FDA.reportPublic FDA data

IES1-1001

Primary DI
08800046027540
Brand
IES1-1001
Company
GNI Co.,Ltd
Model
IES1-1001
Published
2024-06-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
DYJRetainer, Screw Expansion, Orthodontic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DYJRetainer, Screw Expansion, OrthodonticDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800046027540PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800046027540088000460275408800046027540

GMDN Terms#

Term, Definition table
TermDefinition
Orthodontic retainerAn orthodontic appliance, bonded or removable, intended to be used on a single patient to maintain teeth in corrected positions during the period of functional adaptation following corrective treatment. This appliance, also referred to as a positioner, is also used to maintain the positions of the teeth and jaws gained by orthodontic procedures.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
694828541
Device count
1
Kit
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800046051484SS650SS6502025-04-04
08800046051309SSBC-M22-464GSSBC-M22-464G2024-06-18
08800046051316SSBC-M22-364GSSBC-M22-364G2024-06-18
08800046051323SSBC-M22-264GSSBC-M22-264G2024-06-18
08800046051330SSBC-M22-164GSSBC-M22-164G2024-06-18
08800046051385SSBC-M22-1M44GSSBC-M22-1M44G2024-06-18
08800046045896P01-01P01-012024-06-04
08800046046602SN02-1018SN02-10182024-06-04
08800046050357ELT-01ELT-012024-06-04
08800046000642SA1208CSA1208C2022-12-13
08800046000659SA1210CSA1210C2022-12-13
08800046000666SA1406CSA1406C2022-12-13
08800046000673SA1408CSA1408C2022-12-13
08800046000680SA1410CSA1410C2022-12-13
08800046000697SA1606CSA1606C2022-12-13
08800046000703SA1608CSA1608C2022-12-13
08800046000710SA1610CSA1610C2022-12-13
08800046000727SA1806CSA1806C2022-12-13
08800046000734SA1808CSA1808C2022-12-13
08800046000741SA1810CSA1810C2022-12-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08033707104513LEONE SPALEONE SPADYJ2026-05-28
00840456221761JMUJMU DENTAL, INCDYJ2026-05-11
00840456221778JMUJMU DENTAL, INCDYJ2026-05-11
D775AHAD0Hawley Retainer with Adams ClaspsGreat Lakes Dental Technologies, Ltd.DYJ2026-05-10
D775AHAR0Hawley Retainer with Arrow ClaspsGreat Lakes Dental Technologies, Ltd.DYJ2026-05-10
D775AHBC0Hawley Retainer with Ball ClaspsGreat Lakes Dental Technologies, Ltd.DYJ2026-05-10
D775AHCC0Hawley Retainer with Circumferential ClaspsGreat Lakes Dental Technologies, Ltd.DYJ2026-05-10
D775BMARPEL0MARPEGreat Lakes Dental Technologies, Ltd.DYJ2026-05-10
D775BMARPEP0MARPEGreat Lakes Dental Technologies, Ltd.DYJ2026-05-10
D775BMMT0MemotainGreat Lakes Dental Technologies, Ltd.DYJ2026-05-10
00197998216633Clarity™Solventum Orthodontics CorporationDYJ2026-04-25
10371347023326Advance Dental ProductsThe Atlanta Dental Supply CompanyDYJ2026-04-14
10371347023333Advance Dental ProductsThe Atlanta Dental Supply CompanyDYJ2026-04-14
10371347023340Advance Dental ProductsThe Atlanta Dental Supply CompanyDYJ2026-04-14
10371347023357Advance Dental ProductsThe Atlanta Dental Supply CompanyDYJ2026-04-14
D775AEA0Expansion ApplianceGreat Lakes Dental Technologies, Ltd.DYJ2026-04-13
D775AH0Hawley RetainerGreat Lakes Dental Technologies, Ltd.DYJ2026-04-13
D775BKS0Keles SliderGreat Lakes Dental Technologies, Ltd.DYJ2026-04-13
00190746202766PowerScopeAMERICAN ORTHODONTICS CORPORATIONDYJ2026-04-08
08033707104827LEONE SPALEONE SPADYJ2026-04-01
08033707104834LEONE SPALEONE SPADYJ2026-04-01
08800197901621ATOZ KeyMK Meditech Inc.DYJ2025-11-03
J011430120310prime4me®DENTAURUM GmbH & Co.KGDYJ2025-10-09
J011430120410prime4me®DENTAURUM GmbH & Co.KGDYJ2025-10-09
07895742296612MorelliDental Morelli LtdaDYJ2025-09-10
07895742296629MorelliDental Morelli LtdaDYJ2025-09-10
07895742296636MorelliDental Morelli LtdaDYJ2025-09-10
07895742296643MorelliDental Morelli LtdaDYJ2025-09-10
J011430120400prime4me®DENTAURUM GmbH & Co.KGDYJ2025-07-10
J01854551HerbstScheu-Dental GmbHDYJ2024-11-19