Mizzy Millennium 6010035

GUDID H66860100351

Denture Acrylic HC Deep Veined 25 lb P& L

Keystone Industries

Dental appliance fabrication material, cured

• Primary Device ID: H66860100351
• NIH Device Record Key: e7c6b30d-51af-43ba-91fa-fe77533d823e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Mizzy Millennium
• Version Model Number: 6010035
• Catalog Number: 6010035
• Company DUNS: 073503117
• Company Name: Keystone Industries
• 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: true
• 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

Customer Support Contacts

• Phone: +1(800)333-3131
• Email: tschwear@keystoneind.com
• Phone: +1(800)333-3131
• Email: tschwear@keystoneind.com
• Phone: +1(800)333-3131
• Email: tschwear@keystoneind.com
• Phone: +1(800)333-3131
• Email: tschwear@keystoneind.com
• Phone: +1(800)333-3131
• Email: tschwear@keystoneind.com
• Phone: +1(800)333-3131
• Email: tschwear@keystoneind.com
• Phone: +1(800)333-3131
• Email: tschwear@keystoneind.com
• Phone: +1(800)333-3131
• Email: tschwear@keystoneind.com
• Phone: +1(800)333-3131
• Email: tschwear@keystoneind.com
• Phone: +1(800)333-3131
• Email: tschwear@keystoneind.com
• Phone: +1(800)333-3131
• Email: tschwear@keystoneind.com
• Phone: +1(800)333-3131
• Email: tschwear@keystoneind.com
• Phone: +1(800)333-3131
• Email: tschwear@keystoneind.com
• Phone: +1(800)333-3131
• Email: tschwear@keystoneind.com
• Phone: +1(800)333-3131
• Email: tschwear@keystoneind.com
• Phone: +1(800)333-3131
• Email: tschwear@keystoneind.com
• Phone: +1(800)333-3131
• Email: tschwear@keystoneind.com
• Phone: +1(800)333-3131
• Email: tschwear@keystoneind.com
• Phone: +1(800)333-3131
• Email: tschwear@keystoneind.com
• Phone: +1(800)333-3131
• Email: tschwear@keystoneind.com
• Phone: +1(800)333-3131
• Email: tschwear@keystoneind.com
• Phone: +1(800)333-3131
• Email: tschwear@keystoneind.com
• Phone: +1(800)333-3131
• Email: tschwear@keystoneind.com
• Phone: +1(800)333-3131
• Email: tschwear@keystoneind.com
• Phone: +1(800)333-3131
• Email: tschwear@keystoneind.com
• Phone: +1(800)333-3131
• Email: tschwear@keystoneind.com
• Phone: +1(800)333-3131
• Email: tschwear@keystoneind.com
• Phone: +1(800)333-3131
• Email: tschwear@keystoneind.com
• Phone: +1(800)333-3131
• Email: tschwear@keystoneind.com
• Phone: +1(800)333-3131
• Email: tschwear@keystoneind.com
• Phone: +1(800)333-3131
• Email: tschwear@keystoneind.com
• Phone: +1(800)333-3131
• Email: tschwear@keystoneind.com
• Phone: +1(800)333-3131
• Email: tschwear@keystoneind.com
• Phone: +1(800)333-3131
• Email: tschwear@keystoneind.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	H66860100351 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K983876

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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-15

On-Brand Devices [Mizzy Millennium]

• H66860100491: Denture Acrylic QC Liquid
• H66860100481: Denture Acrylic QC Liquid
• H66860100461: Denture Acrylic HC Liquid
• H66860100451: Denture Acrylic HC Liquid
• H66860100431: Denture Acrylic QC Deep Veined 5 lb P& L
• H66860100421: Denture Acrylic QC Lt Veined 5 lb P& L
• H66860100401: Denture Acrylic QC Clear 1 lb P& L
• H66860100391: Denture Acrylic QC Deep Veined 1 lb P& L
• H66860100381: Denture Acrylic QC Lt Veined 5 lb P& L
• H66860100351: Denture Acrylic HC Deep Veined 25 lb P& L
• H66860100341: Denture Acrylic HC Lt Veined 25 lb P& L
• H66860100321: Denture Acrylic HC Clear 5 lb P& L
• H66860100311: Denture Acrylic HC Deep Veined 5 lb P& L
• H66860100301: Denture Acrylic HC Lt Veined 5 lb P& L
• H66860100281: Denture Acrylic HC Clear 1 lb P& L
• H66860100271: Denture Acrylic HC Deep Veined 1 lb P& L
• H66860100261: Denture Acrylic HC Lt Veined 1 lb P& L
• H66860100241: Denture Acrylic QC Pwd Clear
• H66860100221: Denture Acrylic QC Pwd Lt Veined
• H66860100201: Denture Acrylic QC Pwd Clear
• H66860100191: Denture Acrylic QC Pwd Deep Veined
• H66860100181: Denture Acrylic QC Pwd Lt Veined
• H66860100161: Denture Acrylic QC Pwd Clear
• H66860100151: Denture Acrylic QC Pwd Deep Veined
• H66860100141: Denture Acrylic QC Pwd Lt Veined
• H66860100111: Denture Acrylic HC Pwd Deep Veined
• H66860100101: Denture Acrylic HC Pwd Lt Veined
• H66860100081: Denture Acrylic HC Pwd Clear
• H66860100071: Denture Acrylic HC Pwd Deep Veined
• H66860100061: Denture Acrylic HC Pwd Lt Veined
• H66860100041: Denture Acrylic HC Pwd Clear
• H66860100031: Denture Acrylic HC Pwd Deep Veined
• H66860100021: Denture Acrylic HC Pwd Lt Veined
• H66810143741: Pour Acrylic Lt Reddish Pink 25lb Pwd, 4 Qts Liquid
• H66810143631: Pour Acrylic Lt Fibered Plus 5 lb Pwd, 1 Qt Liquid
• H66810143621: Pour Acrylic Lt Fibered Orig 5 lb Pwd, 1 Qt Liquid
• H66810143611: Pour Acrylic Heavy Veined 5 lb Pwd, 1 Qt Liquid
• H66810143601: Pour Acrylic Clear 5 lb Pwd, 1 Qt Liquid
• H66810143531: Pour Acrylic Lt Fibered Plus 1lb Pwd, 8 oz Liquid
• H66810143521: Pour Acrylic Lt Fibered Orig 1lb Pwd, 8 oz Liquid
• H66810143511: Pour Acrylic Heavy Veined 1lb Pwd, 8 oz Liquid
• H66810143501: Pour Acrylic Clear 1lb Pwd, 8 oz Liquid
• H66810143421: Pour Acrylic Light Reddish Pink Pwd
• H66810143371: Pour Acrylic Light Fibered Plus Pwd
• H66810143361: Pour Acrylic Light Fibered Plus Pwd
• H66810143351: Pour Acrylic Light Fibered Plus Pwd
• H66810143321: Pour Acrylic Light Fibered Original Pwd
• H66810143311: Pour Acrylic Light Fibered Original Pwd
• H66810143301: Pour Acrylic Light Fibered Original Pwd
• H66810143261: Pour Acrylic Heavy Veined Pwd