FDA.reportPublic FDA data

Simple Line

Primary DI
08809162706391
Brand
Simple Line
Company
Dentium Co., Ltd.
Model
SOXHD21W
Catalog number
SOXHD21W
Device description
Driver, Band, Orthodontic
Published
2020-05-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
ECTDRIVER, BAND, ORTHODONTIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ECTDriver, Band, OrthodonticDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08809162706391PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809162706391088091627063918809162706391

GMDN Terms#

Term, Definition table
TermDefinition
Manual non-rotary dental instrument handleA hand-held, manual device designed to hold and facilitate manipulation of a non-powered, non-rotary dental instrument (e.g., endodontic file/rasp). It is designed to accept the patient-contact endpiece (not included) for ease of handling. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length21Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(714)226-0229cs@dentiumusa.com

Regulatory Flags#

DUNS number
689514395
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08809544909761Implantium, SuperlineWFFD3606WFFD36062026-05-15
08809544909778Implantium, SuperlineWFFD3608WFFD36082026-05-15
08809544909785Implantium, SuperlineWFFD3610WFFD36102026-05-15
08809544909792Implantium, SuperlineWFFD3612WFFD36122026-05-15
08809544909808Implantium, SuperlineWFFD4006WFFD40062026-05-15
08809544909815Implantium, SuperlineWFFD4008WFFD40082026-05-15
08809544909822Implantium, SuperlineWFFD4010WFFD40102026-05-15
08809544909839Implantium, SuperlineWFFD4012WFFD40122026-05-15
08809544909846Implantium, SuperlineWFFD4506WFFD45062026-05-15
08809544909853Implantium, SuperlineWFFD4508WFFD45082026-05-15
08809544909860Implantium, SuperlineWFFD4510WFFD45102026-05-15
08809544909877Implantium, SuperlineWFFD4512WFFD45122026-05-15
08809544909884Implantium, SuperlineWFFD5006WFFD50062026-05-15
08809544909891Implantium, SuperlineWFFD5008WFFD50082026-05-15
08809544909907Implantium, SuperlineWFFD5010WFFD50102026-05-15
08809544909914Implantium, SuperlineWFFD5012WFFD50122026-05-15
08809544909921Implantium, SuperlineWFTP35WFTP352026-05-15
08809544909938Implantium, SuperlineWFTP45WFTP452026-05-15
08809544909945Implantium, SuperlineWFFL35WFFL352026-05-15
08809544909952Implantium, SuperlineWFFL45WFFL452026-05-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08806145440129Orthodontic DriverDENTOS Inc.ECT2025-05-02
08806145440136Orthodontic DriverDENTOS Inc.ECT2025-05-02
08806145440143Orthodontic DriverDENTOS Inc.ECT2025-05-02
08806145440150Orthodontic DriverDENTOS Inc.ECT2025-05-02
08806145440167Orthodontic DriverDENTOS Inc.ECT2025-05-02
08806145440174Orthodontic DriverDENTOS Inc.ECT2025-05-02
08806145484086Orthodontic DriverDENTOS Inc.ECT2025-05-02
00371347018325Advance Dental ProductsThe Atlanta Dental Supply CompanyECT2025-01-02
08800041038121MalletSurgident Co.,Ltd.ECT2023-10-18
08800041039128Tac Remover DriverSurgident Co.,Ltd.ECT2023-10-18
08800041039135Tac ApplicatorSurgident Co.,Ltd.ECT2023-10-18
08800041039807Tac Remover DriverSurgident Co.,Ltd.ECT2023-10-18
08800041053469Tac ApplicatorSurgident Co.,Ltd.ECT2023-10-18
08800046045797SA-001GNI Co.,LtdECT2023-10-11
08800046045810SA-002GNI Co.,LtdECT2023-10-11
08800046045827SA-003GNI Co.,LtdECT2023-10-11
08800046045834SA-005GNI Co.,LtdECT2023-10-11
08800046045858SA-006GNI Co.,LtdECT2023-10-11
08800046045865SA-004GNI Co.,LtdECT2023-10-11
08800046045872SA-020GNI Co.,LtdECT2023-10-11
08800046045889SA-010GNI Co.,LtdECT2023-10-11
08800046046695SA-100GNI Co.,LtdECT2023-10-11
08800041052455Driver HandleSurgident Co.,Ltd.ECT2022-12-08
08800041052462Driver HandleSurgident Co.,Ltd.ECT2022-12-08
08809162705141Implantium, SuperlineDentium Co., Ltd.ECT2020-05-14
08809162705158Implantium, SuperlineDentium Co., Ltd.ECT2020-05-14
08809162705165Implantium, SuperlineDentium Co., Ltd.ECT2020-05-14
08809162705189Implantium, SuperlineDentium Co., Ltd.ECT2020-05-14
08809162705516Implantium, SuperlineDentium Co., Ltd.ECT2020-05-14
08809162705523Implantium, SuperlineDentium Co., Ltd.ECT2020-05-14