FDA.reportPublic FDA data

angel aligner

Primary DI
06956748701270
Brand
angel aligner
Company
Wuxi EA Medical Instruments Technologies Limited.
Model
EAB II
Published
2023-06-25
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
K223517000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K223517000Clear AlignerWuxi EA Medical Instruments Technologies Limited.2023-06-13NXC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06956748701270PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06956748701270069567487012706956748701270

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
421315681
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06956748702642Angel AlignerEAB II2026-10-10
06956748702659Angel AlignerRetainer2026-10-10
06956748700761Angel AlignerRetainer2026-02-04
06956748701621IMPRESSRetainer2026-02-04
06956748701669ProgressiveRetainer2026-02-04
06956748702000OrthoArchRetainer2026-02-04
06956748702062Angel AlignerRetainer2026-02-04
06956748702406SimplyClearRetainer2026-02-04
06956748709436Angel AlignerRetainer2026-02-04
06956748704417Angel AlignerEAB II2026-05-19
06956748704394LUMOSCOEAB II2026-05-12
06956748704400LUMOSCORetainer2026-05-12
06956748700198Angel AlignerEAB II2026-05-06
06956748701997OrthoArchEAB II2026-02-04
06956748702055Angel AlignerEAB II2026-02-04
06956748702147Angel AlignerEAB II2026-02-04
06956748702390SimplyClearEAB II2026-02-04
06956748709429Angel AlignerEAB II2026-02-04
06956748709443Angel AlignerEAB II2026-02-04
06956748701614IMPRESSEAB II2023-12-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06956748702642Angel AlignerWuxi EA Medical Instruments Technologies Limited.NXC2026-10-10
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