FDA.report

JS Dental Xtreme K-File

Primary DI
D8591K10106
Brand
JS Dental Xtreme K-File
Company
J. S. Dental Manufacturing, Inc.
Model
1K1010
Catalog number
1K1010
Device description
Xtreme K-File 21mm #10 (Package of 6). Endodontic root canal file made from heat treated nickel-titanium.
Published
2020-11-20
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

Contact Domains

Product Codes

CodeName
EKSFile, Pulp Canal, Endodontic

Product Code Classifications

CodeDeviceSpecialtyClass
EKSFile, Pulp Canal, EndodonticDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D8591K10106PrimaryHIBCC0
D8591K10101Unit of UseHIBCC0

GMDN Terms

TermDefinition
Manual endodontic file/rasp, reusableA hand-held manual dental instrument designed to debride and enlarge the root canal and smooth its walls by a cutting or abrasive action when moved in a longitudinal direction. It is made of metal [e.g., stainless steel, nickel-titanium alloy (Nitinol)] and its working end has a polygonal cross-section with edges. It may also be referred to as an endodontic reamer. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization;Dry Heat Sterilization

Contacts

PhoneEmail
1-203-438-8832info@jsdental.com

Regulatory Flags

DUNS number
101109114
Device count
6
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
true

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