FDA.report

EndoPilot

Primary DI
00990010301344
Brand
EndoPilot
Company
Beyes Dental Canada Inc
Model
AL2030
Catalog number
EndoPilot
Device description
EndoPilot, Cordless Endodontic Handpiece
Published
2023-05-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
EKRPlugger, Root Canal, Endodontic

Product Code Classifications

CodeDeviceSpecialtyClass
EKRPlugger, Root Canal, EndodonticDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00990010301344PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00990010301344009900103013449900103013440990010301344

GMDN Terms

TermDefinition
Endodontic apex locatorA dental instrument, using electricity, designed to locate the top of the root canal during endodontic procedures. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
244261462
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
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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00990010312562DURAY3D2025-12-15
00990010312579DURAYART PLUS2025-12-15
00990010312586DURAY2D CEPH2025-12-15
00990010312593DURAY3D CEPH2025-12-15
00990010312609DURAYART PLUS C2025-12-15
00990010306653Comfort-Sonic UL2214K-92024-01-19
00990010306660Comfort-Sonic UL2215K-102024-01-19
00990010306677Comfort-Sonic UL2216K-112024-01-19
00990010306684Comfort-Sonic UL2217K-602024-01-19
00990010306691Comfort-Sonic UL2218K-612024-01-19
00990010306707Comfort-Sonic UL2219K-622024-01-19
00990010306714Comfort-Sonic UL2220K-A112024-01-19
00990010306721Comfort-Sonic UL2221K-E82024-01-19
00990010306738Comfort-Sonic UL2222K-512024-01-19
00990010306462Beyes849961FG 582023-12-28
00990010306479Beyes889904FG 58L2023-12-28
00990010306486Beyes889905FG SS 5592023-12-28
00990010306493Beyes889906FG 559L2023-12-28
00990010306509Beyes850251FG SS 15582023-12-28

Other Devices Sharing Product Codes

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