STRAUMANN TIBRUSH 070.005

GUDID 07630031726780

Straumann® TiBrush, titanium, stainless steel

Institut Straumann AG

Dental implant debridement brush

• Primary Device ID: 07630031726780
• NIH Device Record Key: 29f6aa48-3470-4d67-9150-130178e9e299
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: STRAUMANN TIBRUSH
• Version Model Number: 1
• Catalog Number: 070.005
• 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
• 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	07630031726780 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K111724

FDA Product Code

• ELB: SCALER, ROTARY

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: 2016-10-20

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• 07630031703064 - Base metal alloy: 2025-06-16 ticon Titanium primary crown
• 07630031742261 - Straumann TLX Implant System: 2025-06-16 TLX SP Implant, Ø 4.0mm NT, SLA® 6mm, Roxolid®
• 07630031742292 - Straumann TLX Implant System: 2025-06-16 TLX SP Implant, Ø 4.0mm NT, SLA® 12mm, Roxolid®
• 07630031742308 - Straumann TLX Implant System: 2025-06-16 TLX SP Implant, Ø 4.0mm NT, SLA® 14mm, Roxolid®
• 07630031742315 - Straumann TLX Implant System: 2025-06-16 TLX SP Implant, Ø 4.0mm NT, SLA® 16mm, Roxolid®
• 07630031742322 - Straumann TLX Implant System: 2025-06-16 TLX SP Implant, Ø 4.0mm NT, SLA® 18mm, Roxolid®