Cemented Abutment

GUDID 08800055796314

ARUM DENTISTRY Co., Ltd.

Dental implant suprastructure, permanent, preformed

• Primary Device ID: 08800055796314
• NIH Device Record Key: c17b7b7f-86ea-40ac-84ac-b6b675f5ff9d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cemented Abutment
• Version Model Number: SACN6545RP
• Company DUNS: 557821945
• Company Name: ARUM DENTISTRY Co., Ltd.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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	08800055796314 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K222131

FDA Product Code

• DZE: Implant, Endosseous, Root-Form

Sterilization

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

[08800055796314]

Moist Heat or Steam Sterilization

[08800055796314]

Moist Heat or Steam Sterilization

[08800055796314]

Moist Heat or Steam Sterilization

[08800055796314]

Moist Heat or Steam Sterilization

[08800055796314]

Moist Heat or Steam Sterilization

[08800055796314]

Moist Heat or Steam Sterilization

[08800055796314]

Moist Heat or Steam Sterilization

[08800055796314]

Moist Heat or Steam Sterilization

[08800055796314]

Moist Heat or Steam Sterilization

[08800055796314]

Moist Heat or Steam Sterilization

[08800055796314]

Moist Heat or Steam Sterilization

[08800055796314]

Moist Heat or Steam Sterilization

[08800055796314]

Moist Heat or Steam Sterilization

[08800055796314]

Moist Heat or Steam Sterilization

[08800055796314]

Moist Heat or Steam Sterilization

[08800055796314]

Moist Heat or Steam Sterilization

[08800055796314]

Moist Heat or Steam Sterilization

[08800055796314]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-04-07
• Device Publish Date: 2023-03-30

On-Brand Devices [Cemented Abutment]

• 08800055796390: SACN6567RP
• 08800055796383: SACN6557RP
• 08800055796376: SACN6547RP
• 08800055796369: SACN6537RP
• 08800055796352: SACN6527RP
• 08800055796345: SACN6517RP
• 08800055796338: SACN6565RP
• 08800055796321: SACN6555RP
• 08800055796314: SACN6545RP
• 08800055796307: SACN6535RP
• 08800055796291: SACN6525RP
• 08800055796284: SACN6515RP
• 08800055796277: SACN5567RP
• 08800055796253: SACN5547RP
• 08800055796246: SACN5537RP
• 08800055796239: SACN5527RP
• 08800055796222: SACN5517RP
• 08800055796215: SACN5565RP
• 08800055796208: SACN5555RP
• 08800055796192: SACN5545RP
• 08800055796185: SACN5535RP
• 08800055796178: SACN5525RP
• 08800055796161: SACN5515RP
• 08800055796154: SACN4567RP
• 08800055796147: SACN4557RP
• 08800055796130: SACN4547RP
• 08800055796123: SACN4537RP
• 08800055796116: SACN4527RP
• 08800055796109: SACN4517RP
• 08800055796093: SACN4565RP
• 08800055796086: SACN4555RP
• 08800055796079: SACN4545RP
• 08800055796062: SACN4535RP
• 08800055796055: SACN4525RP
• 08800055796048: SACN4515RP
• 08800055796031: SACH6567RP
• 08800055796024: SACH6557RP
• 08800055796017: SACH6547RP
• 08800055796000: SACH6537RP
• 08800055795997: SACH6527RP
• 08800055795980: SACH6517RP
• 08800055795973: SACH6565RP
• 08800055795966: SACH6555RP
• 08800055795959: SACH6545RP
• 08800055795942: SACH6535RP
• 08800055795935: SACH6525RP
• 08800055795928: SACH6515RP
• 08800055795911: SACH5567RP
• 08800055795904: SACH5557RP
• 08800055795898: SACH5547RP