FDA.reportPublic FDA data

MIRABAY

Primary DI
05061075022163
Brand
MIRABAY
Company
Mirabay Orthodontics Corp.
Model
611-0004
Catalog number
611-0004
Device description
CLOSED COIL SPRING MD NITI 0.011 X 0.030 9MM 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
ECOSPRING, ORTHODONTIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ECOSpring, OrthodonticDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05061075022163PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05061075022163050610750221635061075022163

GMDN Terms#

Term, Definition table
TermDefinition
Orthodontic springA dental device in the shape of a coil intended to be placed around an archwire, a rod, in a bracket, on hooks, pins, and/or between teeth, to apply force (e.g., rotational, uprighting, horizontal) as part of an orthodontic force-producing appliance system. This is a single-patient device that is 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
00190746203992Stainless Steel SpringAMERICAN ORTHODONTICS CORPORATIONECO2026-04-21
10371347023111Advance Dental ProductsThe Atlanta Dental Supply CompanyECO2026-04-14
10371347023128Advance Dental ProductsThe Atlanta Dental Supply CompanyECO2026-04-14
10371347023135Advance Dental ProductsThe Atlanta Dental Supply CompanyECO2026-04-14
10371347023142Advance Dental ProductsThe Atlanta Dental Supply CompanyECO2026-04-14
10371347023159Advance Dental ProductsThe Atlanta Dental Supply CompanyECO2026-04-14
10371347023166Advance Dental ProductsThe Atlanta Dental Supply CompanyECO2026-04-14
10371347023173Advance Dental ProductsThe Atlanta Dental Supply CompanyECO2026-04-14
10371347023180Advance Dental ProductsThe Atlanta Dental Supply CompanyECO2026-04-14
10371347023197Advance Dental ProductsThe Atlanta Dental Supply CompanyECO2026-04-14
07908611215161ORTHODONTIC TORQUE SPRING 17X25 SMALL 10 UN ORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAECO2026-01-12
07908611215178ORTHODONTIC TORQUE SPRING 17X25 MEDIUM 10 UN ORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAECO2026-01-12
07908611215185ORTHODONTIC TORQUE SPRING 17X25 LARGE 10 UN ORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAECO2026-01-12
07908611215192ORTHODONTIC TORQUE SPRING 18X25 SMALL 10 UN ORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAECO2026-01-12
07908611215208ORTHODONTIC TORQUE SPRING 18X25 MEDIUM 10 UN ORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAECO2026-01-12
07908611215215ORTHODONTIC TORQUE SPRING 18X25 LARGE 10 UN ORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAECO2026-01-12
07908611215222ORTHODONTIC TORQUE SPRING 19X25 SMALL 10 UN ORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAECO2026-01-12
07908611215239ORTHODONTIC TORQUE SPRING 19X25 MEDIUM 10 UN ORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAECO2026-01-12
07908611215246ORTHODONTIC TORQUE SPRING 19X25 LARGE 10 UN ORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAECO2026-01-12
10371347019374Advance Dental ProductsThe Atlanta Dental Supply CompanyECO2024-12-27
10371347019381Advance Dental ProductsThe Atlanta Dental Supply CompanyECO2024-12-27
10371347019398Advance Dental ProductsThe Atlanta Dental Supply CompanyECO2024-12-27
10371347019404Advance Dental ProductsThe Atlanta Dental Supply CompanyECO2024-12-27
10371347019411Advance Dental ProductsThe Atlanta Dental Supply CompanyECO2024-12-26
10371347019428Advance Dental ProductsThe Atlanta Dental Supply CompanyECO2024-12-26
10371347014577Advance Dental ProductsThe Atlanta Dental Supply CompanyECO2024-11-15
10371347014553Advance Dental ProductsThe Atlanta Dental Supply CompanyECO2024-08-27
10371347014560Advance Dental ProductsThe Atlanta Dental Supply CompanyECO2024-08-27
10371347014584Advance Dental ProductsThe Atlanta Dental Supply CompanyECO2024-08-27
10371347014591Advance Dental ProductsThe Atlanta Dental Supply CompanyECO2024-08-27