XP1

GUDID D768T306030

Ratchet

KEYSTONE DENTAL, INC.

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• Primary Device ID: D768T306030
• NIH Device Record Key: cbdd4a74-74c0-4501-a0f0-abc967784ed1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: XP1
• Version Model Number: T30603
• 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
• 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	D768T306030 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K071070

FDA Product Code

• NDP: Accessories, implant, dental, endosseous

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: 2019-05-16
• Device Publish Date: 2019-05-08

Devices Manufactured by KEYSTONE DENTAL, INC.

• D768G151000 - Genesis ACTIVE: 2023-06-27 Genesis DLC Full Depth Twist Drill Ø2.0 x 8.5-16 mm
• D768G151010 - Genesis ACTIVE: 2023-06-27 Genesis DLC Final Tapered Drill Ø3.5 x 8.5 mm
• D768G151020 - Genesis ACTIVE: 2023-06-27 Genesis DLC Final Tapered Drill Ø3.5 x 10 mm
• D768G151030 - Genesis ACTIVE: 2023-06-27 Genesis DLC Final Tapered Drill Ø3.5 x 11.5 mm
• D768G151040 - Genesis ACTIVE: 2023-06-27 Genesis DLC Final Tapered Drill Ø3.5 x 13 mm
• D768G151050 - Genesis ACTIVE: 2023-06-27 Genesis DLC Final Tapered Drill Ø3.5 x 16 mm
• D768G151060 - Genesis ACTIVE: 2023-06-27 Genesis DLC Final Tapered Drill Ø3.8 x 8.5 mm
• D768G151070 - Genesis ACTIVE: 2023-06-27 Genesis DLC Final Tapered Drill Ø3.8 x 10 mm