ZERAMEX® SB Gingivaformer, 4mm SB35504

GUDID 07640161394223

ZERAMEX® SB Gingivaformer, 4mm

Dentalpoint AG

Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use

• Primary Device ID: 07640161394223
• NIH Device Record Key: fa93107d-9155-4185-abe7-91a5f4f8550d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ZERAMEX® SB Gingivaformer, 4mm
• Version Model Number: SB35504
• Catalog Number: SB35504
• 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	07640161394223 [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

Devices Manufactured by Dentalpoint AG

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• 07640161397262 - NobelPearl™ Abutment Screw Retrieval Kit: 2023-11-09
• 07640161397231 - NobelPearl™ Tapered Surgery Kit: 2023-11-02 Tools
• 07640161397248 - NobelPearl™ Prosthetic Kit Inter-X: 2023-11-02 Tools
• 07640161397279 - ZERAMEX XT Rescue Instrument 28mm: 2023-11-02 Tools
• 07640161394810 - NobelPearl™ Position Locator Inter-X NP: 2023-06-08 Accessories
• 07640161396302 - NobelPearl Tapered Surgery Kit Box: 2023-02-16 NobelPearl Tapered Surgery Kit Plate
• 07640161397224 - Docklocs Abutment Torque Wrench Driver: 2023-02-16 Docklocs® Abutment Torque Wrench Driver