NobelPearl Tapered WP 5.5x8mm 300759

GUDID 07640161392946

Dental Implant

Dentalpoint AG

Dental implant system

• Primary Device ID: 07640161392946
• NIH Device Record Key: 8ac35cb6-d65c-479e-ac81-f768a5975466
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NobelPearl Tapered WP 5.5x8mm
• Version Model Number: 300759
• Catalog Number: 300759
• Company DUNS: 483229493
• Company Name: Dentalpoint AG
• 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: true
• 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: +41443883630
• Email: pascal.wettstein@zeramex.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep dry, Keep out of sunlight
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	07640161392946 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180184

FDA Product Code

• DZE: IMPLANT, ENDOSSEOUS, ROOT-FORM

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-12-31
• Device Publish Date: 2018-11-30

On-Brand Devices [NobelPearl Tapered WP 5.5x8mm]

• 07640161392946: Dental Implant
• 07640161395152: Dental Implant