O-Ring Abutment O-Ring

GUDID 08806169134363

O-Ring Abutment O-Ring (DOAO400)

DENTIS CO. ,LTD

Dental implant suprastructure, permanent, preformed

• Primary Device ID: 08806169134363
• NIH Device Record Key: e48b705b-0aca-4fdf-ad2c-419c1ae1856b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: O-Ring Abutment O-Ring
• Version Model Number: DOAO400
• Company DUNS: 694721181
• Company Name: DENTIS CO. ,LTD
• 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: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08806169134363 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K230126

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: 2023-08-18
• Device Publish Date: 2023-08-10

On-Brand Devices [O-Ring Abutment O-Ring ]

• 08806169134387: O-Ring Abutment O-Ring (DOAO800)
• 08806169134363: O-Ring Abutment O-Ring (DOAO400)