FDA.reportPublic FDA data

Solventum

Primary DI
00197998064166
Brand
Solventum
Company
Solventum Orthodontics Corporation
Model
017-684
Catalog number
017-684
Device description
Solventum™ Victory Series™ Metal Brackets, 017-684, UR4,5, -7T/0A, DHk, 0.022, 5/PAC
Published
2026-10-24
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
EJFBRACKET, METAL, ORTHODONTIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EJFBracket, Metal, OrthodonticDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00197998064166PrimaryGS10
00197998647932Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00197998064166001979980641661979980641660197998064166
00197998647932001979986479321979986479320197998647932

GMDN Terms#

Term, Definition table
TermDefinition
Orthodontic bracket, metalA metallic device that is bonded to an orthodontic band, or directly to a tooth, to hold an orthodontic wire and/or other appliance (e.g., rubber bands) used to apply pressure to the tooth in order to alter the position of the tooth. This is a single-patient device intended to be used for the duration of the treatment (single-use) before being discarded.

Contacts#

Phone, Email table
PhoneEmail
+1(800)634-2249regulatoryrequests@solventum.com

Regulatory Flags#

DUNS number
119329099
Device count
5
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
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
00197998062346Solventum017-447017-4472026-10-24
00197998062353Solventum017-452017-4522026-10-24
00197998062360Solventum017-547017-5472026-10-24
00197998062377Solventum017-548017-5482026-10-24
00197998062384Solventum017-551017-5512026-10-24
00197998062391Solventum017-552017-5522026-10-24
00197998062407Solventum3017-4523017-4522026-10-24
00197998062551Solventum5017-4525017-4522026-10-24
00197998062803Solventum017-448017-4482026-10-24
00197998062988Solventum5017-4485017-4482026-10-24
00197998062995Solventum5017-5475017-5472026-10-24
00197998063008Solventum5017-5485017-5482026-10-24
00197998063015Solventum5017-5525017-5522026-10-24
00197998063169Solventum3017-7753017-7752026-10-24
00197998063176Solventum3017-7763017-7762026-10-24
00197998063183Solventum3017-7773017-7772026-10-24
00197998063190Solventum3017-7783017-7782026-10-24
00197998063206Solventum3017-7923017-7922026-10-24
00197998063213Solventum3017-8813017-8812026-10-24
00197998063244Solventum3017-8823017-8822026-10-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00197998062346SolventumSolventum Orthodontics CorporationEJF2026-10-24
00197998062353SolventumSolventum Orthodontics CorporationEJF2026-10-24
00197998062360SolventumSolventum Orthodontics CorporationEJF2026-10-24
00197998062377SolventumSolventum Orthodontics CorporationEJF2026-10-24
00197998062384SolventumSolventum Orthodontics CorporationEJF2026-10-24
00197998062391SolventumSolventum Orthodontics CorporationEJF2026-10-24
00197998062803SolventumSolventum Orthodontics CorporationEJF2026-10-24
00197998064142SolventumSolventum Orthodontics CorporationEJF2026-10-24
00197998064159SolventumSolventum Orthodontics CorporationEJF2026-10-24
00197998064173SolventumSolventum Orthodontics CorporationEJF2026-10-24
00197998064180SolventumSolventum Orthodontics CorporationEJF2026-10-24
00197998064197SolventumSolventum Orthodontics CorporationEJF2026-10-24
00197998064203SolventumSolventum Orthodontics CorporationEJF2026-10-24
00197998064272SolventumSolventum Orthodontics CorporationEJF2026-10-24
00197998064289SolventumSolventum Orthodontics CorporationEJF2026-10-24
00197998064296SolventumSolventum Orthodontics CorporationEJF2026-10-24
00197998064302SolventumSolventum Orthodontics CorporationEJF2026-10-24
00197998064319SolventumSolventum Orthodontics CorporationEJF2026-10-24
00197998064326SolventumSolventum Orthodontics CorporationEJF2026-10-24
00197998064333SolventumSolventum Orthodontics CorporationEJF2026-10-24
00197998064340SolventumSolventum Orthodontics CorporationEJF2026-10-24
00197998064357SolventumSolventum Orthodontics CorporationEJF2026-10-24
00197998064364SolventumSolventum Orthodontics CorporationEJF2026-10-24
00197998064418SolventumSolventum Orthodontics CorporationEJF2026-10-24
00197998064425SolventumSolventum Orthodontics CorporationEJF2026-10-24
00197998064432SolventumSolventum Orthodontics CorporationEJF2026-10-24
00197998064449SolventumSolventum Orthodontics CorporationEJF2026-10-24
00197998064456SolventumSolventum Orthodontics CorporationEJF2026-10-24
00197998064463SolventumSolventum Orthodontics CorporationEJF2026-10-24
00197998064470SolventumSolventum Orthodontics CorporationEJF2026-10-24