FDA.reportPublic FDA data

EVOFILL DUO

Primary DI
08806383554855
Brand
EVOFILL DUO
Company
DiaDent Group International
Model
DUAL CHARGER
Catalog number
4005-2020
Device description
EvoFill Duo(Gutta percha obturation System) is an electrically powered dental device used for heating Gutta percha and placing the softened material in prepared root canals of teeth during root canal therapy.
Published
2020-05-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
EKRPlugger, Root Canal, Endodontic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EKRPlugger, Root Canal, EndodonticDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08806383554855PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08806383554855088063835548558806383554855

GMDN Terms#

Term, Definition table
TermDefinition
Endodontic obturation systemAn assembly of devices intended to be used during endodontic treatment involving root canal obturation procedures. It may be used in a variety of modes, e.g., to provide continuous heat to the tip of a dental instrument to test tooth response to thermal stimulus, for tissue cauterization and coagulation, and to backfill and down pack gutta-percha during endodontic root canal treatment or root canal obturation. It typically consists of a mains electricity (AC-powered) generator that regulates an electrical current used to produce resistive heat via the handpieces for the application of the heat, or extrude gutta-percha during a root canal obturation.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity30 Percent (%) Relative Humidity85 Percent (%) Relative Humidity
Storage Environment Temperature0 Degrees Celsius40 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
687789453
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
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
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06944835131147DIA-X FILE21mm D1/D4 Asst571-S1912026-02-20
06944835131154DIA-X FILE25mm D1/D4 Asst571-S2912026-02-20
06944835131338DIA-X FILE19mm/21mm DX/D3 Asst571-S1922026-02-20
06944835131345DIA-X FILE19mm/25mm DX/D3 Asst 571-S2912026-02-20
06944835173291DIA-X FILE19mm DX571-S1002026-02-20
06944835173307DIA-X FILE21mm D1 571-S1012026-02-20
06944835173314DIA-X FILE21mm D2 571-S1022026-02-20
06944835173321DIA-X FILE21mm D3571-S1032026-02-20
06944835173338DIA-X FILE21mm D4571-S1042026-02-20
06944835173345DIA-X FILE21mm D5 571-S1052026-02-20
06944835173369DIA-X FILE21mm D6571-S1062026-02-20
06944835173376DIA-X FILE21mm D7 571-S1072026-02-20
06944835173383DIA-X FILE25mm D1571-S2012026-02-20
06944835173390DIA-X FILE25mm D2571-S2022026-02-20
06944835173406DIA-X FILE25mm D3571-S2032026-02-20
06944835173413DIA-X FILE25mm D4571-S2042026-02-20
06944835173420DIA-X FILE25mm D5571-S2052026-02-20
06944835173444DIA-X FILE25mm D6571-S2062026-02-20
06944835173451DIA-X FILE25mm D7571-S2072026-02-20
08806383564687Diapex PlusType AA1001-5012019-08-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08404535019247Brasseler USAPeter Brasseler Holdings, LLCEKR2026-03-24
00348783008968Premier PluggersPREMIER DENTAL PRODUCTS COMPANYEKR2026-03-17
00348783009040Premier PluggersPREMIER DENTAL PRODUCTS COMPANYEKR2026-03-17
00348783009064Premier PluggersPREMIER DENTAL PRODUCTS COMPANYEKR2026-03-17
00348783009071Premier PluggersPREMIER DENTAL PRODUCTS COMPANYEKR2026-03-17
00840018667525Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEKR2026-02-10
06941877827816ZarcChangzhou Sifary Medical Technology Co., Ltd.EKR2026-01-05
06941877827823ZarcChangzhou Sifary Medical Technology Co., Ltd.EKR2026-01-05
E896169520SCHWERTA. Schweickhardt GmbH & Co. KGEKR2025-05-19
E896169710007E0SCHWERTA. Schweickhardt GmbH & Co. KGEKR2025-04-07
E89616971TI06E0SCHWERTA. Schweickhardt GmbH & Co. KGEKR2025-04-07
08806383586313DUO-GUNDiaDent Group InternationalEKR2025-03-12
08806383586320DUO-PENDiaDent Group InternationalEKR2025-03-12
06944843619071EDEGENDOGuilin Woodpecker Medical Instrument Co., Ltd.EKR2025-03-11
06944843619088EDEGENDOGuilin Woodpecker Medical Instrument Co., Ltd.EKR2025-03-11
06970873260389Integrated Endo SystemDENJOY DENTAL CO.,LTDEKR2025-02-28
04260482991166EndoPilot D-Pack² handpieceSchlumbohm GmbH & Co. KGEKR2025-01-28
04260482991173EndoPilot² expansion DownPack²Schlumbohm GmbH & Co. KGEKR2025-01-28
08809455602164elements IC META SYSTEMS CO., LTD.EKR2024-12-30
08809455602171elements ICMETA SYSTEMS CO., LTD.EKR2024-12-30
08809455602188elements ICMETA SYSTEMS CO., LTD.EKR2024-12-30
08809455602195elements ICMETA SYSTEMS CO., LTD.EKR2024-12-30
08809455602386elements ICMETA SYSTEMS CO., LTD.EKR2024-12-30
08809455602393elements ICMETA SYSTEMS CO., LTD.EKR2024-12-30
08809455602409elements ICMETA SYSTEMS CO., LTD.EKR2024-12-30
00889813066836Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEKR2024-12-12
08800019101581NeedleB& L Biotech, inc.EKR2024-12-03
08800019102168NeedleB& L Biotech, inc.EKR2024-12-03
08800019102175NeedleB& L Biotech, inc.EKR2024-12-03
08800019102182NeedleB& L Biotech, inc.EKR2024-12-03