OPTIMUM

GUDID 00366975011640

#80 Black Optimum™ Hedstroms File 21mm Pack of 6

BENCO DENTAL SUPPLY CO.

Manual endodontic file/rasp, reusable

• Primary Device ID: 00366975011640
• NIH Device Record Key: 1fc3bc87-8579-4e75-b2a0-a89958777cdf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OPTIMUM
• Version Model Number: 4448-966
• Company DUNS: 015108087
• Company Name: BENCO DENTAL SUPPLY CO.
• 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: 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

Customer Support Contacts

• Phone: 570-602-6924
• Email: jsoroka@benco.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00366975011640 [Primary]

FDA Product Code

• EKS: File, Pulp Canal, Endodontic

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-12-07
• Device Publish Date: 2018-10-02

On-Brand Devices [OPTIMUM]

• 00366975032966: REAMERS ENGINE SS 21MM #30 PK6
• 00366975032959: #08 Gray Optimum™ Reamers 31mm Pack of 6
• 00366975030450: #110 Red Optimum™ Reamers 21mm Pack of 6
• 00366975030443: #60 Blue Optimum™ Hedstroms File 21mm Pack of 6
• 00366975030436: REAMERS ENGINE SS 21MM #45 PK6
• 00366975030429: REAMERS ENGINE SS 21MM #40 PK6
• 00366975030412: REAMERS ENGINE SS 21MM #35 PK6
• 00366975030405: REAMERS ENGINE SS 21MM #25 PK6
• 00366975030399: REAMERS ENGINE SS 21MM #20 PK6
• 00366975030382: REAMERS ENGINE SS 21MM #10 PK6
• 00366975012203: #110 Red Optimum™ Hedstroms File 21mm Pack of 6
• 00366975012197: #110 Red Optimum™ Reamers 31mm Pack of 6
• 00366975012180: #70 Green Optimum™ Reamers 21mm Pack of 6
• 00366975012173: #60 Blue Optimum™ Reamers 21mm Pack of 6
• 00366975012166: #55 Red Optimum™ Reamers 21mm Pack of 6
• 00366975012159: #45-80 Assorted Optimum™ Reamers 21mm Pack of 6
• 00366975012142: #35 Green Optimum™ Reamers 21mm Pack of 6
• 00366975012135: REAMERS ENGINE SS 21MM #15 PK6
• 00366975012128: #15-40 Assorted Optimum™ Reamers 21mm Pack of 6
• 00366975012111: #40 Black Optimum™ Reamers 21mm Pack of 6
• 00366975012104: #50 Yellow Optimum™ Reamers 21mm Pack of 6
• 00366975012098: #45 White Optimum™ Reamers 21mm Pack of 6
• 00366975012081: #30 Blue Optimum™ Reamers 21mm Pack of 6
• 00366975012074: #80 Black Optimum™ Reamers 21mm Pack of 6
• 00366975012067: #45-80 Assorted Optimum™ Reamers 25mm Pack of 6
• 00366975012050: #15 White Optimum™ Reamers 31mm Pack of 6
• 00366975012043: #80 Black Optimum™ Reamers 31mm Pack of 6
• 00366975012036: #70 Green Optimum™ Reamers 31mm Pack of 6
• 00366975012029: #55 Red Optimum™ Reamers 31mm Pack of 6
• 00366975012012: #40 Black Optimum™ Reamers 31mm Pack of 6
• 00366975012005: #50 Yellow Optimum™ Reamers 31mm Pack of 6
• 00366975011992: #35 Green Optimum™ Reamers 31mm Pack of 6
• 00366975011978: #08 Gray Optimum™ Reamers 31mm Pack of 6
• 00366975011961: #30 Blue Optimum™ Reamers 31mm Pack of 6
• 00366975011954: #60 Blue Optimum™ Reamers 31mm Pack of 6
• 00366975011947: #45 White Optimum™ Reamers 31mm Pack of 6
• 00366975011930: #20 Yellow Optimum™ Reamers 31mm Pack of 6
• 00366975011923: #60 Blue Optimum™ Reamers 25mm Pack of 6
• 00366975011916: #06 Pink Optimum™ Reamers 31mm Pack of 6
• 00366975011909: #10 Purple Optimum™ Reamers 31mm Pack of 6
• 00366975011893: #15-40 Assorted Optimum™ Reamers 25mm Pack of 6
• 00366975011886: #70 Green Optimum™ Reamers 25mm Pack of 6
• 00366975011879: #06 Pink Optimum™ Reamers 21mm Pack of 6
• 00366975011862: #50 Yellow Optimum™ Reamers 25mm Pack of 6
• 00366975011855: #25 Red Optimum™ Reamers 21mm Pack of 6
• 00366975011848: #40 Black Optimum™ Reamers 25mm Pack of 6
• 00366975011831: #80 Black Optimum™ Reamers 25mm Pack of 6
• 00366975011824: #45 White Optimum™ Reamers 25mm Pack of 6
• 00366975011817: #55 Red Optimum™ Reamers 25mm Pack of 6
• 00366975011800: #08 Gray Optimum™ Reamers 21mm Pack of 6