IS-2000

GUDID 00813277020127

Impression Material, Ultra Lite Body Regular

ADA PRODUCTS CO, INC

Silicone dental impression material

• Primary Device ID: 00813277020127
• NIH Device Record Key: 1caec6b0-440c-4095-8342-7bf7b899b2af
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IS-2000
• Version Model Number: 40100
• Company DUNS: 624504028
• Company Name: ADA PRODUCTS CO, INC
• 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: 877-243-7711
• Email: info@adaproducts.net
• Phone: 877-243-7711
• Email: info@adaproducts.net

Operating and Storage Conditions

• Storage Environment Temperature: Between 46 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Storage Environment Temperature: Between 46 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Storage Environment Temperature: Between 46 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Storage Environment Temperature: Between 46 Degrees Fahrenheit and 75 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00813277020127 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K951075

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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-04-10

On-Brand Devices [IS-2000]

• 00813277020288: Impression Material, Heavy Body Fast, Bulk
• 00813277020271: Impression Material, Heavy Body Regular, Bulk
• 00813277020264: Impression Material, Monophase Regular, Bulk
• 00813277020257: Impression Material, Lite Body Fast, Bulk
• 00813277020240: Impression Material, Lite Body Regular, Bulk
• 00813277020233: Impression Material, Ultra Lite Body Regular, Bulk
• 00813277020226: Bite Registration Material, Fast Set
• 00813277020196: Impression Material, Putty Kit (Base & Catalyst)
• 00813277020189: Impression Material, Maximum Monophase Regular
• 00813277020172: Impression Material, Heavy Body Fast
• 00813277020165: Impression Material, Heavy Body Regular
• 00813277020158: Impression Material, Monophase Regular
• 00813277020141: Impression Material, Lite Body Fast
• 00813277020134: Impression Material, Lite Body Regular
• 00813277020127: Impression Material, Ultra Lite Body Regular