FDA.reportPublic FDA data

Solventum

Primary DI
00197998073571
Brand
Solventum
Company
Solventum Orthodontics Corporation
Model
5058-9030
Catalog number
5058-9030
Device description
Solventum™ Victory Series™ APC™ Plus Adhesive Coated Second Bicuspid Tubes, 5058-9030, MBT™, UL/UR, -7T/0A, Offset, 0.022, 4/PAC
Published
2026-10-25
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
DYHADHESIVE, BRACKET AND TOOTH CONDITIONER, RESIN

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DYHAdhesive, Bracket And Tooth Conditioner, ResinDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00197998073571PrimaryGS10
00197998652257Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00197998073571001979980735711979980735710197998073571
00197998652257001979986522571979986522570197998652257

GMDN Terms#

Term, Definition table
TermDefinition
Orthodontic bracket adhesiveA bonding compound, e.g., polymethylmethacrylate (PMMA), used specifically to cement an orthodontic bracket to the surface of a tooth. After application, this device cannot be reused.

Contacts#

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

Regulatory Flags#

DUNS number
119329099
Device count
4
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
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
00197998073557SolventumSolventum Orthodontics CorporationDYH2026-10-25
00197998073564SolventumSolventum Orthodontics CorporationDYH2026-10-25
00197998062407SolventumSolventum Orthodontics CorporationDYH2026-10-24
00197998062551SolventumSolventum Orthodontics CorporationDYH2026-10-24
00197998062988SolventumSolventum Orthodontics CorporationDYH2026-10-24
00197998062995SolventumSolventum Orthodontics CorporationDYH2026-10-24
00197998063008SolventumSolventum Orthodontics CorporationDYH2026-10-24
00197998063015SolventumSolventum Orthodontics CorporationDYH2026-10-24
00197998063169SolventumSolventum Orthodontics CorporationDYH2026-10-24
00197998063176SolventumSolventum Orthodontics CorporationDYH2026-10-24
00197998063183SolventumSolventum Orthodontics CorporationDYH2026-10-24
00197998063190SolventumSolventum Orthodontics CorporationDYH2026-10-24
00197998063206SolventumSolventum Orthodontics CorporationDYH2026-10-24
00197998063213SolventumSolventum Orthodontics CorporationDYH2026-10-24
00197998063244SolventumSolventum Orthodontics CorporationDYH2026-10-24
00197998063251SolventumSolventum Orthodontics CorporationDYH2026-10-24
00197998063268SolventumSolventum Orthodontics CorporationDYH2026-10-24
00197998063275SolventumSolventum Orthodontics CorporationDYH2026-10-24
00197998063299SolventumSolventum Orthodontics CorporationDYH2026-10-24
00197998063305SolventumSolventum Orthodontics CorporationDYH2026-10-24
00197998063312SolventumSolventum Orthodontics CorporationDYH2026-10-24
00197998063329SolventumSolventum Orthodontics CorporationDYH2026-10-24
00197998063947SolventumSolventum Orthodontics CorporationDYH2026-10-24
00197998063954SolventumSolventum Orthodontics CorporationDYH2026-10-24
00197998063961SolventumSolventum Orthodontics CorporationDYH2026-10-24
00197998063978SolventumSolventum Orthodontics CorporationDYH2026-10-24
00197998063985SolventumSolventum Orthodontics CorporationDYH2026-10-24
00197998063992SolventumSolventum Orthodontics CorporationDYH2026-10-24
00197998064005SolventumSolventum Orthodontics CorporationDYH2026-10-24
00197998064012SolventumSolventum Orthodontics CorporationDYH2026-10-24