FDA.reportPublic FDA data

BI-DIMENSIONAL

Primary DI
D80703000021
Brand
BI-DIMENSIONAL
Company
DENTSPLY SIRONA ORTHODONTICS INC.
Model
03-000-02
Catalog number
03-000-02
Device description
BI-DIMENSIONAL® UPRIGHT SPG LEFT PK10
Published
2020-09-24
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
D80703000021PrimaryHIBCC0
D80703000020Unit of UseHIBCC0

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.

Contacts#

Phone, Email table
PhoneEmail
+1(833)372-8255CustomerService_GAC@dentsplysirona.com

Regulatory Flags#

DUNS number
116903307
Device count
10
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
D746EPOO4W1PonticEPOO4-WEPOO4-W2016-09-24
D746EPOO4Y1PonticEPOO4-YEPOO4-Y2016-09-24
D746RBTPC1RETAINER BRITE®RB-TP-CRB-TP-C2021-05-01
D746ELA6G1Lower Anterior PonticELA6-GELA6-G2016-09-24
D746ELA6W1Lower Anterior PonticELA6-WELA6-W2016-09-24
D746ELA6Y1Lower Anterior PonticELA6-YELA6-Y2016-09-24
D746EUT6W1Essix®EUT6-WEUT6-W2016-09-24
D746EUT6Y1Essix®EUT6-YEUT6-Y2016-09-24
D746PLMOG1Posterior Lower PonticPLMO-GPLMO-G2016-09-24
D746PLMOW1Posterior Lower PonticPLMO-WPLMO-W2016-09-24
D746PLMOY1Posterior Lower PonticPLMO-YPLMO-Y2016-09-24
D746PUMOG1Posterior Lower PonticPUMO-GPUMO-G2016-09-24
D746PUMOW1Posterior Lower PonticPUMO-WPUMO-W2016-09-24
D746PUMOY1Posterior Lower PonticPUMO-YPUMO-Y2016-09-24
D746SUA6W1Square Upper PonticSUA6-WSUA6-W2016-09-24
D746SUA6Y1Square Upper PonticSUA6-YSUA6-Y2016-09-24
D746TUA6G1EssixTUA6-GTUA6-G2016-09-24
D746TUA6W1EssixTUA6-WTUA6-W2016-09-24
D746TUA6Y1EssixTUA6-YTUA6-Y2016-09-24
D74640035BL1SpaceFile®40035-BL40035-BL2021-12-16

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