NobelPearl Temporary Abutment Inter-X RP 300714

GUDID 07640161393202

Prosthetics

Dentalpoint AG

Dental implant suprastructure, temporary, preformed, single-use

• Primary Device ID: 07640161393202
• NIH Device Record Key: de41e347-ef00-4a67-9cda-46c25ad4431d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NobelPearl Temporary Abutment Inter-X RP
• Version Model Number: 300714
• Catalog Number: 300714
• 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: 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: +41443883630
• Email: pascal.wettstein@zeramex.com

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	07640161393202 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180184

FDA Product Code

• NHA: ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS

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: 2018-12-31
• Device Publish Date: 2018-11-30

Devices Manufactured by Dentalpoint AG

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• 07640161393776 - ZERAMEX®XT Rescue-Shell XT WIDE: 2024-05-15 ZERAMEX®XT Rescue-Shell XT WIDE
• 07640161395077 - ZERAMEX®XT Rescue-Shell XT SMALL: 2024-05-15 ZERAMEX®XT Rescue-Shell XT SMALL
• 07640161396401 - CERALOG PL Implant, Ø 3.8 L 9: 2024-05-07 Dental Implant
• 07640161396432 - CERALOG PL Implant, Ø 3.8 L 11: 2024-05-07 Dental Implant
• 07640161396449 - CERALOG PL Implant, Ø 3.8 L 13: 2024-05-07 Dental Implant
• 07640161396456 - CERALOG PL Implant, Ø 4.3 L 9: 2024-05-07 Dental Implant
• 07640161396463 - CERALOG PL Implant,Ø 4.3 L 11: 2024-05-07 Dental Implant