ZERAMEX® SB Healing Cap SB35500

GUDID 07640161393998

ZERAMEX® SB Healing Cap

Dentalpoint AG

Dental implant suprastructure, temporary, preformed, single-use

• Primary Device ID: 07640161393998
• NIH Device Record Key: 3400b1ef-0dee-4a80-8152-18c13f9161b2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ZERAMEX® SB Healing Cap
• Version Model Number: SB35500
• Catalog Number: SB35500
• Company DUNS: 483229493
• Company Name: Dentalpoint 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	07640161393998 [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: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-10-21
• Device Publish Date: 2020-10-13

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