MIRIS2 8446

GUDID J00684460

Coltène/Whaledent AG

Dental veneer, professional

• Primary Device ID: J00684460
• NIH Device Record Key: 7258c3df-cdb1-4979-a53d-cce5aafdbe59
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MIRIS2
• Version Model Number: 8446
• Catalog Number: 8446
• Company DUNS: 480017482
• Company Name: Coltène/Whaledent AG
• 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: +41717575300
• Email: info.ch@coltene.com
• Phone: +41717575300
• Email: info.ch@coltene.com
• Phone: +41717575300
• Email: info.ch@coltene.com
• Phone: +41717575300
• Email: info.ch@coltene.com
• Phone: +41717575300
• Email: info.ch@coltene.com
• Phone: +41717575300
• Email: info.ch@coltene.com
• Phone: +41717575300
• Email: info.ch@coltene.com
• Phone: +41717575300
• Email: info.ch@coltene.com
• Phone: +41717575300
• Email: info.ch@coltene.com
• Phone: +41717575300
• Email: info.ch@coltene.com
• Phone: +41717575300
• Email: info.ch@coltene.com
• Phone: +41717575300
• Email: info.ch@coltene.com
• Phone: +41717575300
• Email: info.ch@coltene.com
• Phone: +41717575300
• Email: info.ch@coltene.com
• Phone: +41717575300
• Email: info.ch@coltene.com
• Phone: +41717575300
• Email: info.ch@coltene.com
• Phone: +41717575300
• Email: info.ch@coltene.com
• Phone: +41717575300
• Email: info.ch@coltene.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *KEEP AWAY FROM SUNLIGHT
• Storage Environment Temperature: Between 4 Degrees Celsius and 23 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *KEEP AWAY FROM SUNLIGHT
• Storage Environment Temperature: Between 4 Degrees Celsius and 23 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *KEEP AWAY FROM SUNLIGHT
• Storage Environment Temperature: Between 4 Degrees Celsius and 23 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *KEEP AWAY FROM SUNLIGHT
• Storage Environment Temperature: Between 4 Degrees Celsius and 23 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *KEEP AWAY FROM SUNLIGHT
• Storage Environment Temperature: Between 4 Degrees Celsius and 23 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *KEEP AWAY FROM SUNLIGHT
• Storage Environment Temperature: Between 4 Degrees Celsius and 23 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *KEEP AWAY FROM SUNLIGHT
• Storage Environment Temperature: Between 4 Degrees Celsius and 23 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *KEEP AWAY FROM SUNLIGHT
• Storage Environment Temperature: Between 4 Degrees Celsius and 23 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *KEEP AWAY FROM SUNLIGHT
• Storage Environment Temperature: Between 4 Degrees Celsius and 23 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *KEEP AWAY FROM SUNLIGHT
• Storage Environment Temperature: Between 4 Degrees Celsius and 23 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *KEEP AWAY FROM SUNLIGHT
• Storage Environment Temperature: Between 4 Degrees Celsius and 23 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *KEEP AWAY FROM SUNLIGHT
• Storage Environment Temperature: Between 4 Degrees Celsius and 23 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *KEEP AWAY FROM SUNLIGHT
• Storage Environment Temperature: Between 4 Degrees Celsius and 23 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *KEEP AWAY FROM SUNLIGHT
• Storage Environment Temperature: Between 4 Degrees Celsius and 23 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *KEEP AWAY FROM SUNLIGHT
• Storage Environment Temperature: Between 4 Degrees Celsius and 23 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *KEEP AWAY FROM SUNLIGHT
• Storage Environment Temperature: Between 4 Degrees Celsius and 23 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *KEEP AWAY FROM SUNLIGHT
• Storage Environment Temperature: Between 4 Degrees Celsius and 23 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *KEEP AWAY FROM SUNLIGHT
• Storage Environment Temperature: Between 4 Degrees Celsius and 23 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	J00684460 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K974465

FDA Product Code

• EBF: Material, Tooth Shade, Resin

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: 2023-07-13
• Device Publish Date: 2016-08-15

On-Brand Devices [MIRIS2]

• J00684650: 8465
• J00684310: 8431
• J00684970: 8497
• J00684950: 8495
• J00684940: 8494
• J00684920: 8492
• J00684910: 8491
• J00684870: 8487
• J00684860: 8486
• J00684800: 8480
• J00684790: 8479
• J00684780: 8478
• J00684760: 8476
• J00684750: 8475
• J00684730: 8473
• J00684720: 8472
• J00684460: 8446
• J00684430: 8443
• J00684420: 8442
• J00684380: 8438
• J00684370: 8437
• J00684350: 8435
• J00684060: 8406
• J006600193690: 60019369
• J00684960: 8496
• J00684930: 8493
• J00684900: 8490
• J00684890: 8489
• J00684880: 8488
• J00684830: 8483
• J00684820: 8482
• J00684810: 8481
• J00684740: 8474
• J00684470: 8447
• J00684450: 8445
• J00684410: 8441
• J00684400: 8440
• J00684390: 8439
• J00684360: 8436
• J00684340: 8434
• J00684330: 8433
• J00684320: 8432
• J00684090: 8409
• J00684080: 8408
• J006600193700: 60019370