FDA.reportPublic FDA data

StarDental Instrument Solutions

Primary DI
D7022024030
Brand
StarDental Instrument Solutions
Company
DENTALEZ, INC.
Model
202403
Device description
INSTR MG SE SPREADER D11T
Published
2018-11-05
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EKKSpreader, Pulp Canal Filling Material, Endodontic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EKKSpreader, Pulp Canal Filling Material, EndodonticDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D7022024030PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Manual endodontic filling material spreaderA hand-held, manually-operated dental instrument specifically designed to compress filling materials in a root canal, mainly in a lateral direction. The working part is tapered, circular in cross-section and has a pointed tip. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
1-866-383-4636xx@xx.xx

Regulatory Flags#

DUNS number
059010363
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D7022666500StarDental2666502666502026-04-22
D7022666510StarDental2666512666512026-04-22
D7022666520StarDental2666522666522026-04-22
D7022666530StarDental2666532666532026-04-22
D7022663420StarDental2663422663422025-06-20
D7022663430StarDental2663432025-06-20
D7022663450StarDental2663452025-06-20
D7022664900StarDental2664902025-06-20
D7022601520StarDental Instrument Solutions2601522018-11-05
D702RT3001050StarDental Instrument SolutionsRT3-001052016-09-13
D7022656330StarDental Instrument Solutions2656332018-11-05
D7022639480StarDental Instrument Solutions2639482018-11-05
D7022658060StarDental Instrument Solutions2658062018-11-05
D702RT3001130StarDental Instrument SolutionsRT3-001132016-09-12
D702RT3220000StarDental Instrument SolutionsRT3-220002016-09-12
D7022688600StarDental Instrument Solutions2688602018-11-05
D7022656300StarDental Instrument Solutions2656302018-11-05
D7022656340StarDental Instrument Solutions2656342018-11-05
D7022658210StarDental Instrument Solutions2658212018-11-05
D7022658220StarDental Instrument Solutions2658222018-11-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00348783009422Premier SpreaderPREMIER DENTAL PRODUCTS COMPANYEKK2026-05-06
00348783009439Premier SpreaderPREMIER DENTAL PRODUCTS COMPANYEKK2026-05-06
00348783009446Premier SpreaderPREMIER DENTAL PRODUCTS COMPANYEKK2026-05-06
00348783009460Premier SpreaderPREMIER DENTAL PRODUCTS COMPANYEKK2026-05-06
00348783009484Premier SpreaderPREMIER DENTAL PRODUCTS COMPANYEKK2026-05-06
00348783009507Premier SpreaderPREMIER DENTAL PRODUCTS COMPANYEKK2026-05-06
00348783009514Premier SpreaderPREMIER DENTAL PRODUCTS COMPANYEKK2026-05-06
00348783009521Premier SpreaderPREMIER DENTAL PRODUCTS COMPANYEKK2026-05-06
00348783009538Premier SpreaderPREMIER DENTAL PRODUCTS COMPANYEKK2026-05-06
00348783009477Premier SpreaderPREMIER DENTAL PRODUCTS COMPANYEKK2026-03-17
00348783009491Premier SpreaderPREMIER DENTAL PRODUCTS COMPANYEKK2026-03-17
00840456213513JMUJMU DENTAL, INCEKK2025-08-18
00889813066867Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEKK2025-03-12
00841013120435American Eagle Instruments, Inc.AMERICAN EAGLE INSTRUMENTS, INC.EKK2025-02-18
00841013120442American Eagle Instruments, Inc.AMERICAN EAGLE INSTRUMENTS, INC.EKK2025-02-18
00889813066843Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEKK2024-11-30
00889813066850Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEKK2024-11-30
00813677024480PDT, Inc.PDT, INC.EKK2024-06-27
00813677024985PDT, Inc.PDT, INC.EKK2024-06-27
08800075609809OSUNG MNDOSUNG MND Co., Ltd.EKK2024-03-04
08800075624048OSUNG MNDOSUNG MND Co., Ltd.EKK2024-03-04
06975718055359Denco Shenzhen Denco Medical Co., LtdEKK2023-12-27
06975718055366Denco Shenzhen Denco Medical Co., LtdEKK2023-12-27
06975718055373Denco Shenzhen Denco Medical Co., LtdEKK2023-12-27
06975718055380Denco Shenzhen Denco Medical Co., LtdEKK2023-12-27
D6919053814Premier SPREADERSPREMIER DENTAL PRODUCTS COMPANYEKK2023-10-17
D6919053816Premier SPREADERSPREMIER DENTAL PRODUCTS COMPANYEKK2023-10-17
D6919053818Premier SPREADERSPREMIER DENTAL PRODUCTS COMPANYEKK2023-10-17
D6919053820Premier SPREADERSPREMIER DENTAL PRODUCTS COMPANYEKK2023-10-17
D6919053826Premier SPREADERSPREMIER DENTAL PRODUCTS COMPANYEKK2023-10-17