FDA.reportPublic FDA data

ORTHODONTIC BITE TURBO - 10UN

Primary DI
07908611212665
Brand
ORTHODONTIC BITE TURBO - 10UN
Company
ORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDA
Model
30.10.4003
Device description
ORTHODONTIC BITE TURBO - 10UN
Published
2026-01-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
ECNClamp, Wire, Orthodontic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ECNClamp, Wire, OrthodonticDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07908611212665PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07908611212665079086112126657908611212665

GMDN Terms#

Term, Definition table
TermDefinition
Orthodontic lockA dental device intended to be placed on an orthodontic archwire or rod via screwing, crimping, or soldering, for orthodontic spring activation and/or to prevent the archwire from sliding within the brackets. It may be designed in various forms (e.g., Gurin lock, stop). It does not incorporate a pin or hook. This is a single-patient device that is used for the duration of the treatment (single-use) before being discarded.

Regulatory Flags#

DUNS number
898330003
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07898488904056METAL BRACKET ADVANCED ROTH 0.022 - U1R (11) - 100UN10.10.23112026-05-26
07898488904063METAL BRACKET ADVANCED ROTH 0.022 - U2R (12) - 100UN10.10.23122026-05-26
07898488904070METAL BRACKET ADVANCED ROTH 0.022 - U3R (13) - 100UN10.10.23132026-05-26
07898488904087METAL BRACKET ADVANCED ROTH 0.022 - U45R (14,15) - 100UN10.10.23142026-05-26
07898488904094METAL BRACKET ADVANCED ROTH 0.022 - U1L (21) - 100UN10.10.23212026-05-26
07898488904100METAL BRACKET ADVANCED ROTH 0.022 - U2L (22) - 100UN10.10.23222026-05-26
07898488904117METAL BRACKET ADVANCED ROTH 0.022 - U3L (23) - 100UN10.10.23232026-05-26
07898488904124METAL BRACKET ADVANCED ROTH 0.022 - U45L (24,25) - 100UN10.10.23242026-05-26
07898488904148METAL BRACKET ADVANCED ROTH 0.022 - L3L (33) - 100UN10.10.23332026-05-26
07898488904155METAL BRACKET ADVANCED ROTH 0.022 - L4L (34) - 100UN10.10.23342026-05-26
07898488904162METAL BRACKET ADVANCED ROTH 0.022 - L5L (35) - 100UN10.10.23352026-05-26
07898488904179METAL BRACKET ADVANCED ROTH 0.022 - L3R (43) - 100UN10.10.23432026-05-26
07898488904186METAL BRACKET ADVANCED ROTH 0.022 - L4R (44) - 100UN10.10.23442026-05-26
07898488904193METAL BRACKET ADVANCED ROTH 0.022 - L5R (45) - 100UN10.10.23452026-05-26
07908470701294STAINLESS STEEL - WIRE ROUND 0.014 - UPPER - 12UN51.60.20142026-05-26
07908470701355STAINLESS STEEL - WIRE RECTANGULAR 0.019X0.025 - UPPER - 12UN51.60.25192026-05-26
07908470707678KIT LAUNCH - U-CLIP10.45.23012026-05-26
07908470708798KIT ARCHWIRE SEQUENCE HEAVY51.35.28032026-05-26
07908611202772CERAMIC BRACKET ICERAM MBT 0.022 L5R (45) - 1UN10.84.22452026-05-26
07908611204103CERAMIC MINI TUBE -10UN21.02.20042026-05-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840456221730JMUJMU DENTAL, INCECN2026-05-11
00840456221747JMUJMU DENTAL, INCECN2026-05-11
006522210993343M™ Unitek™ Intraoral Attachments3M UNITEK CORPORATIONECN2026-05-07
00190746203770Weldable CleatAMERICAN ORTHODONTICS CORPORATIONECN2026-04-21
00190746203787Weldable CleatAMERICAN ORTHODONTICS CORPORATIONECN2026-04-21
00190746203794Weldable CleatAMERICAN ORTHODONTICS CORPORATIONECN2026-04-21
00190746203800Weldable CleatAMERICAN ORTHODONTICS CORPORATIONECN2026-04-21
00190746203817Weldable CleatAMERICAN ORTHODONTICS CORPORATIONECN2026-04-21
00190746203824Weldable CleatAMERICAN ORTHODONTICS CORPORATIONECN2026-04-21
00190746203831Bondable CleatAMERICAN ORTHODONTICS CORPORATIONECN2026-04-21
10371347023203Advance Dental ProductsThe Atlanta Dental Supply CompanyECN2026-04-14
10371347023210Advance Dental ProductsThe Atlanta Dental Supply CompanyECN2026-04-14
10371347023227Advance Dental ProductsThe Atlanta Dental Supply CompanyECN2026-04-14
10371347023234Advance Dental ProductsThe Atlanta Dental Supply CompanyECN2026-04-14
10371347023241Advance Dental ProductsThe Atlanta Dental Supply CompanyECN2026-04-14
10371347023258Advance Dental ProductsThe Atlanta Dental Supply CompanyECN2026-04-14
10371347023265Advance Dental ProductsThe Atlanta Dental Supply CompanyECN2026-04-14
10371347023272Advance Dental ProductsThe Atlanta Dental Supply CompanyECN2026-04-14
10371347023289Advance Dental ProductsThe Atlanta Dental Supply CompanyECN2026-04-14
07908611211644CRIMPABLE BALL HOOK - UNIVERSAL - 2.7MM - 10UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAECN2026-01-12
07908611211651CRIMPABLE BALL HOOK - UNIVERSAL - 4,0MM - 10UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAECN2026-01-12
07908611211668BUTTON WITH LONG HOOK FOR BONDING - LEFT - 10UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAECN2026-01-12
07908611212603BUTTON WITH LONG HOOK FOR BONDING - RIGHT - 10UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAECN2026-01-12
07908611212634ORTHODONTIC SPUR - 50UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAECN2026-01-12
07908611212672LINGUAL BUTTON PERFORATED BASE FOR BONDING - 10UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAECN2026-01-12
07908611213815BUTTON WITH CAPLIN HOOK FOR BONDING - 10UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAECN2026-01-12
07908611214928LONG CRIMPABLE HOOK - RECTANGULAR - LEFT - 5UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAECN2026-01-12
07908611214935LONG CRIMPABLE HOOK - RECTANGULAR - RIGHT - 5UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAECN2026-01-12
00190707124267Ortho Technology®Ortho Organizers, Inc.ECN2025-10-17
00190707124274Ortho Technology®Ortho Organizers, Inc.ECN2025-10-17