Genesis G71212

GUDID D768G712120

Esth Con Abutment

KEYSTONE DENTAL, INC.

Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed

• Primary Device ID: D768G712120
• NIH Device Record Key: 3c707690-3a2d-4036-9013-6bb9b6c5fe42
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Genesis
• Version Model Number: G71212
• Catalog Number: G71212
• 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	D768G712120 [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

[D768G712120]

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: 2016-02-11

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