Genesis

GUDID D768G310000

Surgical Tray

KEYSTONE DENTAL, INC.

Dental/maxillofacial surgical procedure kit, non-medicated, reusable

• Primary Device ID: D768G310000
• NIH Device Record Key: f06251bf-63d2-486b-ac17-2ea087751fb3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Genesis
• Version Model Number: G31000
• Company DUNS: 787471015
• Company Name: KEYSTONE DENTAL, INC.
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(781)328-3313
• Email: sshahid@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 Identifiers

Device Issuing Agency	Device ID
HIBCC	D768G310000 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K101545

FDA Product Code

• OFY: Dental implant surgical tray

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-06-03
• Device Publish Date: 2019-05-24

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