ENVY Self Adhesive Resin Cement-A2 Shade 980-00

GUDID 00766054000334

Resin Cement Syringeable Dual Cure A2 Shade

ESSENTIAL DENTAL SYSTEMS, INC.

Dental composite resin

• Primary Device ID: 00766054000334
• NIH Device Record Key: 2dc7ed85-b3f8-42c8-8574-fa3b9ba483e1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ENVY Self Adhesive Resin Cement-A2 Shade
• Version Model Number: 980-00
• Catalog Number: 980-00
• Company DUNS: 101147171
• Company Name: ESSENTIAL DENTAL SYSTEMS, INC.
• Device Count: 1
• DM Exempt: true
• 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: true
• 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(201)487-9090
• Email: udi@edsdental.com
• Phone: +1(201)487-9090
• Email: udi@edsdental.com
• Phone: +1(201)487-9090
• Email: udi@edsdental.com
• Phone: +1(201)487-9090
• Email: udi@edsdental.com
• Phone: +1(201)487-9090
• Email: udi@edsdental.com
• Phone: +1(201)487-9090
• Email: udi@edsdental.com
• Phone: +1(201)487-9090
• Email: udi@edsdental.com
• Phone: +1(201)487-9090
• Email: udi@edsdental.com
• Phone: +1(201)487-9090
• Email: udi@edsdental.com
• Phone: +1(201)487-9090
• Email: udi@edsdental.com
• Phone: +1(201)487-9090
• Email: udi@edsdental.com
• Phone: +1(201)487-9090
• Email: udi@edsdental.com
• Phone: +1(201)487-9090
• Email: udi@edsdental.com
• Phone: +1(201)487-9090
• Email: udi@edsdental.com
• Phone: +1(201)487-9090
• Email: udi@edsdental.com
• Phone: +1(201)487-9090
• Email: udi@edsdental.com
• Phone: +1(201)487-9090
• Email: udi@edsdental.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Operating and Storage Conditions

• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 77 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00766054000334 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152691

FDA Product Code

• EMA: CEMENT, DENTAL

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: 2017-02-01

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• 00766054002970 - BIOSEAL: 2024-11-08 EndoTips
• 00766054002901 - Bio-LCB: 2022-11-07 Light Cured Base and Liner Syrinageable
• 00766054002918 - Bio-LCB: 2022-11-07 Light Cured Base and Liner Syrinageable
• 00766054002925 - Bio-LCB: 2022-11-07 50 Light Cured Base and Liner Syringe Tips