FDA.reportPublic FDA data

Absolute® Clear Aligners

Primary DI
00190707101282
Brand
Absolute® Clear Aligners
Company
Ortho Organizers, Inc.
Model
140-AL19
Device description
Absolute® Clear Aligners
Published
2022-06-23
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190707101282PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190707101282001907071012821907071012820190707101282

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
062165188
Device count
1
DM exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00190707089078Endura Plus Instruments201-1212020-07-13
00190707000738Envision701-005-52016-09-24
00190707000745Envision701-006-52016-09-24
00190707000752Envision701-021-52016-09-24
00190707000769Envision701-022-52016-09-24
00190707000776Envision701-033-52016-09-24
00190707000783Envision701-034-52016-09-24
00190707000790Envision701-035-52016-09-24
00190707000806Envision701-036-52016-09-24
00190707000813Envision701-037-52016-09-24
00190707000820Envision701-038-52016-09-24
00190707000837Envision701-057-52016-09-24
00190707000844Envision701-058-52016-09-24
00190707000851Envision701-059-52016-09-24
00190707000868Envision701-060-52016-09-24
00190707000875Envision701-067-52016-09-24
00190707000882Envision701-068-52016-09-24
00190707000899Envision701-069-52016-09-24
00190707000905Envision701-070-52016-09-24
00190707000912Envision701-087-52016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06974361420071Zhejiang YinchiliZhejiang Yinchili Medical Technology Co., Ltd.NXC2026-03-23
06974361421436Zhejiang YinchiliZhejiang Yinchili Medical Technology Co., Ltd.NXC2026-03-23
00816063023180Invisalign ARTAlign Technology, Inc.NXC2026-02-25
D175H3DMTA91MemoryTech AlignersHype Align Clear Orthodontics LimitadaNXC2026-02-10
00816063023777Invisalign Specifix Attachment SystemAlign Technology, Inc.NXC2026-02-09
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
D769CMIAL0Clear MovesPARK DENTAL RESEARCH CORPNXC2025-12-16
E239D361501Primeprint Direct AlignerDreve Dentamid GmbHNXC2025-11-25
00816063021377Invisalign Go ExpressAlign Technology, Inc.NXC2025-09-15
00860014476105SmileSet Nighttime AlignersOrtho Dental Lab LLCNXC2025-09-03
00860012825509SmileSet All-Day AlignersOrtho Dental Lab LLCNXC2025-08-28
00860012168514ArchformArchform Inc.NXC2025-07-22
00860013140700Clear Force AlignersOhlendorf Co.NXC2025-06-04
00860013140717Clear Express AlignersOhlendorf Co.NXC2025-06-04
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
006522213072483M™ Clarity™3M UNITEK CORPORATIONNXC2024-11-22
006522213072553M™ Clarity™3M UNITEK CORPORATIONNXC2024-11-22
006522213072623M™ Clarity™3M UNITEK CORPORATIONNXC2024-11-22
006522213072793M™ Clarity™3M UNITEK CORPORATIONNXC2024-11-22
006522213072863M™ Clarity™3M UNITEK CORPORATIONNXC2024-11-22
006522213072933M™ Clarity™3M UNITEK CORPORATIONNXC2024-11-22