K FILES 20102001

GUDID J015201020011

Endodontic instruments for professionnal use only

MICRO MEGA

Manual endodontic file/rasp, reusable Manual endodontic file/rasp, reusable Manual endodontic file/rasp, reusable Manual endodontic file/rasp, reusable Manual endodontic file/rasp, reusable Manual endodontic file/rasp, reusable Manual endodontic file/rasp, reusable Manual endodontic file/rasp, reusable Manual endodontic file/rasp, reusable Manual endodontic file/rasp, reusable Manual endodontic file/rasp, reusable Manual endodontic file/rasp, reusable Manual endodontic file/rasp, reusable Manual endodontic file/rasp, reusable

• Primary Device ID: J015201020011
• NIH Device Record Key: 90ad7f6d-ae3c-4bff-828c-7e5e3a102a12
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: K FILES
• Version Model Number: n006 L21 ISO M09
• Catalog Number: 20102001
• Company DUNS: 276075371
• Company Name: MICRO MEGA
• Device Count: 6
• DM Exempt: true
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	J015201020010 [Unit of Use]
HIBCC	J015201020011 [Primary]
HIBCC	J015201020012 [Package]; Package: Grouping box [10 Units]; In Commercial Distribution

FDA Product Code

• EKS: File, Pulp Canal, Endodontic

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[J015201020011]

Moist Heat or Steam Sterilization

[J015201020011]

Moist Heat or Steam Sterilization

[J015201020011]

Moist Heat or Steam Sterilization

[J015201020011]

Moist Heat or Steam Sterilization

[J015201020011]

Moist Heat or Steam Sterilization

[J015201020011]

Moist Heat or Steam Sterilization

[J015201020011]

Moist Heat or Steam Sterilization

[J015201020011]

Moist Heat or Steam Sterilization

[J015201020011]

Moist Heat or Steam Sterilization

[J015201020011]

Moist Heat or Steam Sterilization

[J015201020011]

Moist Heat or Steam Sterilization

[J015201020011]

Moist Heat or Steam Sterilization

[J015201020011]

Moist Heat or Steam Sterilization

[J015201020011]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-07-31
• Device Publish Date: 2020-07-23

On-Brand Devices [K FILES]

• J015201020011: Endodontic instruments for professionnal use only
• J015201020269: Endodontic instruments for professionnal use only
• J015201020179: Endodontic instruments for professionnal use only
• J015201020149: Endodontic instruments for professionnal use only
• J015201020139: Endodontic instruments for professionnal use only
• J015201020119: Endodontic instruments for professionnal use only
• J015201020109: Endodontic instruments for professionnal use only
• J015201020089: Endodontic instruments for professionnal use only
• J015201020079: Endodontic instruments for professionnal use only
• J015201020059: Endodontic instruments for professionnal use only
• J015201020049: Endodontic instruments for professionnal use only
• J015201020029: Endodontic instrument for professionnal dental use only