FDA.reportPublic FDA data

Ormco

Primary DI
10889989031253
Brand
Ormco
Company
ORMCO CORPORATION
Model
221-5512
Device description
COMPRESSION SPRING NITI 012X030 PK3
Published
2022-12-06
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

Contact Domains#

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
00889989031256PrimaryGS10
10889989031253Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889989031256008899890312568899890312560889989031256
1088998903125310889989031253

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+18008541741ormcocustcare@ormco.com

Regulatory Flags#

DUNS number
154614119
Device count
3
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
false
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
00889989079494Tevdek II975-00502016-09-08
00889989079500Tevdek II975-00522016-09-08
00889989079517Tevdek II975-00542016-09-08
00889989079524Tevdek II975-00562016-09-08
00889989079531Tevdek II975-00632016-09-12
00889989079548Tevdek II975-00652016-09-12
00889989079555Tevdek II975-00672016-09-12
00889989073140Tubli-Seal003402016-09-08
00889989073157Tubli-Seal010812016-09-08
00889989074116Sealapex184322016-09-08
00889989074123Sealapex185982016-09-08
00889989074130Pulp Canal Sealer EWT247452016-09-08
00889989074147Pulp Canal Sealer EWT247462016-09-08
00889989074154Pulp Canal Sealer248732016-09-08
00889989074161Pulp Canal Sealer248742016-09-08
00889989074178Pulp Canal Sealer248752016-09-08
00889989074192Tubli-Seal EWT259032016-09-08
00889989074215Sealapex Xpress336392016-09-08
00889989074222Tubli-Seal Xpress336402016-09-08
00889989074239Tubli-Seal EWT Xpress336412016-09-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07895742274726MorelliDental Morelli LtdaECO2026-06-02
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