FDA.reportPublic FDA data

GPRO

Primary DI
00837699001021
Brand
GPRO
Company
Beyes Dental Canada Inc
Model
GP2003
Device description
GPRO P1,Gutta-percha Obturation Heating Pen Tips included: 40mm/04 taper, 45mm/04 taper, 55mm/06 taper, 55mm/08 taper
Published
2022-10-06
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
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
00837699001021PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00837699001021008376990010218376990010210837699001021

GMDN Terms#

Term, Definition table
TermDefinition
Endodontic obturation system handpiece, heat conductingA handpiece, which is part of an endodontic obturation system, intended to control through its hand-switch an electrical current from the generator to the tip of an attached dental instrument where it is converted to resistive heat used to test tooth response to thermal stimulus during treatment involving root canal obturation procedures. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
244261462
Device count
1
Premarket exempt
true
Serial number
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00990010312418DURAY2D2025-12-15
00990010312562DURAY3D2025-12-15
00990010312579DURAYART PLUS2025-12-15
00990010312586DURAY2D CEPH2025-12-15
00990010312593DURAY3D CEPH2025-12-15
00990010312609DURAYART PLUS C2025-12-15
00990010301290DURAYDC1001DC12023-05-11
00837699000109DURAYDC10012022-10-06
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08404535018981Brasseler USAPeter Brasseler Holdings, LLCEKR2026-06-26
00348783009002Premier PluggersPREMIER DENTAL PRODUCTS COMPANYEKR2026-04-30
00348783009019Premier PluggersPREMIER DENTAL PRODUCTS COMPANYEKR2026-04-30
00348783009026Premier PluggersPREMIER DENTAL PRODUCTS COMPANYEKR2026-04-30
00348783009033Premier PluggersPREMIER DENTAL PRODUCTS COMPANYEKR2026-04-30
00348783009057Premier PluggersPREMIER DENTAL PRODUCTS COMPANYEKR2026-04-30
00348783008975Premier PluggersPREMIER DENTAL PRODUCTS COMPANYEKR2026-04-29
00348783008982Premier PluggersPREMIER DENTAL PRODUCTS COMPANYEKR2026-04-29
00348783008999Premier PluggersPREMIER DENTAL PRODUCTS COMPANYEKR2026-04-29
00348783009125Premier PluggersPREMIER DENTAL PRODUCTS COMPANYEKR2026-04-29
00348783009132Premier PluggersPREMIER DENTAL PRODUCTS COMPANYEKR2026-04-29
00348783009149Premier PluggersPREMIER DENTAL PRODUCTS COMPANYEKR2026-04-29
00348783008913Premier PluggersPREMIER DENTAL PRODUCTS COMPANYEKR2026-04-28
00348783008920Premier PluggersPREMIER DENTAL PRODUCTS COMPANYEKR2026-04-28
00348783008937Premier PluggersPREMIER DENTAL PRODUCTS COMPANYEKR2026-04-28
00348783008944Premier PluggersPREMIER DENTAL PRODUCTS COMPANYEKR2026-04-28
00348783008951Premier PluggersPREMIER DENTAL PRODUCTS COMPANYEKR2026-04-28
00348783009088Premier PluggersPREMIER DENTAL PRODUCTS COMPANYEKR2026-04-28
00348783009095Premier PluggersPREMIER DENTAL PRODUCTS COMPANYEKR2026-04-28
00348783009101Premier PluggersPREMIER DENTAL PRODUCTS COMPANYEKR2026-04-28
00348783009118Premier PluggersPREMIER DENTAL PRODUCTS COMPANYEKR2026-04-28
E89616970207E0SCHWERTA. Schweickhardt GmbH & Co. KGEKR2025-10-14
E89616970307E0SCHWERTA. Schweickhardt GmbH & Co. KGEKR2025-10-14
E89616970TI07E0SCHWERTA. Schweickhardt GmbH & Co. KGEKR2025-10-14
E896169701TI07E0SCHWERTA. Schweickhardt GmbH & Co. KGEKR2025-07-16
E8961697020TI0SCHWERTA. Schweickhardt GmbH & Co. KGEKR2025-06-24
00813677024480PDT, Inc.PDT, INC.EKR2024-06-27
00813677024985PDT, Inc.PDT, INC.EKR2024-06-27
00843471100288Obtura SpartanYoung Innovations, Inc.EKR2024-01-15
00843471100301Obtura SpartanYoung Innovations, Inc.EKR2024-01-15