FDA.reportPublic FDA data

Solventum

Primary DI
00197998253447
Brand
Solventum
Company
Solventum Orthodontics Corporation
Model
067-520
Catalog number
067-520
Device description
Solventum™ Victory Series™ Buccal Tubes, 067-520, MBT™, LL, 1M, SglCv, -20T/0Off, .018, 4.3mm, 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
DZDTUBE, ORTHODONTIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZDTube, OrthodonticDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00197998253447PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00197998253447001979982534471979982534470197998253447

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
1
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
00197998070198SolventumSolventum Orthodontics CorporationDZD2026-10-24
00197998070204SolventumSolventum Orthodontics CorporationDZD2026-10-24
00197998070211SolventumSolventum Orthodontics CorporationDZD2026-10-24
00197998075063SolventumSolventum Orthodontics CorporationDZD2026-10-24
00197998075674SolventumSolventum Orthodontics CorporationDZD2026-10-24
00197998101670SolventumSolventum Orthodontics CorporationDZD2026-10-24
00197998101694SolventumSolventum Orthodontics CorporationDZD2026-10-24
00197998107887SolventumSolventum Orthodontics CorporationDZD2026-10-24
00197998107900SolventumSolventum Orthodontics CorporationDZD2026-10-24
00197998253386SolventumSolventum Orthodontics CorporationDZD2026-10-24
00197998253393SolventumSolventum Orthodontics CorporationDZD2026-10-24
00197998253409SolventumSolventum Orthodontics CorporationDZD2026-10-24
00197998253416SolventumSolventum Orthodontics CorporationDZD2026-10-24
00197998253423SolventumSolventum Orthodontics CorporationDZD2026-10-24
00197998253430SolventumSolventum Orthodontics CorporationDZD2026-10-24
00197998253454SolventumSolventum Orthodontics CorporationDZD2026-10-24
00197998253461SolventumSolventum Orthodontics CorporationDZD2026-10-24
00197998253478SolventumSolventum Orthodontics CorporationDZD2026-10-24
00197998253485SolventumSolventum Orthodontics CorporationDZD2026-10-24
00197998253492SolventumSolventum Orthodontics CorporationDZD2026-10-24
00197998253508SolventumSolventum Orthodontics CorporationDZD2026-10-24
00197998253515SolventumSolventum Orthodontics CorporationDZD2026-10-24
00197998253522SolventumSolventum Orthodontics CorporationDZD2026-10-24
00197998253539SolventumSolventum Orthodontics CorporationDZD2026-10-24
00197998253546SolventumSolventum Orthodontics CorporationDZD2026-10-24
00197998253553SolventumSolventum Orthodontics CorporationDZD2026-10-24
00197998253560SolventumSolventum Orthodontics CorporationDZD2026-10-24
00197998253577SolventumSolventum Orthodontics CorporationDZD2026-10-24
00197998253584SolventumSolventum Orthodontics CorporationDZD2026-10-24
00197998253591SolventumSolventum Orthodontics CorporationDZD2026-10-24