PURE Ceramic Implants 031.002S

GUDID 07630031713797

Straumann® PURE Ceramic Implant Monotype, Ø 3.3mm ND, ZLA 10mm, AH 4mm, ZrO2

Institut Straumann AG

Screw endosteal dental implant, one-piece

• Primary Device ID: 07630031713797
• NIH Device Record Key: fdaff8db-5254-4862-8dd7-0cddfb97983f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PURE Ceramic Implants
• Version Model Number: 1
• Catalog Number: 031.002S
• 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: 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: +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 Dimensions

• Length: 10 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 3.3 Millimeter
• Length: 10 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 3.3 Millimeter
• Length: 10 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 3.3 Millimeter
• Length: 10 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 3.3 Millimeter
• Length: 10 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 3.3 Millimeter
• Length: 10 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 3.3 Millimeter
• Length: 10 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 3.3 Millimeter
• Length: 10 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 3.3 Millimeter
• Length: 10 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 3.3 Millimeter
• Length: 10 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 3.3 Millimeter
• Length: 10 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 3.3 Millimeter
• Length: 10 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 3.3 Millimeter
• Length: 10 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 3.3 Millimeter
• Length: 10 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 3.3 Millimeter
• Length: 10 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 3.3 Millimeter
• Length: 10 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 3.3 Millimeter
• Length: 10 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 3.3 Millimeter
• Length: 10 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 3.3 Millimeter
• Length: 10 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 3.3 Millimeter

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight

Device Identifiers

Device Issuing Agency	Device ID
GS1	07630031713797 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151328

FDA Product Code

• DZE: IMPLANT, ENDOSSEOUS, ROOT-FORM

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: 2018-07-06
• Device Publish Date: 2016-01-20

On-Brand Devices [PURE Ceramic Implants]

• 07630031714268: RD Protective Cap, AH 5.5mm, PEEK
• 07630031714251: RD Protective Cap, AH 4mm, PEEK
• 07630031714244: ND Protective Cap, AH 5.5 mm, PEEK
• 07630031714237: ND Protective Cap, AH 4.0 mm, PEEK
• 07630031714220: RD Temporary Coping, for Bridge, PMMA
• 07630031714213: RD Temporary Coping, for Crown, PMMA
• 07630031714206: ND Temporary Coping, for bridge, PMMA
• 07630031714190: ND Temporary Coping, for crown, PMMA
• 07630031714015: Straumann® PURE Ceramic Implant Monotype, Ø 4.1mm RD, ZLA 14mm, AH 5.5mm, ZrO2
• 07630031713995: Straumann® PURE Ceramic Implant Monotype, Ø 4.1mm RD, ZLA 12mm, AH 5.5mm, ZrO2
• 07630031713971: Straumann® PURE Ceramic Implant Monotype, Ø 4.1mm RD, ZLA 10mm, AH 5.5mm, ZrO2
• 07630031713957: Straumann® PURE Ceramic Implant Monotype, Ø 4.1mm RD, ZLA 8mm, AH 5.5mm, ZrO2
• 07630031713933: Straumann® PURE Ceramic Implant Monotype, Ø 4.1mm RD, ZLA 14mm, AH 4mm, ZrO2
• 07630031713919: Straumann® PURE Ceramic Implant Monotype, Ø 4.1mm RD, ZLA 12mm, AH 4mm, ZrO2
• 07630031713896: Straumann® PURE Ceramic Implant Monotype, Ø 4.1mm RD, ZLA 10mm, AH 4mm, ZrO2
• 07630031713872: Straumann® PURE Ceramic Implant Monotype, Ø 4.1mm RD, ZLA 8mm, AH 4mm, ZrO2
• 07630031713858: Straumann® PURE Ceramic Implant Monotype, Ø 3.3mm ND, ZLA 14mm, AH 5.5mm, ZrO2
• 07630031713841: Straumann® PURE Ceramic Implant Monotype, Ø 3.3mm ND, ZLA 12mm, AH 5.5mm, ZrO2
• 07630031713834: Straumann® PURE Ceramic Implant Monotype, Ø 3.3mm ND, ZLA 10mm, AH 5.5mm, ZrO2
• 07630031713827: Straumann® PURE Ceramic Implant Monotype, Ø 3.3mm ND, ZLA 8mm, AH 5.5mm, ZrO2
• 07630031713810: Straumann® PURE Ceramic Implant Monotype, Ø 3.3mm ND, ZLA 14mm, AH 4mm, ZrO2
• 07630031713803: Straumann® PURE Ceramic Implant Monotype, Ø 3.3mm ND, ZLA 12mm, AH 4mm, ZrO2
• 07630031713797: Straumann® PURE Ceramic Implant Monotype, Ø 3.3mm ND, ZLA 10mm, AH 4mm, ZrO2
• 07630031713780: Straumann® PURE Ceramic Implant Monotype, Ø 3.3mm ND, ZLA 8mm, AH 4mm, ZrO2