Acupac® 4300-00P

GUDID B715430000P0

Acupac® Light

FRICKE INTERNATIONAL, INC.

Dental appliance fabrication material, cured

• Primary Device ID: B715430000P0
• NIH Device Record Key: 1427d06b-57ae-4b16-87eb-928a5a9524bb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Acupac®
• Version Model Number: 4300-00P
• Catalog Number: 4300-00P
• Company DUNS: 957630726
• Company Name: FRICKE INTERNATIONAL, INC.
• 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: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 630-540-1900
• Email: customerservice@frickedental.c
• Phone: 630-540-1900
• Email: customerservice@frickedental.com
• Phone: 630-540-1900
• Email: customerservice@frickedental.com
• Phone: 630-540-1900
• Email: customerservice@frickedental.com
• Phone: 630-540-1900
• Email: customerservice@frickedental.com
• Phone: 630-540-1900
• Email: customerservice@frickedental.com
• Phone: 630-540-1900
• Email: customerservice@frickedental.com
• Phone: 630-540-1900
• Email: customerservice@frickedental.com
• Phone: 630-540-1900
• Email: customerservice@frickedental.com
• Phone: 630-540-1900
• Email: customerservice@frickedental.com
• Phone: 630-540-1900
• Email: customerservice@frickedental.com
• Phone: 630-540-1900
• Email: customerservice@frickedental.com
• Phone: 630-540-1900
• Email: customerservice@frickedental.com
• Phone: 630-540-1900
• Email: customerservice@frickedental.com
• Phone: 630-540-1900
• Email: customerservice@frickedental.com
• Phone: 630-540-1900
• Email: customerservice@frickedental.com

Device Dimensions

• Weight: 5 Pound
• Weight: 5 Pound
• Weight: 5 Pound
• Weight: 5 Pound
• Weight: 5 Pound
• Weight: 5 Pound
• Weight: 5 Pound
• Weight: 5 Pound
• Weight: 5 Pound
• Weight: 5 Pound
• Weight: 5 Pound
• Weight: 5 Pound
• Weight: 5 Pound
• Weight: 5 Pound
• Weight: 5 Pound
• Weight: 5 Pound

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B715430000P0 [Primary]

FDA Product Code

• EBI: Resin, Denture, Relining, Repairing, Rebasing

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: 2019-04-10
• Device Publish Date: 2019-04-02

On-Brand Devices [Acupac®]

• B7154420100: Acupac® 30 Monomer
• B715430007P0: Acupac® 30 Natural
• B715430006P0: Acupac® Ethnic Dark
• B715430003P0: Acupac® Natural
• B715430000P0: Acupac® Light
• B715412010P0: Acupac® 30 Light
• B715430001025P0: Acupac® Medium
• B715430002025P0: Acupac® Characterized Medium
• B715430002P0: Acupac® Characterized Medium
• B7154300020480: Acupac® Characterized Medium
• B7154300060480: Acupac® Ethnic Dark
• B7154300060010: Acupac® Ethnic Dark
• B7154300000010: Acupac® Light
• B7154300020010: Acupac® Char Medium
• B715412011P0: Acupac® 30 Char Medium
• B7154120110480: Acupac® 30 Char Medium
• B7154120110010: Acupac® 30 Char Medium
• B7154420000: Acupac® 30 Monomer
• B7154300030010: Acupac® Natural
• B7154300010010: Acupac® Medium
• B715430001P0: Acupac® Medium
• B715430000025P0: Acupac® Light
• B715412008P0: Acupac® 30 Medium
• B71508025025P0: Memphis L/M