Hyflex

GUDID D661H083921

Hyflex X-File NT #45-#80 x 21mm File

COLTENE/WHALEDENT INC

Rotary/reciprocating endodontic file/rasp, reusable

• Primary Device ID: D661H083921
• NIH Device Record Key: 309ea1a3-0879-4d3e-8726-ba84711c7aec
• Commercial Distribution Discontinuation: 2025-02-03
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Hyflex
• Version Model Number: H08392
• Company DUNS: 622185718
• Company Name: COLTENE/WHALEDENT INC
• Device Count: 6
• 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: false
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D661H083920 [Unit of Use]
HIBCC	D661H083921 [Primary]

FDA Product Code

• EKS: File, Pulp Canal, Endodontic

Sterilization

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

[D661H083921]

Moist Heat or Steam Sterilization

[D661H083921]

Moist Heat or Steam Sterilization

[D661H083921]

Moist Heat or Steam Sterilization

[D661H083921]

Moist Heat or Steam Sterilization

[D661H083921]

Moist Heat or Steam Sterilization

[D661H083921]

Moist Heat or Steam Sterilization

[D661H083921]

Moist Heat or Steam Sterilization

[D661H083921]

Moist Heat or Steam Sterilization

[D661H083921]

Moist Heat or Steam Sterilization

[D661H083921]

Moist Heat or Steam Sterilization

[D661H083921]

Moist Heat or Steam Sterilization

[D661H083921]

Moist Heat or Steam Sterilization

[D661H083921]

Moist Heat or Steam Sterilization

[D661H083921]

Moist Heat or Steam Sterilization

[D661H083921]

Moist Heat or Steam Sterilization

[D661H083921]

Moist Heat or Steam Sterilization

[D661H083921]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2025-02-04
• Device Publish Date: 2019-02-26

On-Brand Devices [Hyflex]

• D661H084141: Hyflex X-File NT #45-#80 x 25mm File
• D661H084131: Hyflex X-File NT #15-#40 x 25mm File
• D661H084121: Hyflex X-File NT #80 x 25mm File
• D661H084111: Hyflex X-File NT #70 x 25mm File
• D661H084101: Hyflex X-File NT #60 x 25mm File
• D661H084091: Hyflex X-File NT #55 x 25mm File
• D661H084081: Hyflex X-File NT #50 x 25mm File
• D661H084071: Hyflex X-File NT #45 x 25mm File
• D661H084061: Hyflex X-File NT #40 x 25mm File
• D661H084041: Hyflex X-File NT #35 x 25mm File
• D661H084021: Hyflex X-File NT #30 x 25mm File
• D661H084001: Hyflex X-File NT #25 x 25mm File
• D661H083981: Hyflex X-File NT #20 x 25mm File
• D661H083961: Hyflex X-File NT #15 x 25mm File
• D661H083941: Hyflex X-File SS #10 x 25mm File
• D661H083931: Hyflex X-File SS #08 x 25mm File
• D661H083921: Hyflex X-File NT #45-#80 x 21mm File
• D661H083911: Hyflex X-File NT #15-#40 x 21mm File
• D661H083901: Hyflex X-File NT #80 x 21mm File
• D661H083891: Hyflex X-File NT #70 x 21mm File
• D661H083881: Hyflex X-File NT #60 x 21mm File
• D661H083871: Hyflex X-File NT #55 x 21mm File
• D661H083861: Hyflex X-File NT #50 x 21mm File
• D661H083851: Hyflex X-File NT #45 x 21mm File
• D661H083841: Hyflex X-File NT #40 x 21mm File
• D661H083821: Hyflex X-File NT #35 x 21mm File
• D661H083801: Hyflex X-File NT #30 x 21mm File
• D661H083781: Hyflex X-File NT #25 x 21mm File
• D661H083761: Hyflex X-File NT #20 x 21mm File
• D661H083741: Hyflex X-File NT #15 x 21mm File
• D661H083721: Hyflex X-File SS #10 x 21mm File
• D661H083711: Hyflex X-File SS #08 x 21mm File