ET Convertible Abutment

GUDID 00810125996207

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 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: 00810125996207
• NIH Device Record Key: 4ac90a97-5df2-483e-8be3-e8aa58780e3b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ET Convertible Abutment
• Version Model Number: ETCA6030CP
• 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	00810125996207 [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: 2024-07-01
• Device Publish Date: 2024-06-21

On-Brand Devices [ET Convertible Abutment ]

• 00810125996221: ETCA6050CP
• 00810125996214: ETCA6040CP
• 00810125996207: ETCA6030CP
• 00810125996191: ETCA6020CP
• 00810125996184: ETCA6010CP
• 00810125996177: ETCA5050CP
• 00810125996160: ETCA5040CP
• 00810125996153: ETCA5030CP
• 00810125996146: ETCA5020CP
• 00810125996139: ETCA5010CP
• 00810125996122: ETCAS4040CP
• 00810125996115: ETCAS4030CP
• 00810125996108: ETCAS4020CP
• 00810125996092: ETCAS4010CP
• 00810125996085: ETCA4040CP
• 00810125996078: ETCA4030CP
• 00810125996061: ETCA4020CP
• 00810125996054: ETCA4010CP