TL 04.1MM RN,S, SLACTIVE TIZR 6, 8, 10, 12, 14, 16MM DENTAL IMPLANTS 033.531G

GUDID 07630031715845

Standard Implant, D 4.1 RN, SLActive® 8mm, Roxolid®, guided

Institut Straumann AG

Screw endosteal dental implant, two-piece

• Primary Device ID: 07630031715845
• NIH Device Record Key: ef82bcb3-5879-466c-b8c2-07c3b59737f4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TL 04.1MM RN,S, SLACTIVE TIZR 6, 8, 10, 12, 14, 16MM DENTAL IMPLANTS
• Version Model Number: SLActive Roxolid TL
• Catalog Number: 033.531G
• 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

• Outer Diameter: 4.1 Millimeter
• Outer Diameter: 4.1 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	07630031715845 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K122855

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: 4
• Public Version Date: 2019-04-04
• Device Publish Date: 2015-09-24

On-Brand Devices [TL 04.1MM RN,S, SLACTIVE TIZR 6, 8, 10, 12, 14, 16MM DENTAL IMPLANTS]

• 07630031716095: Standard Implant, D 4.8mm RN, SLActive® 10mm, Roxolid®, Loxim™
• 07630031716088: Standard Implant, D 4.8mm RN, SLActive® 8mm, Roxolid®, Loxim™
• 07630031716071: Standard Implant, D 4.8mm RN, SLActive® 6mm, Roxolid®, Loxim™
• 07630031716064: Tapered Effect Implant, D 4.1mm RN, SLActive® 14mm, Roxolid®, Loxim™
• 07630031716057: Tapered Effect Implant, D 4.1mm RN, SLActive® 12mm, Roxolid®, Loxim™
• 07630031716040: Tapered Effect Implant, D 4.1 RN, SLActive® 12mm, Roxolid®, guided
• 07630031716033: Tapered Effect Implant, D 4.1mm RN, SLActive® 10mm, Roxolid®, Loxim™
• 07630031716026: Tapered Effect Implant, D 4.1 RN, SLActive® 10mm, Roxolid®, guided
• 07630031716019: Tapered Effect Implant, D 4.1mm RN, SLActive® 8mm, Roxolid®, Loxim™
• 07630031716002: Tapered Effect Implant, D 4.1 RN, SLActive® 8mm, Roxolid®, guided
• 07630031715999: Standard Plus Implant, D 4.1mm RN, SLActive® 14mm, Roxolid®, Loxim™
• 07630031715982: Standard Plus Implant, D 4.1mm RN, SLActive® 12mm, Roxolid®, Loxim™
• 07630031715975: Standard Plus Implant, D 4.1 RN, SLActive® 12mm, Roxolid®, guided
• 07630031715968: Standard Plus Implant, D 4.1mm RN, SLActive® 10mm, Roxolid®, Loxim™
• 07630031715951: Standard Plus Implant, D 4.1 RN, SLActive® 10mm, Roxolid®, guided
• 07630031715937: Standard Plus Implant, D 4.1 RN, SLActive® 8mm, Roxolid®, guided
• 07630031715913: Standard Implant, D 4.1mm RN, SLActive® 16mm, Roxolid®, Loxim™
• 07630031715906: Standard Implant, D 4.1mm RN, SLActive® 14mm, Roxolid®, Loxim™
• 07630031715890: Standard Implant, D 4.1mm RN, SLActive® 12mm, Roxolid®, Loxim™
• 07630031715883: Standard Implant, D 4.1 RN, SLActive® 12mm, Roxolid®, guided
• 07630031715876: Standard Implant, D 4.1mm RN, SLActive® 10mm, Roxolid®, Loxim™
• 07630031715869: Standard Implant, D 4.1 RN, SLActive® 10mm, Roxolid®, guided
• 07630031715852: Standard Implant, D 4.1mm RN, SLActive® 8mm, Roxolid®, Loxim™
• 07630031715845: Standard Implant, D 4.1 RN, SLActive® 8mm, Roxolid®, guided