TL 04.1MM RN,S, SLACTIVE TIZR 6, 8, 10, 12, 14, 16 033.591S

GUDID 07630031700902

Standard Plus Implant, D 4.8mm RN, SLActive® 8mm, Roxolid®, Loxim™

Institut Straumann AG

Screw endosteal dental implant, two-piece

• Primary Device ID: 07630031700902
• NIH Device Record Key: 8179ab2f-f98a-499d-bba7-79ac3b6f9da1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TL 04.1MM RN,S, SLACTIVE TIZR 6, 8, 10, 12, 14, 16
• Version Model Number: 1
• Catalog Number: 033.591S
• 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: 4.8 Millimeter
• Length: 8 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	07630031700902 [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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-09-24

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

• 07630031716316: Tapered Effect Implant, D 4.8mm WN, SLActive® 14mm, Roxolid®, Loxim™
• 07630031716309: Tapered Effect Implant, D 4.8mm WN, SLActive® 12mm, Roxolid®, Loxim™
• 07630031716293: Tapered Effect Implant, D 4.8mm WN, SLActive® 10mm, Roxolid®, Loxim™
• 07630031716279: Standard Plus Implant, D 4.8mm WN, SLActive® 12mm, Roxolid®, Loxim™
• 07630031716262: Standard Plus Implant, D 4.8mm WN, SLActive® 10mm, Roxolid®, Loxim™
• 07630031716255: Standard Plus Implant, D 4.8mm WN, SLActive® 8mm, Roxolid®, Loxim™
• 07630031716248: Standard Plus Implant, D 4.8mm WN, SLActive® 6mm, Roxolid®, Loxim™
• 07630031716231: Standard Implant, D 4.8mm WN, SLActive® 12mm, Roxolid®, Loxim™
• 07630031716224: Standard Implant, D 4.8mm WN, SLActive® 10mm, Roxolid®, Loxim™
• 07630031716217: Standard Implant, D 4.8mm WN, SLActive® 8mm, Roxolid®, Loxim™
• 07630031716200: Standard Implant, D 4.8mm WN, SLActive® 6mm, Roxolid®, Loxim™
• 07630031716194: Standard Plus Implant, D 4.8mm RN, SLActive® 14mm, Roxolid®, Loxim™
• 07630031716187: Standard Plus Implant, D 4.8mm RN, SLActive® 12mm, Roxolid®, Loxim™
• 07630031716170: Standard Plus Implant, D 4.8 RN, SLActive® 12mm, Roxolid®, guided
• 07630031716163: Standard Plus Implant, D 4.8mm RN, SLActive® 10mm, Roxolid®, Loxim™
• 07630031716156: Standard Plus Implant, D 4.8 RN, SLActive® 10mm, Roxolid®, guided
• 07630031716132: Standard Plus Implant, D 4.8 RN, SLActive® 8mm, Roxolid®, guided
• 07630031716118: Standard Implant, D 4.8mm RN, SLActive® 14mm, Roxolid®, Loxim™
• 07630031716101: Standard Implant, D 4.8mm RN, SLActive® 12mm, Roxolid®, Loxim™
• 07630031715838: Standard Implant, D 4.1mm RN, SLActive® 6mm, Roxolid®, Loxim™
• 07630031700902: Standard Plus Implant, D 4.8mm RN, SLActive® 8mm, Roxolid®, Loxim™
• 07630031700896: Standard Plus Implant, D 4.8mm RN, SLActive® 6mm, Roxolid®, Loxim™
• 07630031700889: Standard Plus Implant, D 4.1mm RN, SLActive® 8mm, Roxolid®, Loxim™
• 07630031700872: Standard Plus Implant, D 4.1mm RN, SLActive® 6mm, Roxolid®, Loxim™