Premier K-FILES

GUDID D6919053240

FILES PKG 6 25MM 50

PREMIER DENTAL PRODUCTS COMPANY

Manual endodontic file/rasp, reusable

• Primary Device ID: D6919053240
• NIH Device Record Key: cc2f46ed-99c5-49dd-a0a9-e0dbc009e11d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Premier K-FILES
• Version Model Number: 9053240
• Company DUNS: 014789663
• Company Name: PREMIER DENTAL PRODUCTS COMPANY
• Device Count: 1
• 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: false
• 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	D6919053240 [Primary]

FDA Product Code

• EKS: File, Pulp Canal, Endodontic

Sterilization

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

[D6919053240]

Moist Heat or Steam Sterilization

[D6919053240]

Moist Heat or Steam Sterilization

[D6919053240]

Moist Heat or Steam Sterilization

[D6919053240]

Moist Heat or Steam Sterilization

[D6919053240]

Moist Heat or Steam Sterilization

[D6919053240]

Moist Heat or Steam Sterilization

[D6919053240]

Moist Heat or Steam Sterilization

[D6919053240]

Moist Heat or Steam Sterilization

[D6919053240]

Moist Heat or Steam Sterilization

[D6919053240]

Moist Heat or Steam Sterilization

[D6919053240]

Moist Heat or Steam Sterilization

[D6919053240]

Moist Heat or Steam Sterilization

[D6919053240]

Moist Heat or Steam Sterilization

[D6919053240]

Moist Heat or Steam Sterilization

[D6919053240]

Moist Heat or Steam Sterilization

[D6919053240]

Moist Heat or Steam Sterilization

[D6919053240]

Moist Heat or Steam Sterilization

[D6919053240]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-10-25
• Device Publish Date: 2023-10-17

On-Brand Devices [Premier K-FILES]

• D6919053312: FILES PKG 6 31MM 45-80
• D6919053311: FILES PKG 6 31MM 15-40
• D6919053304: FILES PKG 6 31MM 80
• D6919053303: FILES PKG 6 31MM 70
• D6919053302: FILES PKG 6 31MM 60
• D6919053301: FILES PKG 6 31MM 55
• D6919053300: FILES PKG 6 31MM 50
• D6919053299: FILES PKG 6 31MM 45
• D6919053298: FILES PKG 6 31MM 40
• D6919053297: FILES PKG 6 31MM 35
• D6919053296: FILES PKG 6 31MM 30
• D6919053295: FILES PKG 6 31MM 25
• D6919053294: FILES PKG 6 31MM 20
• D6919053293: FILES PKG 6 31MM 15
• D6919053292: FILES PKG 6 31MM 10
• D6919053291: FILES PKG 6 31MM 08
• D6919053290: FILES PKG 6 31MM 06
• D6919053249: FILES PKG 6 25MM 45-80
• D6919053248: FILES PKG 6 25MM 15-40
• D6919053244: FILES PKG 6 25MM 80
• D6919053243: FILES PKG 6 25MM 70
• D6919053242: FILES PKG 6 25MM 60
• D6919053241: FILES PKG 6 25MM 55
• D6919053240: FILES PKG 6 25MM 50
• D6919053239: FILES PKG 6 25MM 45
• D6919053238: FILES PKG 6 25MM 40
• D6919053237: FILES PKG 6 25MM 35
• D6919053236: FILES PKG 6 25MM 30
• D6919053235: FILES PKG 6 25MM 25
• D6919053234: FILES PKG 6 25MM 20
• D6919053233: FILES PKG 6 25MM 15
• D6919053232: FILES PKG 6 25MM 10
• D6919053231: FILES PKG 6 25MM 08
• D6919053230: FILES PKG 6 25MM 06
• D6919053219: FILES PKG 6 21MM 45-80
• D6919053218: FILES PKG 6 21MM 15-40
• D6919053212: FILES PKG 6 21MM 60
• D6919053211: FILES PKG 6 21MM 55
• D6919053210: FILES PKG 6 21MM 50
• D6919053209: FILES PKG 6 21MM 45
• D6919053208: FILES PKG 6 21MM 40
• D6919053207: FILES PKG 6 21MM 35
• D6919053206: FILES PKG 6 21MM 30
• D6919053205: FILES PKG 6 21MM 25
• D6919053204: FILES PKG 6 21MM 20
• D6919053203: FILES PKG 6 21MM 15
• D6919053202: FILES PKG 6 21MM 10
• D6919053201: FILES PKG 6 21MM 08
• D6919053200: FILES PKG 6 21MM 06