FDA.report

KIT ARCHWIRE SEQUENCE HEAVY

Primary DI
07908470708798
Brand
KIT ARCHWIRE SEQUENCE HEAVY
Company
ORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDA
Model
51.35.2803
Device description
KIT ARCHWIRE SEQUENCE HEAVY
Published
2026-05-26
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

Related Records

Product Codes

CodeName
DZCWire, Orthodontic

Product Code Classifications

CodeDeviceSpecialtyClass
DZCWire, OrthodonticDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
07908470708798PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
07908470708798079084707087987908470708798

GMDN Terms

TermDefinition
Orthodontic archwireA dental wire in the shape of an arch used with orthodontic attachments (orthodontic brackets) that are affixed to the crowns/surfaces of two or more teeth in order to cause/guide tooth movement. This is a single-patient device intended to be used for the duration of the treatment (single-use) before being discarded.

Regulatory Flags

DUNS number
898330003
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
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 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
07908611202772CERAMIC BRACKET ICERAM MBT 0.022 L5R (45) - 1UN10.84.22452026-05-26
07908611204103CERAMIC MINI TUBE -10UN21.02.20042026-05-26
07908611204158ICERAM CERAMIC BUTTON FOR BONDING - 2UN30.10.30022026-05-26

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
07908470701294STAINLESS STEEL - WIRE ROUND 0.014 - UPPER - 12UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDADZC2026-05-26
07908470701355STAINLESS STEEL - WIRE RECTANGULAR 0.019X0.025 - UPPER - 12UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDADZC2026-05-26
07908611216014NEW EUROPA I - FLEXY NITI S.E. ROUND OVOID WIRE 0.012 UPPER -10UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDADZC2026-05-26
07908611216021NEW EUROPA I - FLEXY NITI S.E. ROUND OVOID WIRE 0.014 UPPER -10UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDADZC2026-05-26
07908611216038NEW EUROPA I - FLEXY NITI S.E. ROUND OVOID WIRE 0.016 UPPER -10UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDADZC2026-05-26
07908611216045NEW EUROPA I - FLEXY NITI S.E. ROUND OVOID WIRE 0.018 UPPER -10UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDADZC2026-05-26
07908611216052NEW EUROPA I - FLEXY NITI S.E. ROUND OVOID WIRE 0.020 UPPER -10UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDADZC2026-05-26
07908611216069NEW EUROPA I - FLEXY NITI S.E. OVOID SQ WIRE 0.016X0.016 UPPER -10 UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDADZC2026-05-26
07908611216076NEW EUROPA I - FLEXY NITI S.E. RECT OVOID WIRE 0.016X0.022 UPPER-10 UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDADZC2026-05-26
07908611216083NEW EUROPA I - FLEXY NITI S.E. RECT OVOID WIRE 0.017X0.025 UPPER-10 UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDADZC2026-05-26
07908611216090NEW EUROPA I - FLEXY NITI S.E. RECT OVOID WIRE 0.018X0.025 UPPER-10 UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDADZC2026-05-26
07908611216106NEW EUROPA I - FLEXY NITI S.E. RECT OVOID WIRE 0.019X0.025 UPPER-10 UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDADZC2026-05-26
07908611216113NEW EUROPA I - FLEXY NITI S.E. RECT OVOID WIRE 0.021X0.025 UPPER-10 UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDADZC2026-05-26
07908611216120NEW EUROPA I - FLEXY NITI S.E. ROUND OVOID WIRE 0.012 LOWER-10 UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDADZC2026-05-26
07908611216137NEW EUROPA I - FLEXY NITI S.E. ROUND OVOID WIRE 0.014 LOWER-10 UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDADZC2026-05-26
07908611216144NEW EUROPA I - FLEXY NITI S.E. ROUND OVOID WIRE 0.016 LOWER-10 UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDADZC2026-05-26
07908611216151NEW EUROPA I - FLEXY NITI S.E. ROUND OVOID WIRE 0.018 LOWER-10 UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDADZC2026-05-26
07908611216168NEW EUROPA I - FLEXY NITI S.E. ROUND OVOID WIRE 0.020 LOWER-10 UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDADZC2026-05-26
07908611216175NEW EUROPA I - FLEXY NITI S.E. OVOID SQ WIRE 0.016X0.016 LOWER-10 UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDADZC2026-05-26
07908611216182NEW EUROPA I - FLEXY NITI S.E. RECT OVOID WIRE 0.016X0.022 LOWER-10 UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDADZC2026-05-26
07908611216199NEW EUROPA I - FLEXY NITI S.E. RECT OVOID WIRE 0.017X0.025 LOWER-10 UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDADZC2026-05-26
07908611216205NEW EUROPA I - FLEXY NITI S.E. RECT OVOID WIRE 0.018X0.025 LOWER-10 UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDADZC2026-05-26
07908611216212NEW EUROPA I - FLEXY NITI S.E. RECT OVOID WIRE 0.019X0.025 LOWER-10 UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDADZC2026-05-26
07908611216229NEW EUROPA I - FLEXY NITI S.E. RECT OVOID WIRE 0.021X0.025 LOWER-10 UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDADZC2026-05-26
07908611216236NEW EUROPA I - SS ROUND OVOID WIRE 0.012 UPPER-10 UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDADZC2026-05-26
07908611216243NEW EUROPA I - SS ROUND OVOID WIRE 0.014 UPPER-10 UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDADZC2026-05-26
07908611216267NEW EUROPA I - SS ROUND OVOID WIRE 0.018 UPPER-10 UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDADZC2026-05-26
07908611216274NEW EUROPA I - SS ROUND OVOID WIRE 0.020 UPPER-10 UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDADZC2026-05-26
07908611216281NEW EUROPA I - SS OVOID SQUARE WIRE 0.016X0.016 UPPER-10 UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDADZC2026-05-26
07908611216298NEW EUROPA I - SS OVOID RECTANGULAR WIRE 0.016X0.022 UPPER-10 UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDADZC2026-05-26