STRAUMANN ORTHOSYSTEM 048.079

GUDID 07630031722713

Healing cap, palatal implant, D 4.8mm, H 3.5mm, PEEK

Institut Straumann AG

Dental implant suprastructure, temporary, preformed, single-use

• Primary Device ID: 07630031722713
• NIH Device Record Key: d5182a00-47e0-45f4-815e-ad3a81c63bf3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: STRAUMANN ORTHOSYSTEM
• Version Model Number: Palatal-System
• Catalog Number: 048.079
• Company DUNS: 483599259
• Company Name: Institut Straumann 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: +1(800)448-8168
• Email: info.usa@straumann.com

Device Dimensions

• Length: 3.5 Millimeter
• Length: 3.5 Millimeter

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	07630031722713 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K060062

FDA Product Code

• OAT: Implant, endosseous, orthodontic

Sterilization

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

[07630031722713]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-04-04
• Device Publish Date: 2015-09-24

On-Brand Devices [STRAUMANN ORTHOSYSTEM]

• 07630031722713: Healing cap, palatal implant, D 4.8mm, H 3.5mm, PEEK
• 07630031722706: Cap with transpalatal arch, palatal implant, D 4.8mm, H 5.5mm, stainless steel
• 07630031722690: Cap with transpalatal arch, palatal implant, D 4.8mm, H 3.5mm, stainless steel
• 07630031722683: Cap, palatal implant, D 4.8mm, H 5.5mm, stainless steel
• 07630031722676: Cap, palatal implant, D 4.8mm, H 3.5mm, stainless steel
• 07630031718174: Palatal Implant D 4.8 mm SLA 4.2 mm, Ti
• 07630031718167: Palatal Implant D 4.1 mm SLA 4.2 mm, Ti