ExHex EPC Abutment

GUDID D768EPCTN503KT0

EPC Abutment

KEYSTONE DENTAL, INC.

Dental implant suprastructure, permanent, preformed

• Primary Device ID: D768EPCTN503KT0
• NIH Device Record Key: ba0e3d50-97ab-44ff-aac8-430cf1b4230b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ExHex
• Version Model Number: EPC-TN-50-3KT
• Catalog Number: EPC Abutment
• 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: 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: 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D768EPCTN503KT0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K070905

FDA Product Code

• NHA: ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-11-08
• Device Publish Date: 2017-07-06

On-Brand Devices [ExHex]

• D768TSUZ90: Retention Screw
• D768TSU90: Retention Screw
• D768TSU30: Retention Screw
• D768TSU20: Retention Screw
• D768TSU10: Retention Screw
• D768TSHZ30: Retention Screw
• D768TSHZ20: Retention Screw
• D768TSH30: Retention Screw
• D768TSH20: Retention Screw
• D768TSH10: Retention Screw
• D768SMAX9NH0: Passive Abutment
• D768SMAX9H0: Passive Abutment
• D768SBBB17TT0: Passive Abutment
• D768SBBB160: Passive Abutment
• D768SBA17TT0: Passive Abutment
• D768SBA160: Passive Abutment
• D768SB17TT0: Passive Abutment
• D768SB160: Passive Abutment
• D768GSUZ30: Retention Screw
• D768GSU90: Retention Screw
• D768GSU30: Retention Screw
• D768GSU20: Retention Screw
• D768GSU10: Retention Screw
• D768GSS90: Retention Screw
• D768GSQZ30: Retention Screw
• D768GSQZ20: Retention Screw
• D768GSQ30: Retention Screw
• D768GSQ20: Retention Screw
• D768GSIT20: Retention Screw
• D768GSH10: Retention Screw
• D768GMCW10: Gold Sleeve
• D768GMC10: Gold Sleeve
• D768GCNX700: Gold Sleeve
• D768GCNX600: Gold Sleeve
• D768GCNX500: Gold Sleeve
• D768GCNX400: Gold Sleeve
• D768GCNX340: Gold Sleeve
• D768GCEX700: Gold Sleeve
• D768GCEX600: Gold Sleeve
• D768GCEX500: Gold Sleeve
• D768GCEX400: Gold Sleeve
• D768GCEX340: Gold Sleeve
• D768EPCTN603KT0: EPC Abutment
• D768EPCTN602KT0: EPC Abutment
• D768EPCTN601KT0: EPC Abutment
• D768EPCTN503KT0: EPC Abutment
• D768EPCTN502KT0: EPC Abutment
• D768EPCTN501KT0: EPC Abutment
• D768EPCTN433KT0: EPC Abutment
• D768EPCTN432KT0: EPC Abutment