Permlastic

GUDID 00841396118661

Impression material catalyst, heavy bodied

Kerr Corporation

Polysulfide dental impression material

• Primary Device ID: 00841396118661
• NIH Device Record Key: 3b095acc-4b99-422c-bebd-ed5236db055a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Permlastic
• Version Model Number: 00502
• Company DUNS: 199354556
• Company Name: Kerr Corporation
• 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

Customer Support Contacts

• Phone: 1-800-5377123
• Email: customercare@kavokerrgroup.com
• Phone: 1-800-5377123
• Email: customercare@kavokerrgroup.com
• Phone: 1-800-5377123
• Email: customercare@kavokerrgroup.com
• Phone: 1-800-5377123
• Email: customercare@kavokerrgroup.com
• Phone: 1-800-5377123
• Email: customercare@kavokerrgroup.com
• Phone: 1-800-5377123
• Email: customercare@kavokerrgroup.com
• Phone: 1-800-5377123
• Email: customercare@kavokerrgroup.com
• Phone: 1-800-5377123
• Email: customercare@kavokerrgroup.com
• Phone: 1-800-5377123
• Email: customercare@kavokerrgroup.com
• Phone: 1-800-5377123
• Email: customercare@kavokerrgroup.com
• Phone: 1-800-5377123
• Email: customercare@kavokerrgroup.com
• Phone: 1-800-5377123
• Email: customercare@kavokerrgroup.com
• Phone: 1-800-5377123
• Email: customercare@kavokerrgroup.com
• Phone: 1-800-5377123
• Email: customercare@kavokerrgroup.com
• Phone: 1-800-5377123
• Email: customercare@kavokerrgroup.com
• Phone: 1-800-5377123
• Email: customercare@kavokerrgroup.com

Device Dimensions

• Weight: 70 Gram
• Weight: 70 Gram
• Weight: 70 Gram
• Weight: 70 Gram
• Weight: 70 Gram
• Weight: 70 Gram
• Weight: 70 Gram
• Weight: 70 Gram
• Weight: 70 Gram
• Weight: 70 Gram
• Weight: 70 Gram
• Weight: 70 Gram
• Weight: 70 Gram
• Weight: 70 Gram
• Weight: 70 Gram
• Weight: 70 Gram

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 28 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841396118661 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K003650

FDA Product Code

• ELW: Material, Impression

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2024-11-04
• Device Publish Date: 2021-04-20

On-Brand Devices [Permlastic]

• 10841396118767: Impression material, bulk package, light bodied (base and catalyst)
• 10841396118750: Impression material, bulk package, regular bodied (base and catalyst)
• 10841396118743: Impression material, bulk package, heavy bodied (base and catalyst)
• 00841396118722: Impression material, standard package, light bodied (base and catalyst)
• 00841396118715: Impression material, standard package, regular bodied (base and catalyst)
• 00841396118708: Impression material, standard package, heavy bodied (base and catalyst)
• 00841396118685: Impression material catalyst, light bodied
• 00841396118678: Impression material base, light bodied
• 00841396118661: Impression material catalyst, heavy bodied
• 00841396118654: Impression material base, heavy bodied
• 00841396118647: Impression material catalyst, regular bodied
• 00841396118630: Impression material base, regular bodied