STRAUMANN DENTAL IMPLANT SYSTEM 021.2310

GUDID 07630031706461

Bone Level Implant D 3.3mm NC, SLActive® 10mm, Roxolid® Loxim™

Institut Straumann AG

Screw endosteal dental implant, two-piece

• Primary Device ID: 07630031706461
• NIH Device Record Key: 77d9f015-569b-4468-9d00-a2948ba53042
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: STRAUMANN DENTAL IMPLANT SYSTEM
• Version Model Number: 1
• Catalog Number: 021.2310
• 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: 10 Millimeter
• Outer Diameter: 3.3 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	07630031706461 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K083550

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 [STRAUMANN DENTAL IMPLANT SYSTEM]

• 07630031727602: Tapered Effect Implant, ø4.1mm, WN, SLActive, 14.0mm, Ti
• 07630031727596: Tapered Effect Implant, ø4.1mm, WN, SLActive, 12.0mm, Ti
• 07630031727589: Tapered Effect Implant, ø4.1mm, WN, SLActive, 10.0mm, Ti
• 07630031716613: Standard Plus Implant, D 3.3mm NN SLActive® 14mm, Ti
• 07630031716606: Standard Plus Implant, D 3.3mm NN SLActive® 12mm, Ti
• 07630031716590: Standard Plus Implant, D 3.3mm NN SLActive® 10mm, Ti
• 07630031716583: Standard Plus Implant D 3.3mm, NN, SLActive® 8mm, Ti
• 07630031716576: Tapered Effect Implant D 4.1mm RN, SLActive® 14mm, Ti
• 07630031716569: Tapered Effect Implant D 4.1mm RN, SLActive® 12mm, Ti
• 07630031716545: Tapered Effect Implant D 4.1mm RN, SLActive® 10mm, Ti
• 07630031716521: Tapered Effect Implant D 4.1mm RN, SLActive® 8mm, Ti
• 07630031716507: Tapered Effect Implant, D 3.3 mm, RN, SLActive 14 mm, Roxolid
• 07630031716491: Tapered Effect Implant, D 3.3 mm, RN, SLActive 12 mm, Roxolid
• 07630031716484: Tapered Effect Implant, D 3.3 mm, RN, SLActive 10 mm, Roxolid
• 07630031716477: Tapered Effect Implant, D 3.3 mm, RN, SLActive 8 mm, Roxolid
• 07630031716460: Tapered Effect Implant D 3.3mm RN, SLActive® 14mm, Ti
• 07630031716453: Tapered Effect Implant D 3.3mm RN, SLActive® 12mm, Ti
• 07630031716446: Tapered Effect Implant D 3.3mm RN, SLActive® 10mm, Ti
• 07630031716439: Tapered Effect Implant D 3.3mm RN, SLActive® 8mm, Ti
• 07630031716422: Tapered Effect Implant D 4.8mm WN, SLActive® 14mm, Ti
• 07630031716415: Tapered Effect Implant D 4.8mm WN, SLActive® 12mm, Ti
• 07630031716408: Tapered Effect Implant D 4.8mm WN, SLActive® 10mm, Ti
• 07630031716392: Standard Plus Implant D 4.8mm, WN, SLActive® 12mm, Ti
• 07630031716385: Standard Plus Implant D 4.8mm, WN, SLActive® 10mm, Ti
• 07630031716378: Standard Plus Implant D 4.8mm, WN, SLActive® 8mm, Ti
• 07630031716361: Standard Plus Implant D 4.8mm, WN, SLActive® 6mm, Ti
• 07630031716354: Standard Implant D 4.8mm, WN, SLActive® 12mm, Ti
• 07630031716347: Standard Implant D 4.8mm, WN, SLActive® 10mm, Ti
• 07630031716330: Standard Implant D 4.8mm, WN, SLActive® 8mm, Ti
• 07630031716323: Standard Implant D 4.8mm, WN, SLActive® 6mm, Ti
• 07630031715821: Tapered Effect Implant, D 3.3mm RN, SLActive® 14mm, Roxolid®, Loxim™
• 07630031715814: Tapered Effect Implant, D 3.3mm RN, SLActive® 12mm, Roxolid®, Loxim™
• 07630031715807: Tapered Effect Implant, D 3.3mm RN, SLActive® 10mm, Roxolid®, Loxim™
• 07630031715784: Standard Plus Implant, D 3.3mm RN, SLActive® 14mm, Roxolid®, Loxim™
• 07630031715777: Standard Plus Implant, D 3.3mm RN, SLActive® 12mm, Roxolid®, Loxim™
• 07630031715760: Standard Plus Implant, D 3.3mm RN, SLActive® 10mm, Roxolid®, Loxim™
• 07630031715746: Standard Implant, D 3.3mm RN, SLActive® 16mm, Roxolid®, Loxim™
• 07630031715739: Standard Implant, D 3.3mm RN, SLActive® 14mm, Roxolid®, Loxim™
• 07630031715722: Standard Implant, D 3.3mm RN, SLActive® 12mm, Roxolid®, Loxim™
• 07630031715715: Standard Implant, D 3.3mm RN, SLActive® 10mm, Roxolid®, Loxim™
• 07630031715708: Standard Implant, D 3.3mm RN, SLActive® 8mm, Roxolid®, Loxim™
• 07630031715692: Standard Plus Implant, D 3.3 mm, RN, SLActive 14 mm, Roxolid
• 07630031715685: Standard Plus Implant, D 3.3 mm, RN, SLActive 12 mm, Roxolid
• 07630031715661: Standard Plus Implant, D 3.3 mm, RN, SLActive 10 mm, Roxolid
• 07630031715647: Standard Plus Implant, D 3.3 mm, RN, SLActive 8 mm, Roxolid
• 07630031715623: Standard Implant, D 3.3 mm, RN, SLActive 16 mm, Roxolid
• 07630031715616: Standard Implant, D 3.3 mm, RN, SLActive 14 mm, Roxolid
• 07630031715609: Standard Implant, D 3.3 mm, RN, SLActive 12 mm, Roxolid
• 07630031715586: Standard Implant, D 3.3 mm, RN, SLActive 10 mm, Roxolid
• 07630031715562: Standard Implant, D 3.3 mm, RN, SLActive 8 mm, Roxolid