FDA.reportPublic FDA data

DENOPS

Primary DI
08800053042093
Brand
DENOPS
Company
DENTIS CO. ,LTD
Model
AN100
Device description
DC : 3.7 V, 550mh(Battery)
Published
2024-01-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
EJISyringe, Cartridge

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EJISyringe, CartridgeDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800053042093PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800053042093088000530420938800053042093

GMDN Terms#

Term, Definition table
TermDefinition
Dental anaesthesia syringe, reusableA hand-held manual dental instrument consisting of a barrel (cylinder) with plunger/piston intended to be used for injecting an anaesthetic agent, subcutaneously or intramuscularly, from a prefilled, single-use cartridge through an attached sterile needle; a needle is not included. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
694721181
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800313235715SQ AXEL Guide CountersinkDSAGCS502026-07-09
08800313235722SQ AXEL Guide CountersinkDSAGCS462026-07-09
08800313235739SQ AXEL Guide CountersinkDSAGCS422026-07-09
08800313235746SQ AXEL Guide CountersinkDSAGCS382026-07-09
08800313235753SQ AXEL Guide Step DrillDSAGSTD50162026-07-09
08800313235760SQ AXEL Guide Step DrillDSAGSTD50142026-07-09
08800313235777SQ AXEL Guide Step DrillDSAGSTD50122026-07-09
08800313235784SQ AXEL Guide Step DrillDSAGSTD50102026-07-09
08800313235791SQ AXEL Guide Step DrillDSAGSTD50082026-07-09
08800313235807SQ AXEL Guide Step DrillDSAGSTD46162026-07-09
08800313235814SQ AXEL Guide Step DrillDSAGSTD46142026-07-09
08800313235821SQ AXEL Guide Step DrillDSAGSTD46122026-07-09
08800313235838SQ AXEL Guide Step DrillDSAGSTD46102026-07-09
08800313235845SQ AXEL Guide Step DrillDSAGSTD46082026-07-09
08800313235852SQ AXEL Guide Step DrillDSAGSTD42162026-07-09
08800313235869SQ AXEL Guide Step DrillDSAGSTD42142026-07-09
08800313235876SQ AXEL Guide Step DrillDSAGSTD42122026-07-09
08800313235883SQ AXEL Guide Step DrillDSAGSTD42102026-07-09
08800313235890SQ AXEL Guide Step DrillDSAGSTD42082026-07-09
08800313235906SQ AXEL Guide Step DrillDSAGSTD38162026-07-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03760349801054QUICKSLEEPER 5C_A2 US/CADENTALHITECEJI2025-12-22
00840326422670AstekYoung Innovations, Inc.EJI2025-10-10
00840326423691AstekYoung Innovations, Inc.EJI2025-10-10
00840326422687AstekYoung Innovations, Inc.EJI2025-05-27
00840326423707AstekYoung Innovations, Inc.EJI2025-05-27
00840326422663AstekYoung Innovations, Inc.EJI2025-05-27
00840326423684AstekYoung Innovations, Inc.EJI2025-05-27
00840326423721AstekYoung Innovations, Inc.EJI2025-05-27
05713513001185ASPIJECT Active CompactRønvig Dental Manufacturing A/SEJI2025-02-27
05060212052117Dental Syringe 85mm, for 2.2ml vialDTR MEDICAL LIMITEDEJI2024-10-11
05060212052124Dental Syringe Long 115mm, for 2.2ml vialDTR MEDICAL LIMITEDEJI2024-10-11
05060212057518Dental Syringe 85mm, for 2.2ml vialDTR MEDICAL LIMITEDEJI2024-10-11
05060212057525Dental Syringe Long 115mm, for 2.2ml vialDTR MEDICAL LIMITEDEJI2024-10-11
00813677022882PDT, Inc.PDT, INC.EJI2024-07-01
00813677022905PDT, Inc.PDT, INC.EJI2024-07-01
00813677022899PDT, Inc.PDT, INC.EJI2024-06-27
08800075607799OSUNG MNDOSUNG MND Co., Ltd.EJI2024-03-05
08800075614391OSUNG MNDOSUNG MND Co., Ltd.EJI2024-03-05
08800075614407OSUNG MNDOSUNG MND Co., Ltd.EJI2024-03-05
08800075614421OSUNG MNDOSUNG MND Co., Ltd.EJI2024-03-05
08800075624994OSUNG MNDOSUNG MND Co., Ltd.EJI2024-03-05
08800075607812OSUNG MNDOSUNG MND Co., Ltd.EJI2024-02-23
08800075626332OSUNG MNDOSUNG MND Co., Ltd.EJI2024-02-23
08800075626349OSUNG MNDOSUNG MND Co., Ltd.EJI2024-02-23
08800075626356OSUNG MNDOSUNG MND Co., Ltd.EJI2024-02-23
08800075614360OSUNG MNDOSUNG MND Co., Ltd.EJI2024-02-22
08800075614414OSUNG MNDOSUNG MND Co., Ltd.EJI2024-02-22
00840326421765AstekYoung Innovations, Inc.EJI2023-12-01
00840326421772AstekYoung Innovations, Inc.EJI2023-12-01
00840326421789AstekYoung Innovations, Inc.EJI2023-12-01