HYBENX Advanced Dental Debridement 109-0001

GUDID 00860004740315

HYBENX Advanced Dental Debridement is topical liquid or gel intended for use as an adjunctive decontamination rinse of tooth surfaces during the performance of certain dental procedures to help remove the smear layer and tooth debris.

Epien Medical, Inc.

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• Primary Device ID: 00860004740315
• NIH Device Record Key: 2dc256d5-1ed3-48c8-93a7-6e348a792e9f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HYBENX Advanced Dental Debridement
• Version Model Number: 109-0001
• Catalog Number: 109-0001
• Company DUNS: 128678765
• Company Name: Epien Medical, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Dimensions

• Total Volume: 1.5 Milliliter
• Total Volume: 1.5 Milliliter
• Total Volume: 1.5 Milliliter
• Total Volume: 1.5 Milliliter
• Total Volume: 1.5 Milliliter
• Total Volume: 1.5 Milliliter
• Total Volume: 1.5 Milliliter
• Total Volume: 1.5 Milliliter
• Total Volume: 1.5 Milliliter
• Total Volume: 1.5 Milliliter
• Total Volume: 1.5 Milliliter
• Total Volume: 1.5 Milliliter
• Total Volume: 1.5 Milliliter
• Total Volume: 1.5 Milliliter
• Total Volume: 1.5 Milliliter
• Total Volume: 1.5 Milliliter
• Total Volume: 1.5 Milliliter

Operating and Storage Conditions

• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860004740315 [Primary]

FDA Product Code

• KJJ: Cleanser, Root Canal

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-05-16
• Device Publish Date: 2023-05-08

Devices Manufactured by Epien Medical, Inc.

• 00860004740322 - HYBENX Advanced Dental Debridement Gel: 2023-05-17 HYBENX Advanced Dental Debridement is a topical liquid or gel intended for use as an adjunctive decontamination rinse of tooth s
• 00860004740315 - HYBENX Advanced Dental Debridement: 2023-05-16HYBENX Advanced Dental Debridement is topical liquid or gel intended for use as an adjunctive decontamination rinse of tooth surfaces during the performance of certain dental procedures to help remove the smear layer and tooth debris.
• 00860004740315 - HYBENX Advanced Dental Debridement: 2023-05-16 HYBENX Advanced Dental Debridement is topical liquid or gel intended for use as an adjunctive decontamination rinse of tooth sur
• 00860004740308 - HYBENX Root Canal Cleanser: 2021-05-28 EPIEN Root Canal Cleanser is indicated for use as an adjunctive rinse of tooth root canal systems and adjacent tooth surfaces du