Pekkton Ivory 01060032

GUDID 07640166511526

0106 0032 Pekkton® ivory milling blank ø 95/24mm (compatible with Zirkonzahn®)

Cendres+Métaux SA

Dental prosthesis veneer resin

• Primary Device ID: 07640166511526
• NIH Device Record Key: 72a5029a-bbea-48db-a133-4b99c82251b5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pekkton Ivory
• Version Model Number: 01060032
• Catalog Number: 01060032
• Company DUNS: 487506230
• Company Name: Cendres+Métaux SA
• 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: true
• Expiration Date: false
• 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: +41583602000
• Email: info@cmsa.ch
• Phone: +41583602000
• Email: info@cmsa.ch
• Phone: +41583602000
• Email: info@cmsa.ch
• Phone: +41583602000
• Email: info@cmsa.ch
• Phone: +41583602000
• Email: info@cmsa.ch
• Phone: +41583602000
• Email: info@cmsa.ch
• Phone: +41583602000
• Email: info@cmsa.ch
• Phone: +41583602000
• Email: info@cmsa.ch
• Phone: +41583602000
• Email: info@cmsa.ch
• Phone: +41583602000
• Email: info@cmsa.ch
• Phone: +41583602000
• Email: info@cmsa.ch
• Phone: +41583602000
• Email: info@cmsa.ch
• Phone: +41583602000
• Email: info@cmsa.ch
• Phone: +41583602000
• Email: info@cmsa.ch
• Phone: +41583602000
• Email: info@cmsa.ch
• Phone: +41583602000
• Email: info@cmsa.ch
• Phone: +41583602000
• Email: info@cmsa.ch
• Phone: +41583602000
• Email: info@cmsa.ch
• Phone: +41583602000
• Email: info@cmsa.ch
• Phone: +41583602000
• Email: info@cmsa.ch
• Phone: +41583602000
• Email: info@cmsa.ch
• Phone: +41583602000
• Email: info@cmsa.ch
• Phone: +41583602000
• Email: info@cmsa.ch
• Phone: +41583602000
• Email: info@cmsa.ch
• Phone: +41583602000
• Email: info@cmsa.ch
• Phone: +41583602000
• Email: info@cmsa.ch
• Phone: +41583602000
• Email: info@cmsa.ch
• Phone: +41583602000
• Email: info@cmsa.ch
• Phone: +41583602000
• Email: info@cmsa.ch

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
• 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

• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight

Device Identifiers

Device Issuing Agency	Device ID
GS1	07640166511526 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170102

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: 2
• Public Version Date: 2018-12-03
• Device Publish Date: 2018-07-05

On-Brand Devices [Pekkton Ivory]

• 07640166511786: Pekkton ivory Press Blank Pekkton® ivory – press ingots / 10 p.
• 07640166511526: 0106 0032 Pekkton® ivory milling blank ø 95/24mm (compatible with Zirkonzahn®)
• 07640166511502: Pekkton® ivory milling blank ø 95/20mm (compatible with Zirkonzahn®)
• 07640166511496: Pekkton ivory milling blankPekkton® ivory milling blank ø 95/16mm (compatible with ZirkonzahnÂ
• 07640166511489: Pekkton® ivory milling blank ø 98.5/24mm (with steps)
• 07640166511472: Pekkton® ivory milling blank ø 98.5/20mm (with steps)
• 07640166511458: Pekkton® ivory milling blank ø 98.5/16mm (with steps)
• 07640166511793: Pekkton ivory Press Blank Pekkton® ivory – press ingots / 10 p.