
06909412327825Dental ModelM 3.01.0 kg/bottle2026-05-19
06909412327900Denture BaseDB2S/500 g/bottle2026-05-19
06909412327917Denture BaseDB2S/1.0 kg/bottle2026-05-19
06909412327924Denture BaseDBPink/500 g/bottle2026-05-19
06909412327931Denture BaseDBPink/1.0 kg/bottle2026-05-19
06909412327948Denture BaseDBPink1/500 g/bottle2026-05-19
06909412327955Denture BaseDBPink1/1.0 kg/bottle2026-05-19
06909412327962Denture BaseDBPink2/500 g/bottle2026-05-19
06909412327979Denture BaseDBPink2/1.0 kg/bottle2026-05-19
06909412327986Denture BaseDBPink3/500 g/bottle2026-05-19
06909412327993Denture BaseDBPink3/1.0 kg/bottle2026-05-19
06909412328006Denture BaseDBPink4/500 g/bottle2026-05-19

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