ZERAMEX® P35504

GUDID 07640161390225

ZERAMEX®P Gingivaformer SN, 4mm

Dentalpoint AG

Dental implant suprastructure, temporary, preformed, single-use

• Primary Device ID: 07640161390225
• NIH Device Record Key: cec6fc1f-8186-4fd0-ba68-638098ab880b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ZERAMEX®
• Version Model Number: P35504
• Catalog Number: P35504
• 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: false
• 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: +41(0)443883636
• Email: info@zeramex.com
• Phone: +41(0)443883636
• Email: info@zeramex.com
• Phone: +41(0)443883636
• Email: info@zeramex.com
• Phone: +41(0)443883636
• Email: info@zeramex.com
• Phone: +41(0)443883636
• Email: info@zeramex.com
• Phone: +41(0)443883636
• Email: info@zeramex.com
• Phone: +41(0)443883636
• Email: info@zeramex.com
• Phone: +41(0)443883636
• Email: info@zeramex.com
• Phone: +41(0)443883636
• Email: info@zeramex.com
• Phone: +41(0)443883636
• Email: info@zeramex.com

Device Dimensions

• Height: 4 Millimeter
• Outer Diameter: 5 Millimeter
• Height: 4 Millimeter
• Outer Diameter: 5 Millimeter
• Height: 4 Millimeter
• Outer Diameter: 5 Millimeter
• Height: 4 Millimeter
• Outer Diameter: 5 Millimeter
• Height: 4 Millimeter
• Outer Diameter: 5 Millimeter
• Height: 4 Millimeter
• Outer Diameter: 5 Millimeter
• Height: 4 Millimeter
• Outer Diameter: 5 Millimeter
• Height: 4 Millimeter
• Outer Diameter: 5 Millimeter
• Height: 4 Millimeter
• Outer Diameter: 5 Millimeter
• Height: 4 Millimeter
• Outer Diameter: 5 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	07640161390225 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152385

FDA Product Code

• NHA: ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-12-07
• Device Publish Date: 2017-04-17

On-Brand Devices [ZERAMEX®]

• 07640161391734: ZERAMEX®P Closure Screw RN
• 07640161390751: ZERAMEX®P Provisorium Screw RN
• 07640161390744: ZERAMEX®P Provisorium Screw SN
• 07640161390645: ZERAMEX® ZERALOCK™ Locator® 5mm RN
• 07640161390638: ZERAMEX® ZERALOCK™ Locator® 3mm RN
• 07640161390621: ZERAMEX® ZERALOCK™ Locator® 2mm RN
• 07640161390614: ZERAMEX® ZERALOCK™ Locator® 5mm SN
• 07640161390607: ZERAMEX® ZERALOCK™ Locator® 3mm SN
• 07640161390591: ZERAMEX® ZERALOCK™ Locator® 2mm SN
• 07640161390584: ZERAMEX® ZERALOCK™ Abutment angular 15°
• 07640161390577: ZERAMEX® ZERALOCK™ Abutment RN straight
• 07640161390560: ZERAMEX® ZERALOCK™ Abutment SN angular 15°
• 07640161390553: ZERAMEX® ZERALOCK™ Abutment SN straight
• 07640161390331: ZERAMEX®P Provisorium RN (inkl. Screw)
• 07640161390294: ZERAMEX®P Gingivaformer RN, 4mm
• 07640161390287: ZERAMEX®P Gingivaformer RN, 3mm
• 07640161390270: ZERAMEX®P Healing Cap RN
• 07640161390263: ZERAMEX®P Provisorium SN (inkl. Screw)
• 07640161390225: ZERAMEX®P Gingivaformer SN, 4mm
• 07640161390218: ZERAMEX®P Gingivaformer SN, 3mm
• 07640161390201: ZERAMEX®P Healing Cap SN
• 07640161390195: ZERAMEX®P Implant Ø4.8x12mm RN (incl. Healing Cap)
• 07640161390188: ZERAMEX®P Implant Ø4.8x10mm RN (incl. Healing Cap)
• 07640161390171: ZERAMEX®P Implant Ø4.8x8mm RN (incl. Healing Cap)
• 07640161390164: ZERAMEX®P Implant Ø4.1x12mm RN (incl. Healing Cap)
• 07640161390157: ZERAMEX®P Implant Ø4.1x10mm RN (incl. Healing Cap)
• 07640161390140: ZERAMEX®P Implant Ø4.1x8mm RN (incl. Healing Cap)
• 07640161390133: ZERAMEX®P Implant Ø3.3x12mm SN (incl. Healing Cap)
• 07640161390126: ZERAMEX®P Implant Ø3.3x10mm SN (incl. Healing Cap)
• 07640161390119: ZERAMEX®P Implant Ø3.3x8mm SN (incl. Healing Cap)
• 07640161390102: ZERAMEX®P VICARBO Screw RN Angular
• 07640161390096: ZERAMEX®P VICARBO Screw RN Straight
• 07640161390089: ZERAMEX®P VICARBO Screw SN Angular
• 07640161390072: ZERAMEX®P VICARBO Screw SN Straight
• 07640161390065: ZERAMEX®P Abutment RN angular 15°, 1mm (incl. Screw)
• 07640161390058: ZERAMEX®P Abutment RN straight, 2mm (incl. Screw)
• 07640161390041: ZERAMEX®P Abutment RN straight, 1mm (incl. Screw)
• 07640161390034: ZERAMEX®P Abutment SN angular 15°, 1mm (incl. Screw)
• 07640161390027: ZERAMEX®P Abutment SN straight, 2mm (incl. Screw)
• 07640161390010: ZERAMEX®P Abutment SN straight, 1mm (incl. Screw)