FDA.reportPublic FDA data

Invisalign Cheek Retractor, Medium

Primary DI
00816063021131
Brand
Invisalign Cheek Retractor, Medium
Company
Align Technology, Inc.
Model
202430
Device description
Cheek Retractor
Published
2022-12-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
EIGRetractor, All Types

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EIGRetractor, All TypesDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816063021131PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816063021131008160630211318160630211310816063021131

GMDN Terms#

Term, Definition table
TermDefinition
Dental cheek retractor, home-useA hands-free, self-retaining frame intended to be used in the home by a patient to retract the lips/cheeks to facilitate viewing of the teeth (e.g., to allow photographs to be taken and sent to a healthcare professional). It is a synthetic polymer device designed to be placed in and around the lips/cheeks; it is not intended to be placed between the teeth (i.e., not a mouth gag). This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
013831768
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00816063022305Invisalign System with Integrated Buttons50332026-09-29
00816063023418Invisalign Palatal Expander with Engagement Features50272026-09-29
00816063023425Invisalign Palatal Holder with Engagement Features50282026-09-29
00816063020172Vivera Realine85672016-09-24
00816063023791Cleaning Crystals, Packette2272872026-07-21
00816063021506Kit, Pliers Set Detail/Eraser760182022-12-06
00816063020097Realine85542016-09-24
00816063020240The Signature Smile90162017-11-10
00816063020448Invisalign Signature Smile90212018-06-15
00816063020455Invisalign Signature Plus Smile90202018-06-15
00816063020462Invisalign Deluxe Smile90192018-06-15
00816063023029iTero Element™ 5D imaging system2176182026-07-22
00816063022312iTero Lumina Pro DOA2219592026-06-25
00816063021735iTero Element 5D scanning unit, service2069552026-06-23
00816063022169Attachment Template1000122023-07-24
00816063023180Invisalign ART90502026-02-25
00816063023777Invisalign Specifix Attachment System50352026-02-09
00816063023784lnvisalign Specifix Attachment System (include Engagement Features)50362026-02-09
00816063023760Gumlines2267972026-01-01
00816063023173iTero Lumina – PC cfg, Interface Box2176222025-09-16

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Primary DI, Brand, Company table
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00883205029126OpalDamULTRADENT PRODUCTS, INC.EIG2026-08-22
00883205029133OpalDamULTRADENT PRODUCTS, INC.EIG2026-08-22
00883205029140OpalDamULTRADENT PRODUCTS, INC.EIG2026-08-22
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00190776426491MillenniumAvalign Technologies, Inc.EIG2026-08-18
00190776426514MillenniumAvalign Technologies, Inc.EIG2026-08-18
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00190776426538MillenniumAvalign Technologies, Inc.EIG2026-08-18
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G8791030260DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIG2026-08-15
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G879103185M0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIG2026-08-15
G879103185S0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIG2026-08-15
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G879LB4013DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIG2026-08-15
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