Straumann PrefGel 075.203W

GUDID 07630031730053

Straumann® PrefGel®, 5 x 0.6 ml (24% EDTA)

Institut Straumann AG

Dental root surface conditioner

• Primary Device ID: 07630031730053
• NIH Device Record Key: 22a296bf-e892-4246-96ef-8daa4178d9a0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Straumann PrefGel
• Version Model Number: PrefGel
• Catalog Number: 075.203W
• 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: true
• 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

Device Dimensions

• Total Volume: 0.6 Milliliter
• Total Volume: 0.6 Milliliter
• Total Volume: 0.6 Milliliter
• Total Volume: 0.6 Milliliter
• Total Volume: 0.6 Milliliter
• Total Volume: 0.6 Milliliter
• Total Volume: 0.6 Milliliter
• Total Volume: 0.6 Milliliter
• Total Volume: 0.6 Milliliter
• Total Volume: 0.6 Milliliter
• Total Volume: 0.6 Milliliter
• Total Volume: 0.6 Milliliter
• Total Volume: 0.6 Milliliter
• Total Volume: 0.6 Milliliter
• Total Volume: 0.6 Milliliter
• Total Volume: 0.6 Milliliter
• Total Volume: 0.6 Milliliter

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	07630031730053 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K063812

FDA Product Code

• KJJ: CLEANSER, ROOT CANAL

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-10-09
• Device Publish Date: 2023-09-30

Devices Manufactured by Institut Straumann AG

• 07630031776198 - NA: 2025-07-09 NT Impression Post Closed Tray, with 1 guide screw & 2 caps, non-engaging, TAN/POM
• 07630031742278 - Straumann TLX Implant System: 2025-06-18 TLX SP Implant, Ø 4.0mm NT, SLA® 8mm, Roxolid®
• 07630031742285 - Straumann TLX Implant System: 2025-06-18 TLX SP Implant, Ø 4.0mm NT, SLA® 10mm, Roxolid®
• 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®