Diamond D 1013070

GUDID H66810130701

Denture Acrylic HC Light 25 lb P&L

Keystone Industries

Dental appliance fabrication material, cured

• Primary Device ID: H66810130701
• NIH Device Record Key: 6affeeb1-7f6b-4935-8c0b-cb5a8d16480f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Diamond D
• Version Model Number: 1013070
• Catalog Number: 1013070
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from moisture
• Storage Environment Temperature: Between 15 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from moisture
• Storage Environment Temperature: Between 15 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from moisture
• Storage Environment Temperature: Between 15 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from moisture
• Storage Environment Temperature: Between 15 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from moisture
• Storage Environment Temperature: Between 15 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from moisture
• Storage Environment Temperature: Between 15 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from moisture
• Storage Environment Temperature: Between 15 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from moisture
• Storage Environment Temperature: Between 15 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from moisture
• Storage Environment Temperature: Between 15 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from moisture
• Storage Environment Temperature: Between 15 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from moisture
• Storage Environment Temperature: Between 15 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from moisture
• Storage Environment Temperature: Between 15 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from moisture
• Storage Environment Temperature: Between 15 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from moisture
• Storage Environment Temperature: Between 15 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from moisture
• 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	H66810130701 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K032773

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: 4
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-15

On-Brand Devices [Diamond D]

• H66810131161: Denture Acrylic SC Dk Veined 5 lb P&L
• H66810131151: Denture Acrylic SC Dk Veined 1 lb P&L
• H66810131141: Denture Acrylic HC Dk Veined 25 lb P&L
• H66810131131: Denture Acrylic HC Dk Veined 5 lb P&L
• H66810131121: Denture Acrylic HC Dk Veined 1 lb P&L
• H66810131111: Denture Acrylic SC Dk Veined
• H66810131101: Denture Acrylic SC Dk Veined
• H66810131091: Denture Acrylic SC Dk Veined
• H66810131071: Denture Acrylic HC Dk Veined
• H66810131061: Denture Acrylic HC Dk Veined
• H66810131051: Denture Acrylic HC Dk Veined
• H66810131031: Denture Acrylic HC Dk Veined, 20 min Liq. 1 lb P&L
• H66810131011: Denture Acrylic HC LRP, 20 min Liq. 1 lb P&L
• H66810131001: Denture Acrylic HC Light, 20 min Liq. 1 lb P&L
• H66810130991: Denture Acrylic HC Original, 20 min Liq. 1 lb P&L
• H66810130981: Sample Denture Acrylic Original 20 min Liq. 150 g P&L
• H66810130971: Sample Denture Acrylic LRP, 20 min Liq. 150 g P&L
• H66810130941: Denture Acrylic 20 min liquid
• H66810130931: Denture Acrylic 20 min liquid
• H66810130921: Denture Acrylic Sample HC Orig 150g P&L
• H66810130911: Denture Acrylic HC LRP 150 g P&L
• H66810130831: Denture Acrylic SC Lrp 25 lb P&L
• H66810130821: Denture Acrylic SC Light 25 lb P&L
• H66810130811: Denture Acrylic SC Orig 25 lb P&L
• H66810130791: Denture Acrylic SC Lrp 5 lb P&L
• H66810130781: Denture Acrylic SC Light 5 lb P&L
• H66810130771: Denture Acrylic SC Orig 5 lb P&L
• H66810130751: Denture Acrylic SC Lrp 1 lb P&L
• H66810130741: Denture Acrylic SC Light 1 lb P&L
• H66810130731: Denture Acrylic SC Orig 1 lb P&L
• H66810130721: Denture Acrylic HC 25 lb Chroma Essence P&L
• H66810130711: Denture Acrylic HC Lrp 25 lb P& L
• H66810130701: Denture Acrylic HC Light 25 lb P&L
• H66810130691: Denture Acrylic HC Orig 25 lb P&L
• H66810130681: Denture Acrylic HC Chroma Essence 5 lb P&L
• H66810130671: Denture Acrylic HC Lrp 5 lb P& L
• H66810130661: Denture Acrylic HC Light 5 lb P&L
• H66810130651: Denture Acrylic HC Orig 5 lb P&L
• H66810130641: Denture Acrylic HC Chroma Essence 1 lb P&L
• H66810130631: Denture Acrylic HC Lrp 1 lb P& L
• H66810130621: Denture Acrylic HC Light 1 lb P& L
• H66810130611: Denture Acrylic HC Orig 1 lb P& L
• H66810130601: Denture Acrylic SC Lrp Pwd
• H66810130591: Denture Acrylic SC Lrp Pwd
• H66810130581: Denture Acrylic SC Lrp Pwd
• H66810130561: Denture Acrylic SC Light Pwd
• H66810130551: Denture Acrylic SC Light Pwd
• H66810130541: Denture Acrylic SC Light Pwd
• H66810130521: Denture Acrylic SC Orig Pwd
• H66810130511: Denture Acrylic SC Orig Pwd