ZERAMEX® RB Gingivaformer, 3mm RB36503

GUDID 07640161392182

Prosthetics

Dentalpoint AG

Dental implant suprastructure, temporary, preformed, single-use

• Primary Device ID: 07640161392182
• NIH Device Record Key: 91c77f76-604f-4920-ab10-ffcd50435071
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ZERAMEX® RB Gingivaformer, 3mm
• Version Model Number: RB36503
• Catalog Number: RB36503
• 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

• 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	07640161392182 [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: 2018-12-31
• Device Publish Date: 2018-11-30

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