O-Ring Abutment Retainer

GUDID 08800053000055

O-Ring Abutment Retainer (DORS = DOR(K073486) + DOAO100(D079308) + DOAO400(K230126) + DOAO800(K230126))

DENTIS CO. ,LTD

Dental implant suprastructure, temporary, preformed, single-use

• Primary Device ID: 08800053000055
• NIH Device Record Key: 47c9593f-bf41-4f0f-88ce-7b47d26dd520
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: O-Ring Abutment Retainer
• Version Model Number: DORS
• 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	08800053000055 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K230126

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

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

[08800053000055]

Moist Heat or Steam Sterilization

[08800053000055]

Moist Heat or Steam Sterilization

[08800053000055]

Moist Heat or Steam Sterilization

[08800053000055]

Moist Heat or Steam Sterilization

[08800053000055]

Moist Heat or Steam Sterilization

[08800053000055]

Moist Heat or Steam Sterilization

[08800053000055]

Moist Heat or Steam Sterilization

[08800053000055]

Moist Heat or Steam Sterilization

[08800053000055]

Moist Heat or Steam Sterilization

[08800053000055]

Moist Heat or Steam Sterilization

[08800053000055]

Moist Heat or Steam Sterilization

[08800053000055]

Moist Heat or Steam Sterilization

[08800053000055]

Moist Heat or Steam Sterilization

[08800053000055]

Moist Heat or Steam Sterilization

[08800053000055]

Moist Heat or Steam Sterilization

[08800053000055]

Moist Heat or Steam Sterilization

[08800053000055]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-11-13
• Device Publish Date: 2023-11-03

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