FDA.reportPublic FDA data

Clear Image Aligner Advanced (Z-FLX): Lower

Primary DI
D8197000870
Brand
Clear Image Aligner Advanced (Z-FLX): Lower
Company
SPECIALTY APPLIANCES, LLC
Model
700087
Device description
Clear Image Aligner Advanced (Z-FLX): Lower
Published
2021-09-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
NXCAligner, Sequential

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NXCAligner, SequentialDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D8197000870PrimaryHIBCC0

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
106645484
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D8199512450G4 NiTi Lingual Wire .010 Small Upper9512452025-07-18
D8199512460G4 NiTi Lingual Wire .010 Small Lower9512462025-07-18
D8199512470G4 NiTi Lingual Wire .010 Medium Upper9512472025-07-18
D8199512480G4 NiTi Lingual Wire .010 Medium Lower9512482025-07-18
D8199512490G4 NiTi Lingual Wire .010 Large Upper9512492025-07-18
D8199512500G4 NiTi Lingual Wire .010 Large Lower9512502025-07-18
D8199512510G4 NiTi Lingual Wire .013 Small Upper9512512025-07-18
D8199512520G4 NiTi Lingual Wire .013 Small Lower9512522025-07-18
D8199512530G4 NiTi Lingual Wire .013 Medium Upper9512532025-07-18
D8199512540G4 NiTi Lingual Wire .013 Medium Lower9512542025-07-18
D8199512550G4 NiTi Lingual Wire .013 Large Upper9512552025-07-18
D8199512560G4 NiTi Lingual Wire .013 Large Lower9512562025-07-18
D8199512570G4 NiTi Lingual Wire .016 Small Upper9512572025-07-18
D8199512580G4 NiTi Lingual Wire .016 Small Lower9512582025-07-18
D8199512590G4 NiTi Lingual Wire .016 Medium Upper9512592025-07-18
D8199512600G4 NiTi Lingual Wire .016 Medium Lower9512602025-07-18
D8199512610G4 NiTi Lingual Wire .016 Large Upper9512612025-07-18
D8199512620G4 NiTi Lingual Wire .016 Large Lower9512622025-07-18
D8199015462Printed Upper Crown Pack for Herbst UL59015462025-04-03
D8199015472Printed Upper Crown Pack for Herbst UL69015472025-04-03

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Primary DI, Brand, Company table
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00816063023180Invisalign ARTAlign Technology, Inc.NXC2026-02-25
D175H3DMTA91MemoryTech AlignersHype Align Clear Orthodontics LimitadaNXC2026-02-10
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00816063023784lnvisalign Specifix Attachment System (include Engagement Features)Align Technology, Inc.NXC2026-02-09
06956748701997OrthoArchWuxi EA Medical Instruments Technologies Limited.NXC2026-02-04
06956748702055Angel AlignerWuxi EA Medical Instruments Technologies Limited.NXC2026-02-04
06956748702147Angel AlignerWuxi EA Medical Instruments Technologies Limited.NXC2026-02-04
06956748702390SimplyClearWuxi EA Medical Instruments Technologies Limited.NXC2026-02-04
06956748709429Angel AlignerWuxi EA Medical Instruments Technologies Limited.NXC2026-02-04
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00860012168514ArchformArchform Inc.NXC2025-07-22
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00860013903107LuxCreo Clear Aligner SystemLuxcreo IncNXC2025-04-18
00860013903114LuxCreo Clear Aligner SystemLuxcreo IncNXC2025-04-18
00816063022800Invisalign Pre-Formed Attachment System Align Technology, Inc.NXC2025-02-28
00810060226346Blue Sky Bio, LLC.BLUE SKY BIO LLCNXC2025-02-20
D769NWRET0Naturally WhitePARK DENTAL RESEARCH CORPNXC2025-01-10
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