FDA.reportPublic FDA data

Stainless Steel Open Coil Spring

Primary DI
00190707090159
Brand
Stainless Steel Open Coil Spring
Company
Ortho Organizers, Inc.
Model
106-040
Device description
.010 X .030 Stainless Steel Open Coil Spring (3' Spool)
Published
2021-07-14
Public version status
Update
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
NXCAligner, sequential

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ECOSpring, OrthodonticDental1
NXCAligner, SequentialDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190707090159PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190707090159001907070901591907070901590190707090159

GMDN Terms#

Term, Definition table
TermDefinition
Orthodontic progressive alignerA custom-made orthodontic appliance, typically supplied in series intended to be worn in succession and self-changed every few weeks, designed to influence the shape and/or function of the stomatognathic system to correct malocclusions (e.g., underbites, overbites, cross bites, open bites, crooked teeth) and/or other cosmetic and/or structural flaws of teeth and/or jaws. Also described as sequential or successive, the device is custom-made based on an oral impression, self-removable, and is typically made of clear/transparent synthetic polymers (e.g., a thermoformed polycarbonate); a post-treatment orthodontic retainer/positioner may be included with the device. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
062165188
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00190707089078Endura Plus Instruments201-1212020-07-13
00190707000738Envision701-005-52016-09-24
00190707000745Envision701-006-52016-09-24
00190707000752Envision701-021-52016-09-24
00190707000769Envision701-022-52016-09-24
00190707000776Envision701-033-52016-09-24
00190707000783Envision701-034-52016-09-24
00190707000790Envision701-035-52016-09-24
00190707000806Envision701-036-52016-09-24
00190707000813Envision701-037-52016-09-24
00190707000820Envision701-038-52016-09-24
00190707000837Envision701-057-52016-09-24
00190707000844Envision701-058-52016-09-24
00190707000851Envision701-059-52016-09-24
00190707000868Envision701-060-52016-09-24
00190707000875Envision701-067-52016-09-24
00190707000882Envision701-068-52016-09-24
00190707000899Envision701-069-52016-09-24
00190707000905Envision701-070-52016-09-24
00190707000912Envision701-087-52016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07895742274726MorelliDental Morelli LtdaECO2026-06-02
00197998216398Clarity™Solventum Orthodontics CorporationNXC2026-04-25
00197998216428Clarity™Solventum Orthodontics CorporationNXC2026-04-25
00197998216435Clarity™Solventum Orthodontics CorporationNXC2026-04-25
00197998216480Clarity™Solventum Orthodontics CorporationNXC2026-04-25
00197998216527Clarity™Solventum Orthodontics CorporationNXC2026-04-25
00197998216534Clarity™Solventum Orthodontics CorporationNXC2026-04-25
00197998216572Clarity™Solventum Orthodontics CorporationNXC2026-04-25
00197998216596Clarity™Solventum Orthodontics CorporationNXC2026-04-25
00197998216657Clarity™Solventum Orthodontics CorporationNXC2026-04-25
00197998216664Clarity™Solventum Orthodontics CorporationNXC2026-04-25
00197998216671Clarity™Solventum Orthodontics CorporationNXC2026-04-25
00197998382772Clarity™Solventum Orthodontics CorporationNXC2026-04-25
00197998382796Clarity™Solventum Orthodontics CorporationNXC2026-04-25
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
00810060227053Blue Sky Bio, LLC.BLUE SKY BIO LLCNXC2026-04-13
08057760170018NuvolaGRUPPO EUROPEO DI ORTODONZIA SRLNXC2026-03-31
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