FDA.reportPublic FDA data

MIRABAY

Primary DI
05061075020633
Brand
MIRABAY
Company
Mirabay Orthodontics Corp.
Model
5O1-4064
Catalog number
5O1-4064
Device description
OPTIMAL SYMMETRY SE NiTi IND W/STOPS 0.014 UP PK10
Published
2025-02-03
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
DZCWIRE, ORTHODONTIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZCWire, OrthodonticDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05061075020633PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05061075020633050610750206335061075020633

GMDN Terms#

Term, Definition table
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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(949) 216-4758mirabayorthodontics@gmail.com

Regulatory Flags#

DUNS number
119374260
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05065025111884MIRABAY172-5003172-50032026-03-19
05065025111891MIRABAY172-5345172-53452026-03-19
05065025111907MIRABAY173-5345173-53452026-03-19
05065025111914MIRABAY174-5345174-53452026-03-19
05065025111921MIRABAY175-5345175-53452026-03-19
05065025111723MIRABAY051-7605051-76052026-03-17
05065025111730MIRABAY155-7605155-76052026-03-17
05065025111747MIRABAY156-7605156-76052026-03-17
05065025111754MIRABAY151-7605151-76052026-03-17
05065025111761MIRABAY152-7605152-76052026-03-17
05065025111778MIRABAY278-6301278-63012026-03-17
05065025111785MIRABAY278-6302278-63022026-03-17
05065025111792MIRABAY278-6303278-63032026-03-17
05065025111808MIRABAY278-6304278-63042026-03-17
05065025111815MIRABAY278-6101278-61012026-03-17
05065025111822MIRABAY278-6102278-61022026-03-17
05065025111839MIRABAY278-6103278-61032026-03-17
05065025111846MIRABAY278-6104278-61042026-03-17
05065025111853MIRABAY252-6401252-64012026-03-17
05065025111860MIRABAY252-7341252-73412026-03-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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
07908470708798KIT ARCHWIRE SEQUENCE HEAVYORTHOMETRIC - 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