FDA.report

EdgePack™

Primary DI
00818365028443
Brand
EdgePack™
Company
US ENDODONTICS, LLC
Model
EEDPUT6012
Catalog number
EEDPUT6012
Device description
EdgePack WP6012 Tip
Published
2023-06-25
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

Related Records

Product Codes

CodeName
EKRPLUGGER, ROOT CANAL, ENDODONTIC

Product Code Classifications

CodeDeviceSpecialtyClass
EKRPlugger, Root Canal, EndodonticDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00818365028443PrimaryGS10

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

Contacts

PhoneEmail
+1(423)283-0047Bobby.bennett@us-endo.com

Regulatory Flags

DUNS number
061317427
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
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
false

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10810047645518EdgeSequel UtopiaES250625SEES250625SE2023-07-28
10810047645525EdgeSequel UtopiaES250631SEES250631SE2023-07-28
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