FDA.report

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
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
EKKSpreader, Pulp Canal Filling Material, Endodontic

Product Code Classifications

CodeDeviceSpecialtyClass
EKKSpreader, Pulp Canal Filling Material, EndodonticDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D7022024030PrimaryHIBCC0

GMDN Terms

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
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
1-866-383-4636xx@xx.xx

Regulatory Flags

DUNS number
059010363
Device count
1
DM exempt
true
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
true

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D7022625830StarDental Instrument Solutions2625832018-11-05
D7022639720StarDental Instrument Solutions2639722018-11-05

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
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
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
D6919053830Premier SPREADERSPREMIER DENTAL PRODUCTS COMPANYEKK2023-10-17
D6919053832Premier SPREADERSPREMIER DENTAL PRODUCTS COMPANYEKK2023-10-17
D6919053834Premier SPREADERSPREMIER DENTAL PRODUCTS COMPANYEKK2023-10-17
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D6919053842Premier SPREADERSPREMIER DENTAL PRODUCTS COMPANYEKK2023-10-17
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E226006825A38KOMET SpreaderGebr. Brasseler GmbH & Co. KGEKK2023-08-25
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E226006827A38KOMET SpreaderGebr. Brasseler GmbH & Co. KGEKK2023-08-25
E226006828A38KOMET SpreaderGebr. Brasseler GmbH & Co. KGEKK2023-08-25
E226006829A38KOMET SpreaderGebr. Brasseler GmbH & Co. KGEKK2023-08-25