Thermafil SVK640

GUDID D716SVK6401

Verifier: PL 6pk 40/25mm

TULSA DENTAL PRODUCTS LLC

Manual endodontic file/rasp, reusable

• Primary Device ID: D716SVK6401
• NIH Device Record Key: b9a9a341-8ac5-4cb7-8865-c87851efa7d4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Thermafil
• Version Model Number: SVK640
• Catalog Number: SVK640
• Company DUNS: 942778564
• Company Name: TULSA DENTAL PRODUCTS LLC
• Device Count: 1
• DM Exempt: false
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D716SVK6401 [Primary]

FDA Product Code

• EIL: GAUGE, DEPTH, INSTRUMENT, DENTAL

Sterilization

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

[D716SVK6401]

Moist Heat or Steam Sterilization

[D716SVK6401]

Moist Heat or Steam Sterilization

[D716SVK6401]

Moist Heat or Steam Sterilization

[D716SVK6401]

Moist Heat or Steam Sterilization

[D716SVK6401]

Moist Heat or Steam Sterilization

[D716SVK6401]

Moist Heat or Steam Sterilization

[D716SVK6401]

Moist Heat or Steam Sterilization

[D716SVK6401]

Moist Heat or Steam Sterilization

[D716SVK6401]

Moist Heat or Steam Sterilization

[D716SVK6401]

Moist Heat or Steam Sterilization

[D716SVK6401]

Moist Heat or Steam Sterilization

[D716SVK6401]

Moist Heat or Steam Sterilization

[D716SVK6401]

Moist Heat or Steam Sterilization

[D716SVK6401]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-09-07
• Device Publish Date: 2022-08-30

On-Brand Devices [Thermafil]

• D716SVK6401: Verifier: PL 6pk 40/25mm
• D716SVK6351: Verifier: PL 6pk 35/25mm
• D716SVK6301: Verifier: PL 6pk 30/25mm
• D716SVK6251: Verifier: PL 6pk 25/25mm
• D716SVK6201: Verifier: PL 6pk 20/25mm
• D716TSLPLUS1: Sealer: Thermaseal Plus