BRILLIANT COMPONEER 60023144

GUDID J00660023144

BRILLIANT COMPONEER are polymerised, prefabricated, highly filled, submicron hybrid composite enamel shells for direct veneering. BRILLIANT COMPONEER upper jaw XL bleach translucent 22.

Coltène/Whaledent AG

Dental veneer, custom-made

• Primary Device ID: J00660023144
• NIH Device Record Key: 9a5caf64-5807-471a-bc14-736a540f0e0a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BRILLIANT COMPONEER
• Version Model Number: 60023144
• Catalog Number: 60023144
• 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: 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: +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 *Store at 4-23 °C / 39-73 °F
• Special Storage Condition, Specify: Between 0 and 0 *Do not expose to direct sunlight or other heat sources
• Special Storage Condition, Specify: Between 0 and 0 *Store at 4-23 °C / 39-73 °F
• Special Storage Condition, Specify: Between 0 and 0 *Do not expose to direct sunlight or other heat sources
• Special Storage Condition, Specify: Between 0 and 0 *Store at 4-23 °C / 39-73 °F
• Special Storage Condition, Specify: Between 0 and 0 *Do not expose to direct sunlight or other heat sources
• Special Storage Condition, Specify: Between 0 and 0 *Store at 4-23 °C / 39-73 °F
• Special Storage Condition, Specify: Between 0 and 0 *Do not expose to direct sunlight or other heat sources
• Special Storage Condition, Specify: Between 0 and 0 *Store at 4-23 °C / 39-73 °F
• Special Storage Condition, Specify: Between 0 and 0 *Do not expose to direct sunlight or other heat sources
• Special Storage Condition, Specify: Between 0 and 0 *Store at 4-23 °C / 39-73 °F
• Special Storage Condition, Specify: Between 0 and 0 *Do not expose to direct sunlight or other heat sources
• Special Storage Condition, Specify: Between 0 and 0 *Store at 4-23 °C / 39-73 °F
• Special Storage Condition, Specify: Between 0 and 0 *Do not expose to direct sunlight or other heat sources
• Special Storage Condition, Specify: Between 0 and 0 *Store at 4-23 °C / 39-73 °F
• Special Storage Condition, Specify: Between 0 and 0 *Do not expose to direct sunlight or other heat sources
• Special Storage Condition, Specify: Between 0 and 0 *Store at 4-23 °C / 39-73 °F
• Special Storage Condition, Specify: Between 0 and 0 *Do not expose to direct sunlight or other heat sources
• Special Storage Condition, Specify: Between 0 and 0 *Store at 4-23 °C / 39-73 °F

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	J00660023144 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191385

FDA Product Code

• EBF: Material, Tooth Shade, Resin

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: 2020-02-17
• Device Publish Date: 2020-02-07

On-Brand Devices [BRILLIANT COMPONEER]

• J00660023193: BRILLIANT COMPONEER are polymerised, prefabricated, highly filled, submicron hybrid composite en
• J00660023192: BRILLIANT COMPONEER are polymerised, prefabricated, highly filled, submicron hybrid composite en
• J00660023184: BRILLIANT COMPONEER are polymerised, prefabricated, highly filled, submicron hybrid composite en
• J00660023181: BRILLIANT COMPONEER are polymerised, prefabricated, highly filled, submicron hybrid composite en
• J00660023176: BRILLIANT COMPONEER are polymerised, prefabricated, highly filled, submicron hybrid composite en
• J00660023175: BRILLIANT COMPONEER are polymerised, prefabricated, highly filled, submicron hybrid composite en
• J00660023174: BRILLIANT COMPONEER are polymerised, prefabricated, highly filled, submicron hybrid composite en
• J00660023173: BRILLIANT COMPONEER are polymerised, prefabricated, highly filled, submicron hybrid composite en
• J00660023172: BRILLIANT COMPONEER are polymerised, prefabricated, highly filled, submicron hybrid composite en
• J00660023171: BRILLIANT COMPONEER are polymerised, prefabricated, highly filled, submicron hybrid composite en
• J00660023170: BRILLIANT COMPONEER are polymerised, prefabricated, highly filled, submicron hybrid composite en
• J00660023167: BRILLIANT COMPONEER are polymerised, prefabricated, highly filled, submicron hybrid composite en
• J00660023166: BRILLIANT COMPONEER are polymerised, prefabricated, highly filled, submicron hybrid composite en
• J00660023156: BRILLIANT COMPONEER are polymerised, prefabricated, highly filled, submicron hybrid composite en
• J00660023154: BRILLIANT COMPONEER are polymerised, prefabricated, highly filled, submicron hybrid composite en
• J00660023150: BRILLIANT COMPONEER are polymerised, prefabricated, highly filled, submicron hybrid composite en
• J00660023214: BRILLIANT COMPONEER are polymerised, prefabricated, highly filled, submicron hybrid composite en
• J00660023213: BRILLIANT COMPONEER are polymerised, prefabricated, highly filled, submicron hybrid composite en
• J00660023212: BRILLIANT COMPONEER are polymerised, prefabricated, highly filled, submicron hybrid composite en
• J00660023211: BRILLIANT COMPONEER are polymerised, prefabricated, highly filled, submicron hybrid composite en
• J00660023210: BRILLIANT COMPONEER are polymerised, prefabricated, highly filled, submicron hybrid composite en
• J00660023209: BRILLIANT COMPONEER are polymerised, prefabricated, highly filled, submicron hybrid composite en
• J00660023207: BRILLIANT COMPONEER are polymerised, prefabricated, highly filled, submicron hybrid composite en
• J00660023206: BRILLIANT COMPONEER are polymerised, prefabricated, highly filled, submicron hybrid composite en
• J00660023204: BRILLIANT COMPONEER are polymerised, prefabricated, highly filled, submicron hybrid composite en
• J00660023203: BRILLIANT COMPONEER are polymerised, prefabricated, highly filled, submicron hybrid composite en
• J00660023200: BRILLIANT COMPONEER are polymerised, prefabricated, highly filled, submicron hybrid composite en
• J00660023198: BRILLIANT COMPONEER are polymerised, prefabricated, highly filled, submicron hybrid composite en
• J00660023197: BRILLIANT COMPONEER are polymerised, prefabricated, highly filled, submicron hybrid composite en
• J00660023194: BRILLIANT COMPONEER are polymerised, prefabricated, highly filled, submicron hybrid composite en
• J00660023147: BRILLIANT COMPONEER are polymerised, prefabricated, highly filled, submicron hybrid composite en
• J00660023146: BRILLIANT COMPONEER are polymerised, prefabricated, highly filled, submicron hybrid composite en
• J00660023127: BRILLIANT COMPONEER are polymerised, prefabricated, highly filled, submicron hybrid composite en
• J00660023126: BRILLIANT COMPONEER are polymerised, prefabricated, highly filled, submicron hybrid composite en
• J00660023125: BRILLIANT COMPONEER are polymerised, prefabricated, highly filled, submicron hybrid composite en
• J00660023124: BRILLIANT COMPONEER are polymerised, prefabricated, highly filled, submicron hybrid composite en
• J00660023123: BRILLIANT COMPONEER are polymerised, prefabricated, highly filled, submicron hybrid composite en
• J00660023122: BRILLIANT COMPONEER are polymerised, prefabricated, highly filled, submicron hybrid composite en
• J00660023196: BRILLIANT COMPONEER are polymerised, prefabricated, highly filled, submicron hybrid composite en
• J00660023195: BRILLIANT COMPONEER are polymerised, prefabricated, highly filled, submicron hybrid composite en
• J00660023191: BRILLIANT COMPONEER are polymerised, prefabricated, highly filled, submicron hybrid composite en
• J00660023190: BRILLIANT COMPONEER are polymerised, prefabricated, highly filled, submicron hybrid composite en
• J00660023189: BRILLIANT COMPONEER are polymerised, prefabricated, highly filled, submicron hybrid composite en
• J00660023188: BRILLIANT COMPONEER are polymerised, prefabricated, highly filled, submicron hybrid composite en
• J00660023180: BRILLIANT COMPONEER are polymerised, prefabricated, highly filled, submicron hybrid composite en
• J00660023179: BRILLIANT COMPONEER are polymerised, prefabricated, highly filled, submicron hybrid composite en
• J00660023178: BRILLIANT COMPONEER are polymerised, prefabricated, highly filled, submicron hybrid composite en
• J00660023177: BRILLIANT COMPONEER are polymerised, prefabricated, highly filled, submicron hybrid composite en
• J00660023169: BRILLIANT COMPONEER are polymerised, prefabricated, highly filled, submicron hybrid composite en
• J00660023168: BRILLIANT COMPONEER are polymerised, prefabricated, highly filled, submicron hybrid composite en