FDA.reportPublic FDA data

MIRABAY

Primary DI
05061075020695
Brand
MIRABAY
Company
Mirabay Orthodontics Corp.
Model
5O1-0070
Catalog number
5O1-0070
Device description
OPTIMAL SYMMETRY SE NiTi 0.016 x 0.025 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
05061075020695PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05061075020695050610750206955061075020695

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
00840456209882JMUJMU DENTAL, INCDZC2026-06-25
00840456209899JMUJMU DENTAL, INCDZC2026-06-25
00840456209905JMUJMU DENTAL, INCDZC2026-06-25
00840456209912JMUJMU DENTAL, INCDZC2026-06-25
00840456209929JMUJMU DENTAL, INCDZC2026-06-25
00840456209936JMUJMU DENTAL, INCDZC2026-06-25
00840456209943JMUJMU DENTAL, INCDZC2026-06-25
00840456209950JMUJMU DENTAL, INCDZC2026-06-25
00840456209967JMUJMU DENTAL, INCDZC2026-06-25
00840456209974JMUJMU DENTAL, INCDZC2026-06-25
00840456209981JMUJMU DENTAL, INCDZC2026-06-25
00840456209998JMUJMU DENTAL, INCDZC2026-06-25
00840456210000JMUJMU DENTAL, INCDZC2026-06-25
00840456210017JMUJMU DENTAL, INCDZC2026-06-25
00840456210024JMUJMU DENTAL, INCDZC2026-06-25
00840456210031JMUJMU DENTAL, INCDZC2026-06-25
00840456210048JMUJMU DENTAL, INCDZC2026-06-25
00840456210055JMUJMU DENTAL, INCDZC2026-06-25
00840456210062JMUJMU DENTAL, INCDZC2026-06-25
00840456210079JMUJMU DENTAL, INCDZC2026-06-25
00840456210086JMUJMU DENTAL, INCDZC2026-06-25
00840456210093JMUJMU DENTAL, INCDZC2026-06-25
00840456210109JMUJMU DENTAL, INCDZC2026-06-25
00840456210116JMUJMU DENTAL, INCDZC2026-06-25
00840456210123JMUJMU DENTAL, INCDZC2026-06-25
00840456210130JMUJMU DENTAL, INCDZC2026-06-25
00840456211182JMUJMU DENTAL, INCDZC2026-06-25
00840456211199JMUJMU DENTAL, INCDZC2026-06-25
00840456211205JMUJMU DENTAL, INCDZC2026-06-25
00840456211212JMUJMU DENTAL, INCDZC2026-06-25