ET FREEFORM ST ABUTMENT SET

GUDID 00810125994241

HIOSSEN, INC.

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

• Primary Device ID: 00810125994241
• NIH Device Record Key: 864c80fb-c6f8-4084-ba0f-0743b07e30b0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ET FREEFORM ST ABUTMENT SET
• Version Model Number: ETFA5030NCWH
• 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: false
• 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	00810125994241 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K222636

FDA Product Code

• NHA: Abutment, 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: 2024-07-15
• Device Publish Date: 2024-07-06

On-Brand Devices [ET FREEFORM ST ABUTMENT SET]

• 00810125994364: ETFAS5030NCWH
• 00810125994357: ETFAS5030CWH
• 00810125994340: ETFAS5015NCWH
• 00810125994333: ETFAS5015CWH
• 00810125994326: ETFA7030NCWH
• 00810125994319: ETFA7030CWH
• 00810125994302: ETFA7015NCWH
• 00810125994296: ETFA7015CWH
• 00810125994289: ETFA6030NCWH
• 00810125994272: ETFA6030CWH
• 00810125994265: ETFA6015NCWH
• 00810125994258: ETFA6015CWH
• 00810125994241: ETFA5030NCWH
• 00810125994234: ETFA5030CWH
• 00810125994227: ETFA5015NCWH
• 00810125994210: ETFA5015CWH
• 00810125994203: ETFA4030NCWH
• 00810125994197: ETFA4030CWH
• 00810125994180: ETFA4015NCWH
• 00810125994173: ETFA4015CWH
• 00810125994166: ETFAM4030NCWH
• 00810125994159: ETFAM4030CWH
• 00810125994142: ETFAM4015NCWH
• 00810125994135: ETFAM4015CWH