FDA.reportPublic FDA data

Dentapen Battery

Primary DI
EJUVBP047
Brand
Dentapen Battery
Company
JUVAPLUS SA
Model
Dentapen for Dentapen
Catalog number
BP04
Device description
Battery
Published
2018-10-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

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
EJUVBP048PackageHIBCC10In Commercial Distribution
EJUVBP047PrimaryHIBCC0
EJUVBP04Unit of UseHIBCC0

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

Contacts#

Phone, Email table
PhoneEmail
+41329302979info@juvaplus.com

Regulatory Flags#

DUNS number
486026102
Device count
3
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
EJUVPS021Dentapen Protective SleeveDentapen Protective SleevePS022019-09-30
EJUVPS011Dentapen Protective SleeveDentapen Protective SleevePS012019-01-30
EJUVDP057Dentapen Cartridge holderCartridge hodler for DentapenDP052018-10-22
EJUVDENTAPENINJECTOR1Dentapen InjectorDentapen Dentapen Injector2018-10-22
EJUVDK01SEPTODONTUS1Complete Dentapen KitDentapen kit 01DK01 SEPTODONT US2018-10-22
EJUVDP027Dentapen Finger GripFinger Grip for Dentapen DP022018-10-22
EJUVDP047Dentapen Finger Grip for Nerve BlockFinger Grip for Nerve Block for DentapenDP042018-10-22
EJUVDP058Dentapen Cartridge holderCartridge hodler for DentapenDP052018-10-22

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
08800053042093DENOPSDENTIS CO. ,LTDEJI2024-01-23
00840326421765AstekYoung Innovations, Inc.EJI2023-12-01
00840326421772AstekYoung Innovations, Inc.EJI2023-12-01