KeyPrint 4200008

GUDID H66842000081

KeyOrtho IBT 0.5KG

Keystone Industries

Dental appliance fabrication material, resin

• Primary Device ID: H66842000081
• NIH Device Record Key: 6df7bbd7-3ea9-48bb-b349-7528524e0651
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: KeyPrint
• Version Model Number: 4200008
• Catalog Number: 4200008
• Company DUNS: 073503117
• Company Name: Keystone Industries
• 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: 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

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

Device Dimensions

• Total Volume: 17.6 Fluid Ounce
• Weight: 0.5 Kilogram
• Total Volume: 17.6 Fluid Ounce
• Weight: 0.5 Kilogram
• Total Volume: 17.6 Fluid Ounce
• Weight: 0.5 Kilogram
• Total Volume: 17.6 Fluid Ounce
• Weight: 0.5 Kilogram
• Total Volume: 17.6 Fluid Ounce
• Weight: 0.5 Kilogram
• Total Volume: 17.6 Fluid Ounce
• Weight: 0.5 Kilogram
• Total Volume: 17.6 Fluid Ounce
• Weight: 0.5 Kilogram
• Total Volume: 17.6 Fluid Ounce
• Weight: 0.5 Kilogram

Operating and Storage Conditions

• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• 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 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• 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 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• 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 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• 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 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• 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 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• 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 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• 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 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	H66842000081 [Primary]

FDA Product Code

• QJJ: Indirect bonding tray

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: 2022-12-08
• Device Publish Date: 2022-11-30

On-Brand Devices [KeyPrint]

• H66842201551: Keysplint Soft Clear for Carbon 1kg
• H66842200051: Keysplint Soft 1 kg
• H66842001551: Keysplint Soft Clear for Carbon sample
• H66842000051: Keysplint Soft sample
• H66842200042: KeySplint Hard 1 kg
• H66842000042: KeySplint Hard 0.5 kg sample
• H66850522011: KeyGuide 0.5 KG for Nexa 3D Printers
• H66842204201: KeyDenture Try In, BL4, 1 KG
• H66842204061: KeyDenture Try In, B1, 1 KG
• H66842204011: KeyDenture Try In, A1, 1 KG
• H66842200081: KeyOrtho IBT 1KG
• H66842200011: KeyGuide 1 KG
• H66842004201: KeyDenture Try In, BL4, 0.5 KG
• H66842004061: KeyDenture Try In, B1, 0.5 KG
• H66842004011: KeyDenture Try In, A1, 0.5 KG
• H66842000081: KeyOrtho IBT 0.5KG
• H66842000011: KeyGuide 0.5 KG
• H66842201612: KeySplint Soft Clear Resin ,1kg
• H66842200112: KeySplint Hard Clear Resin 1kg
• H66842001612: KeySplint Soft Clear Resin, 0.5kg
• H66842000112: KeySplint Hard Clear Resin 0.5 KG
• H66842201512: KeySplint Soft Pink 1kg
• H66841101412: KeySplint Hard Pink 1kg
• H66842000100: 3D Intro Kit