ET SmartFit Abutment

GUDID 00814913023502

HIOSSEN, INC.

Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece

• Primary Device ID: 00814913023502
• NIH Device Record Key: 54186369-63d9-42c4-a62d-dc14ca26c0f1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ET SmartFit Abutment
• Version Model Number: ETCMASH
• Company DUNS: 796083090
• Company Name: HIOSSEN, 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: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00814913023502 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K123627

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-09-08

On-Brand Devices [ET SmartFit Abutment]

• 00814913026145: P-ETCMASHC
• 00814913026138: P-ETCMASNC
• 00814913026121: P-ETCMAMHC
• 00814913026114: P-ETCMAMNC
• 00814913023519: ETCMASN
• 00814913023502: ETCMASH
• 00814913023496: ETCMAMN
• 00814913023489: ETCMAMH