DHP Nanohybrid Flowable Composite 210-HT10B22

GUDID D773210HT10B221

DHP Nanohybrid Flowable Composite Refill B2 2-2gm syringes

Dental Health Products Inc

Dental composite resin

• Primary Device ID: D773210HT10B221
• NIH Device Record Key: 0fb41678-8d78-4f0f-9108-ab00be65c9db
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DHP Nanohybrid Flowable Composite
• Version Model Number: 210-HT10B22
• Catalog Number: 210-HT10B22
• Company DUNS: 623191194
• Company Name: Dental Health Products 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: false
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D773210HT10B221 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K130672

FDA Product Code

• EBF: Material, Tooth Shade, Resin

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: 2022-10-27
• Device Publish Date: 2022-10-19

On-Brand Devices [DHP Nanohybrid Flowable Composite]

• D773210HT10UO21: DHP Nanohybrid Flowable Composite Refill UO Universal Opaque 2-2gm syringes
• D773210HT10FK21: DHP Nanohybrid Flowable Composite Assorted Intro Kit 4-2gm syringes with 20 Tips
• D773210HT10C321: DHP Nanohybrid Flowable Composite Refill C3 2-2gm syringes
• D773210HT10C221: DHP Nanohybrid Flowable Composite Refill C2 2-2gm syringes
• D773210HT10B221: DHP Nanohybrid Flowable Composite Refill B2 2-2gm syringes
• D773210HT10B121: DHP Nanohybrid Flowable Composite Refill B1 2-2gm syringes
• D773210HT10A421: DHP Nanohybrid Flowable Composite Refill A4 2-2gm syringes
• D773210HT10A3521: DHP Nanohybrid Flowable Composite Refill A3.5 2-2gm syringes
• D773210HT10A321: DHP Nanohybrid Flowable Composite Refill A3 2-2gm syringes
• D773210HT10A221: DHP Nanohybrid Flowable Composite Refill A2 2-2gm syringes
• D773210HT10A121: DHP Nanohybrid Flowable Composite Refill A1 2-2gm syringes