NobelPearl Tapered RP 4.2x14mm 300758

GUDID 07640161392939

Dental Implant

Dentalpoint AG

Dental implant system

• Primary Device ID: 07640161392939
• NIH Device Record Key: 36cedb2d-f7e0-415b-aa7f-5b7491d017c4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NobelPearl Tapered RP 4.2x14mm
• Version Model Number: 300758
• Catalog Number: 300758
• 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	07640161392939 [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 RP 4.2x14mm]

• 07640161392939: Dental Implant
• 07640161395145: Dental Implant