FDA.reportPublic FDA data

Orthodontic Bracket

Primary DI
08806145455192
Brand
Orthodontic Bracket
Company
DENTOS Inc.
Model
MTB-1
Published
2018-09-14
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

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
08806145455192PrimaryGS10
08806145455239Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08806145455192088061454551928806145455192
08806145455239088061454552398806145455239

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
688355973
Device count
10
Premarket exempt
true
Kit
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
08806145440105Dental ForcepCF2018-09-17
08806145440112Dental ForcepMCF2018-09-17
08806145465276Dental ForcepEF-L2018-09-17
08806145465283Dental ForcepEF-U2018-09-17
08806145440129Orthodontic DriverLHD-B+DT-L2025-05-02
08806145440136Orthodontic DriverLHD-B+DT-S2025-05-02
08806145440143Orthodontic DriverNLHD+ST-L2025-05-02
08806145440150Orthodontic DriverNLHD+ST-S2025-05-02
08806145440167Orthodontic DriverNLHD-S+ST-L2025-05-02
08806145440174Orthodontic DriverNLHD-S+ST-S2025-05-02
08806145484086Orthodontic DriverNLHD-S2025-05-02
08806145484895Plier, OrthodonticNTDP-T2025-05-02
08806145484901Plier, OrthodonticNTDP-S2025-05-02
08806145484918Plier, OrthodonticCBRP2025-05-02
08806145455208Orthodontic BracketMTB-22018-09-14
08806145455215Orthodontic BracketTLB-L2018-09-14
08806145455222Orthodontic BracketTLB-U2018-09-14
08806145471352Orthodontic Bracket2in1-U-122018-06-08
08806145471369Orthodontic Bracket2in1-U-32018-06-08
08806145471376Orthodontic Bracket2in1-U-4572018-06-08

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
00197998064166SolventumSolventum 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