Stage 1 Implant System RSR4116-3K

GUDID D768RSR41163K0

Implant

KEYSTONE DENTAL, INC.

Screw endosteal dental implant, two-piece

• Primary Device ID: D768RSR41163K0
• NIH Device Record Key: 86b98a02-9351-4619-870a-93040be5a850
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Stage 1 Implant System
• Version Model Number: RSR4116-3K
• Catalog Number: RSR4116-3K
• Company DUNS: 787471015
• Company Name: KEYSTONE DENTAL, INC.
• 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: 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(781)328-3515
• Email: cyoung@keystonedental.com
• Phone: +1(866)902-9272
• Email: info@keystonedental.com
• Phone: +1(866)902-9272
• Email: info@keystonedental.com
• Phone: +1(866)902-9272
• Email: info@keystonedental.com
• Phone: +1(866)902-9272
• Email: info@keystonedental.com
• Phone: +1(866)902-9272
• Email: info@keystonedental.com
• Phone: +1(866)902-9272
• Email: info@keystonedental.com
• Phone: +1(866)902-9272
• Email: info@keystonedental.com
• Phone: +1(866)902-9272
• Email: info@keystonedental.com
• Phone: +1(866)902-9272
• Email: info@keystonedental.com
• Phone: +1(866)902-9272
• Email: info@keystonedental.com
• Phone: +1(866)902-9272
• Email: info@keystonedental.com
• Phone: +1(866)902-9272
• Email: info@keystonedental.com
• Phone: +1(866)902-9272
• Email: info@keystonedental.com
• Phone: +1(866)902-9272
• Email: info@keystonedental.com
• Phone: +1(866)902-9272
• Email: info@keystonedental.com
• Phone: +1(866)902-9272
• Email: info@keystonedental.com

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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D768RSR41163K0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K003226

FDA Product Code

• DZE: IMPLANT, ENDOSSEOUS, ROOT-FORM

Sterilization

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

[D768RSR41163K0]

Radiation Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-01-29

On-Brand Devices [Stage 1 Implant System]

• D768RSW63102K0: Implant
• D768RSW63082K0: Implant
• D768RSW55142K0: Implant
• D768RSW55123K0: Implant
• D768RSW55122K0: Implant
• D768RSW55103K0: Implant
• D768RSW55102K0: Implant
• D768RSW55083K0: Implant
• D768RSW55082K0: Implant
• D768RSW48142K0: Implant
• D768RSW48123K0: Implant
• D768RSW48122K0: Implant
• D768RSW48103K0: Implant
• D768RSW48102K0: Implant
• D768RSW48083K0: Implant
• D768RSW48082K0: Implant
• D768RSR48162K0: Implant
• D768RSR48143K0: Implant
• D768RSR48142K0: Implant
• D768RSR48123K0: Implant
• D768RSR48122K0: Implant
• D768RSR48103K0: Implant
• D768RSR48102K0: Implant
• D768RSR48083K0: Implant
• D768RSR48082K0: Implant
• D768RSR41163K0: Implant
• D768RSR41162K0: Implant
• D768RSR41143K0: Implant
• D768RSR41142K0: Implant
• D768RSR41123K0: Implant
• D768RSR41122K0: Implant
• D768RSR41103K0: Implant
• D768RSR41102K0: Implant
• D768RSR41083K0: Implant
• D768RSR41082K0: Implant
• D768RSR33143K0: Implant
• D768RSR33142K0: Implant
• D768RSR33123K0: Implant
• D768RSR33122K0: Implant
• D768RSR33103K0: Implant
• D768RSR33102K0: Implant
• D768RSR33083K0: Implant
• D768RSR33082K0: Implant