FDA.report

GPRO

Primary DI
00990010302211
Brand
GPRO
Company
Beyes Dental Canada Inc
Model
GP2003
Catalog number
GPRO P1
Device description
GPRO P1,Gutta-percha Obturation Heating Pen Tips included: 40mm/04 taper, 45mm/04 taper, 55mm/06 taper, 55mm/08 taper
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
00990010302211PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00990010302211009900103022119900103022110990010302211

GMDN Terms

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
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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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

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