FDA.reportPublic FDA data

MIRABAY

Primary DI
05061075022149
Brand
MIRABAY
Company
Mirabay Orthodontics Corp.
Model
611-0002
Catalog number
611-0002
Device description
CLOSED COIL SPRING MD NITI 0.011 X 0.030 12MM 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
OTC
false
Sterile
false
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
05061075022149PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05061075022149050610750221495061075022149

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
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
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 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

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Primary DI, Brand, Company table
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00810126380364Distal Jet 4 BandsDigital Dental Laboratories, IncECO2026-02-25
00810126380371Distal jet completeDigital Dental Laboratories, IncECO2026-02-25
00810126380388Dmax 2000Digital Dental Laboratories, IncECO2026-02-25
00810126380395Dmax/RPE 2000Digital Dental Laboratories, IncECO2026-02-25
00810126380401DMJ 2000Digital Dental Laboratories, IncECO2026-02-25
00810126380418EAS MJX 2000Digital Dental Laboratories, IncECO2026-02-25
00810126380425EAS MSC 2000Digital Dental Laboratories, IncECO2026-02-25
00810126380432EAS MSX 2000Digital Dental Laboratories, IncECO2026-02-25
00810126380449Exspider applianceDigital Dental Laboratories, IncECO2026-02-25
00810126380456Exspider Appliance 2 BandsDigital Dental Laboratories, IncECO2026-02-25
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00810126380494Fisher tad holding applianceDigital Dental Laboratories, IncECO2026-02-25
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00810126380517Fixed retaining appliances - rpeDigital Dental Laboratories, IncECO2026-02-25
00810126380524Galella Tongue Bead ApplianceDigital Dental Laboratories, IncECO2026-02-25
00810126380531Haas applianceDigital Dental Laboratories, IncECO2026-02-25
00810126380548HAAS Appliance with BandsDigital Dental Laboratories, IncECO2026-02-25
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00810126380579Habit breaking appliances - banded hyrax with cribDigital Dental Laboratories, IncECO2026-02-25
00810126380586Habit breaking appliances - galella tongue bead applianceDigital Dental Laboratories, IncECO2026-02-25
00810126380593Habit breaking appliances - limp bumperDigital Dental Laboratories, IncECO2026-02-25
00810126380609Halterman applianceDigital Dental Laboratories, IncECO2026-02-25
00810126380616Herbst applianceDigital Dental Laboratories, IncECO2026-02-25
00810126380623Herbst Appliance with bandsDigital Dental Laboratories, IncECO2026-02-25