Restore R9650-40-03K

GUDID D768R96504003K0

Healing Abutment

KEYSTONE DENTAL, INC.

Dental implant suprastructure, temporary, preformed, single-use

• Primary Device ID: D768R96504003K0
• NIH Device Record Key: 9ba9196f-7e01-4fcf-b0c2-1549b653fbf7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Restore
• Version Model Number: R9650-40-03K
• Catalog Number: R9650-40-03K
• 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	D768R96504003K0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K002037

FDA Product Code

• NHA: ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS

Sterilization

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

[D768R96504003K0]

Radiation Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-12-07
• Device Publish Date: 2016-02-04

On-Brand Devices [Restore]

• D768R939434K0: Waxing Pin
• D768R91925015K0: Placement Head
• D768R91924015K0: Placement Head
• D768R91924005K0: Placement Head
• D768R91923315K0: Placement Head
• D768R91923305K0: Placement Head
• D768R918533K0: Depth Gauge
• D768R91364210K0: Drill
• D768R91353015K0: Drill
• D768R9122K0: Hex Driver
• D768R9121K0: Hex Driver
• D768R9118K0: Depth Gauge
• D768L280801K0: Seating Tool
• D768L280201K0: Reamer
• D768L280003K0: Reamer
• D768L280002K0: Reamer
• D768L280001K0: Reamer
• D768L21019616K0: Abutment Driver
• D768L21009619K0: Abutment Driver
• D768L21008524K0: Square Driver
• D768L21008519K0: Square Driver
• D768L21008019K0: Conical Driver
• D768L21006224K0: Hex Driver
• D768L21006219K0: Hex Driver
• D768L21003524K0: Hex Driver
• D768L21003519K0: Hex Driver
• D768L181301K0: Placement Head Assy Kit
• D768L180605K0: Adapter
• D768L180604K0: Adapter
• D768L180603K0: Adapter
• D768L18052025K0: Parallel Pin
• D768L18052015K0: Parallel Pin
• D768L18052000K0: Parallel Pin
• D768L180501K0: Depth Gauge
• D768L180301K0: Depth Gauge
• D768L18002202K0: Port Cleaner
• D768L170901K0: Wrench
• D768L170301K0: Extender
• D768L170072K0: Thread Tap
• D768L170025K0: Thread Tap
• D768L170020K0: Thread Tap
• D768L15046015K0: Tap
• D768L15046013K0: Tap
• D768L15045015K0: Tap
• D768L15045013K0: Tap
• D768L15044018K0: Tap
• D768L15044013K0: Tap
• D768L15043818K0: Tap
• D768L15043813K0: Tap
• D768L15026015K0: Tap