FDA.reportPublic FDA data

Clarity™

Primary DI
00197998216633
Brand
Clarity™
Company
Solventum Orthodontics Corporation
Model
359-460
Catalog number
359-460
Device description
Clarity Aligners-Retainer, Dual Arch
Published
2026-04-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DYJRETAINER, SCREW EXPANSION, ORTHODONTIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DYJRetainer, Screw Expansion, OrthodonticDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00197998216633PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00197998216633001979982166331979982166330197998216633

GMDN Terms#

Term, Definition table
TermDefinition
Orthodontic retainerAn orthodontic appliance, bonded or removable, intended to be used on a single patient to maintain teeth in corrected positions during the period of functional adaptation following corrective treatment. This appliance, also referred to as a positioner, is also used to maintain the positions of the teeth and jaws gained by orthodontic procedures.

Contacts#

Phone, Email table
PhoneEmail
+1(800)228-3957regulatoryrequests@solventum.com

Regulatory Flags#

DUNS number
119329099
Device count
1
Premarket exempt
true
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
00197998216121Clarity™355-200355-2002026-04-25
00197998216138Clarity™355-201355-2012026-04-25
00197998216152Clarity™355-203355-2032026-04-25
00197998216169Clarity™355-204355-2042026-04-25
00197998216176Clarity™355-205355-2052026-04-25
00197998216398Clarity™359-132359-1322026-04-25
00197998216428Clarity™359-135359-1352026-04-25
00197998216435Clarity™359-142359-1422026-04-25
00197998216480Clarity™359-232359-2322026-04-25
00197998216527Clarity™359-242359-2422026-04-25
00197998216534Clarity™359-243359-2432026-04-25
00197998216572Clarity™359-342359-3422026-04-25
00197998216596Clarity™359-344359-3442026-04-25
00197998216657Clarity™359-701359-7012026-04-25
00197998216664Clarity™359-702359-7022026-04-25
00197998216671Clarity™359-703359-7032026-04-25
00197998382772Clarity™359-825359-8252026-04-25
00197998382796Clarity™359-835359-8352026-04-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840456221761JMUJMU DENTAL, INCDYJ2026-05-11
00840456221778JMUJMU DENTAL, INCDYJ2026-05-11
D775AHAD0Hawley Retainer with Adams ClaspsGreat Lakes Dental Technologies, Ltd.DYJ2026-05-10
D775AHAR0Hawley Retainer with Arrow ClaspsGreat Lakes Dental Technologies, Ltd.DYJ2026-05-10
D775AHBC0Hawley Retainer with Ball ClaspsGreat Lakes Dental Technologies, Ltd.DYJ2026-05-10
D775AHCC0Hawley Retainer with Circumferential ClaspsGreat Lakes Dental Technologies, Ltd.DYJ2026-05-10
D775BMARPEL0MARPEGreat Lakes Dental Technologies, Ltd.DYJ2026-05-10
D775BMARPEP0MARPEGreat Lakes Dental Technologies, Ltd.DYJ2026-05-10
D775BMMT0MemotainGreat Lakes Dental Technologies, Ltd.DYJ2026-05-10
10371347023326Advance Dental ProductsThe Atlanta Dental Supply CompanyDYJ2026-04-14
10371347023333Advance Dental ProductsThe Atlanta Dental Supply CompanyDYJ2026-04-14
10371347023340Advance Dental ProductsThe Atlanta Dental Supply CompanyDYJ2026-04-14
10371347023357Advance Dental ProductsThe Atlanta Dental Supply CompanyDYJ2026-04-14
D775AEA0Expansion ApplianceGreat Lakes Dental Technologies, Ltd.DYJ2026-04-13
D775AH0Hawley RetainerGreat Lakes Dental Technologies, Ltd.DYJ2026-04-13
D775BKS0Keles SliderGreat Lakes Dental Technologies, Ltd.DYJ2026-04-13
00190746202766PowerScopeAMERICAN ORTHODONTICS CORPORATIONDYJ2026-04-08
08033707104827LEONE SPALEONE SPADYJ2026-04-01
08033707104834LEONE SPALEONE SPADYJ2026-04-01
08800197901621ATOZ KeyMK Meditech Inc.DYJ2025-11-03
J011430120310prime4me®DENTAURUM GmbH & Co.KGDYJ2025-10-09
J011430120410prime4me®DENTAURUM GmbH & Co.KGDYJ2025-10-09
07895742296612MorelliDental Morelli LtdaDYJ2025-09-10
07895742296629MorelliDental Morelli LtdaDYJ2025-09-10
07895742296636MorelliDental Morelli LtdaDYJ2025-09-10
07895742296643MorelliDental Morelli LtdaDYJ2025-09-10
J011430120400prime4me®DENTAURUM GmbH & Co.KGDYJ2025-07-10
J01854551HerbstScheu-Dental GmbHDYJ2024-11-19
J01854561HerbstScheu-Dental GmbHDYJ2024-11-19
J01854571IST® Appliance / HerbstScheu-Dental GmbHDYJ2024-11-19