Genesis G71221

GUDID D768G712210

Esth Con Abutment

KEYSTONE DENTAL, INC.

Dental implant suprastructure, permanent, preformed

• Primary Device ID: D768G712210
• NIH Device Record Key: d620bcc2-ffa5-4747-a858-bdd402e44b02
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Genesis
• Version Model Number: G71221
• Catalog Number: G71221
• 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	D768G712210 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K101545

FDA Product Code

• NHA: ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS

Sterilization

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

[D768G712210]

Radiation Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-11-08
• Device Publish Date: 2016-02-04

On-Brand Devices [Genesis]

• D768K156950: Ratchet
• D768G716130: Quad Driver
• D768G716120: Quad Driver
• D768G716110: Quad Driver
• D768G716100: Quad Driver
• D768G716090: Quad Driver
• D768G716080: Quad Driver
• D768G715480: Abutment Driver
• D768G715470: Abutment Driver
• D768G715450: Seating Tool
• D768G715250: Locator Driver
• D768G715240: Locator Tool
• D768G310460: Tap
• D768G310450: Tap
• D768G310420: Depth Gauge
• D768G310410: Depth Gauge
• D768G310400: Depth Gauge
• D768G310390: Depth Gauge
• D768G310380: Depth Gauge
• D768G310370: Depth Gauge
• D768G310360: Depth Gauge
• D768G310350: Depth Gauge
• D768G310340: Depth Gauge
• D768G310330: Depth Gauge
• D768G310320: Depth Gauge
• D768G310310: Depth Gauge
• D768G310300: Drill
• D768G310290: Drill
• D768G310280: Drill
• D768G310270: Drill
• D768G310260: Drill
• D768G310250: Drill
• D768G310240: Drill
• D768G310230: Drill
• D768G310220: Drill
• D768G310210: Drill
• D768G310200: Drill
• D768G310190: Drill
• D768G310180: Drill
• D768G310170: Drill
• D768G310160: Drill
• D768G310150: Drill
• D768G310140: Drill
• D768G310130: Drill
• D768G310120: Drill
• D768G310110: Drill
• D768G310100: Drill
• D768G310090: Drill
• D768G310080: Drill
• D768G212950: Implant Driver