Zerion Alpha, Zerion Beta 010.0002

GUDID 07630031701305

zerion HSC zirconium oxide ceramic 2 units bridge framework

Institut Straumann AG

Dental bridge, ceramic

• Primary Device ID: 07630031701305
• NIH Device Record Key: 4485b44c-ca3e-4fd6-b5f6-ca22f18102a8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Zerion Alpha, Zerion Beta
• Version Model Number: Bridges (tooth borne)
• Catalog Number: 010.0002
• Company DUNS: 483599259
• Company Name: Institut Straumann AG
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: false
• Serial Number: true
• 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: +1(800)448-8168
• Email: info.usa@straumann.com
• Phone: +1(800)448-8168
• Email: info.usa@straumann.com
• Phone: +1(800)448-8168
• Email: info.usa@straumann.com
• Phone: +1(800)448-8168
• Email: info.usa@straumann.com
• Phone: +1(800)448-8168
• Email: info.usa@straumann.com
• Phone: +1(800)448-8168
• Email: info.usa@straumann.com
• Phone: +1(800)448-8168
• Email: info.usa@straumann.com
• Phone: +1(800)448-8168
• Email: info.usa@straumann.com
• Phone: +1(800)448-8168
• Email: info.usa@straumann.com
• Phone: +1(800)448-8168
• Email: info.usa@straumann.com
• Phone: +1(800)448-8168
• Email: info.usa@straumann.com
• Phone: +1(800)448-8168
• Email: info.usa@straumann.com
• Phone: +1(800)448-8168
• Email: info.usa@straumann.com
• Phone: +1(800)448-8168
• Email: info.usa@straumann.com
• Phone: +1(800)448-8168
• Email: info.usa@straumann.com
• Phone: +1(800)448-8168
• Email: info.usa@straumann.com
• Phone: +1(800)448-8168
• Email: info.usa@straumann.com
• Phone: +1(800)448-8168
• Email: info.usa@straumann.com
• Phone: +1(800)448-8168
• Email: info.usa@straumann.com
• Phone: +1(800)448-8168
• Email: info.usa@straumann.com
• Phone: +1(800)448-8168
• Email: info.usa@straumann.com
• Phone: +1(800)448-8168
• Email: info.usa@straumann.com
• Phone: +1(800)448-8168
• Email: info.usa@straumann.com
• Phone: +1(800)448-8168
• Email: info.usa@straumann.com
• Phone: +1(800)448-8168
• Email: info.usa@straumann.com
• Phone: +1(800)448-8168
• Email: info.usa@straumann.com
• Phone: +1(800)448-8168
• Email: info.usa@straumann.com
• Phone: +1(800)448-8168
• Email: info.usa@straumann.com
• Phone: +1(800)448-8168
• Email: info.usa@straumann.com
• Phone: +1(800)448-8168
• Email: info.usa@straumann.com
• Phone: +1(800)448-8168
• Email: info.usa@straumann.com
• Phone: +1(800)448-8168
• Email: info.usa@straumann.com
• Phone: +1(800)448-8168
• Email: info.usa@straumann.com
• Phone: +1(800)448-8168
• Email: info.usa@straumann.com
• Phone: +1(800)448-8168
• Email: info.usa@straumann.com
• Phone: +1(800)448-8168
• Email: info.usa@straumann.com
• Phone: +1(800)448-8168
• Email: info.usa@straumann.com
• Phone: +1(800)448-8168
• Email: info.usa@straumann.com
• Phone: +1(800)448-8168
• Email: info.usa@straumann.com
• Phone: +1(800)448-8168
• Email: info.usa@straumann.com
• Phone: +1(800)448-8168
• Email: info.usa@straumann.com
• Phone: +1(800)448-8168
• Email: info.usa@straumann.com
• Phone: +1(800)448-8168
• Email: info.usa@straumann.com
• Phone: +1(800)448-8168
• Email: info.usa@straumann.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	07630031701305 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K061804

FDA Product Code

• EIH: POWDER, PORCELAIN

Sterilization

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

[07630031701305]

Moist Heat or Steam Sterilization

[07630031701305]

Moist Heat or Steam Sterilization

[07630031701305]

Moist Heat or Steam Sterilization

[07630031701305]

Moist Heat or Steam Sterilization

[07630031701305]

Moist Heat or Steam Sterilization

[07630031701305]

Moist Heat or Steam Sterilization

[07630031701305]

Moist Heat or Steam Sterilization

[07630031701305]

Moist Heat or Steam Sterilization

[07630031701305]

Moist Heat or Steam Sterilization

[07630031701305]

Moist Heat or Steam Sterilization

[07630031701305]

Moist Heat or Steam Sterilization

[07630031701305]

Moist Heat or Steam Sterilization

[07630031701305]

Moist Heat or Steam Sterilization

[07630031701305]

Moist Heat or Steam Sterilization

[07630031701305]

Moist Heat or Steam Sterilization

[07630031701305]

Moist Heat or Steam Sterilization

[07630031701305]

Moist Heat or Steam Sterilization

[07630031701305]

Moist Heat or Steam Sterilization

[07630031701305]

Moist Heat or Steam Sterilization

[07630031701305]

Moist Heat or Steam Sterilization

[07630031701305]

Moist Heat or Steam Sterilization

[07630031701305]

Moist Heat or Steam Sterilization

[07630031701305]

Moist Heat or Steam Sterilization

[07630031701305]

Moist Heat or Steam Sterilization

[07630031701305]

Moist Heat or Steam Sterilization

[07630031701305]

Moist Heat or Steam Sterilization

[07630031701305]

Moist Heat or Steam Sterilization

[07630031701305]

Moist Heat or Steam Sterilization

[07630031701305]

Moist Heat or Steam Sterilization

[07630031701305]

Moist Heat or Steam Sterilization

[07630031701305]

Moist Heat or Steam Sterilization

[07630031701305]

Moist Heat or Steam Sterilization

[07630031701305]

Moist Heat or Steam Sterilization

[07630031701305]

Moist Heat or Steam Sterilization

[07630031701305]

Moist Heat or Steam Sterilization

[07630031701305]

Moist Heat or Steam Sterilization

[07630031701305]

Moist Heat or Steam Sterilization

[07630031701305]

Moist Heat or Steam Sterilization

[07630031701305]

Moist Heat or Steam Sterilization

[07630031701305]

Moist Heat or Steam Sterilization

[07630031701305]

Moist Heat or Steam Sterilization

[07630031701305]

Moist Heat or Steam Sterilization

[07630031701305]

Moist Heat or Steam Sterilization

[07630031701305]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2022-05-09
• Device Publish Date: 2019-08-14

On-Brand Devices [Zerion Alpha, Zerion Beta]

• 07630031701299: zerion HSC zirconium oxide ceramic single unit
• 07630031701282: zerion HSC zirconium oxide ceramic primary crown
• 07630031701442: zerion HSC zirconium oxide ceramic 16 units bridge framework
• 07630031701435: zerion HSC zirconium oxide ceramic 15 units bridge framework
• 07630031701428: zerion HSC zirconium oxide ceramic 14 units bridge framework
• 07630031701411: zerion HSC zirconium oxide ceramic 13 units bridge framework
• 07630031701404: zerion HSC zirconium oxide ceramic 12 units bridge framework
• 07630031701398: zerion HSC zirconium oxide ceramic 11 units bridge framework
• 07630031701381: zerion HSC zirconium oxide ceramic 10 units bridge framework
• 07630031701374: zerion HSC zirconium oxide ceramic 9 units bridge framework
• 07630031701367: zerion HSC zirconium oxide ceramic 8 units bridge framework
• 07630031701350: zerion HSC zirconium oxide ceramic 7 units bridge framework
• 07630031701343: zerion HSC zirconium oxide ceramic 6 units bridge framework
• 07630031701336: zerion HSC zirconium oxide ceramic 5 units bridge framework
• 07630031701329: zerion HSC zirconium oxide ceramic 4 units bridge framework
• 07630031701312: zerion HSC zirconium oxide ceramic 3 units bridge framework
• 07630031701305: zerion HSC zirconium oxide ceramic 2 units bridge framework