SIMPLY ICONIC™ Implant 674708RP

GUDID 10841307125174

4.7mmD x 8mmL, 3.4mmD Platform

IMPLANT DIRECT SYBRON MANUFACTURING LLC

Dental implant system Dental implant system Dental implant system Dental implant system Dental implant system Dental implant system Dental implant system Dental implant system Dental implant system Dental implant system Dental implant system Dental implant system Dental implant system Dental implant system Dental implant system

• Primary Device ID: 10841307125174
• NIH Device Record Key: 101873b3-73a4-413a-88e4-e8e89ecafd5f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SIMPLY ICONIC™ Implant
• Version Model Number: 674708RP
• Catalog Number: 674708RP
• Company DUNS: 868856969
• Company Name: IMPLANT DIRECT SYBRON MANUFACTURING LLC
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• 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

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	10841307125174 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K201553

FDA Product Code

• DZE: Implant, Endosseous, Root-Form

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: 2021-05-10
• Device Publish Date: 2021-04-30

On-Brand Devices [SIMPLY ICONIC™ Implant]

• 10841307125976: 5.7mmD x 13mmL, 3.4mmD Platform
• 10841307125969: 4.7mmD x 16mmL, 3.4mmD Platform
• 10841307125952: 4.7mmD x 16mmL, 3.0mmD Platform
• 10841307125297: 5.7mmD x 11.5mmL, 3.4mmD Platform
• 10841307125280: 5.7mmD x 10mmL, 3.4mmD Platform
• 10841307125273: 5.7mmD x 8mmL, 3.4mmD Platform
• 10841307125266: 5.7mmD x 6mmL, 3.4mmD Platform
• 10841307125259: 5.2mmD x 13mmL, 3.4mmD Platform
• 10841307125242: 5.2mmD x 11.5mmL, 3.4mmD Platform
• 10841307125235: 5.2mmD x 10mmL, 3.4mmD Platform
• 10841307125228: 5.2mmD x 8mmL, 3.4mmD Platform
• 10841307125211: 5.2mmD x 6mmL, 3.4mmD Platform
• 10841307125204: 4.7mmD x 13mmL, 3.4mmD Platform
• 10841307125198: 4.7mmD x 11.5mmL, 3.4mmD Platform
• 10841307125181: 4.7mmD x 10mmL, 3.4mmD Platform
• 10841307125174: 4.7mmD x 8mmL, 3.4mmD Platform
• 10841307125167: 4.7mmD x 6mmL, 3.4mmD Platform
• 10841307125150: 4.7mmD x 13mmL, 3.0mmD Platform
• 10841307125143: 4.7mmD x 11.5mmL, 3.0mmD Platform
• 10841307125136: 4.7mmD x 10mmL, 3.0mmD Platform
• 10841307125129: 4.7mmD x 8mmL, 3.0mmD Platform
• 10841307125112: 4.7mmD x 6mmL, 3.0mmD Platform
• 10841307125105: 4.2mmD x 16mmL, 3.0mmD Platform
• 10841307125099: 4.2mmD x 13mmL, 3.0mmD Platform
• 10841307125082: 4.2mmD x 11.5mmL, 3.0mmD Platform
• 10841307125075: 4.2mmD x 10mmL, 3.0mmD Platform
• 10841307125068: 4.2mmD x 8mmL, 3.0mmD Platform
• 10841307125051: 4.2mmD x 6mmL, 3.0mmD Platform
• 10841307125044: 3.7mmD x 16mmL, 3.0mmD Platform
• 10841307125037: 3.7mmD x 13mmL, 3.0mmD Platform
• 10841307125020: 3.7mmD x 11.5mmL, 3.0mmD Platform
• 10841307125013: 3.7mmD x 10mmL, 3.0mmD Platform
• 10841307125006: 3.7mmD x 8mmL, 3.0mmD Platform
• 10841307124993: 3.7mmD x 6mmL, 3.0mmD Platform
• 10841307124986: 3.2mmD x 16mmL, 3.0mmD Platform
• 10841307124979: 3.2mmD x 13mmL, 3.0mmD Platform
• 10841307124962: 3.2mmD x 11.5mmL, 3.0mmD Platform
• 10841307124955: 3.2mmD x 10mmL, 3.0mmD Platform
• 10841307124948: 3.2mmD x 8mmL, 3.0mmD Platform