ARUM NB 1 SA Fixture

GUDID 08800055700731

ARUM DENTISTRY Co., Ltd.

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: 08800055700731
• NIH Device Record Key: d5ed2a84-49e0-4d67-8142-13ed42b90cdd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ARUM NB 1 SA Fixture
• Version Model Number: NB15011SP
• Company DUNS: 557821945
• Company Name: ARUM DENTISTRY 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: true
• 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	08800055700731 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K213506

FDA Product Code

• DZE: Implant, Endosseous, Root-Form

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-06-16
• Device Publish Date: 2022-06-08

On-Brand Devices [ARUM NB 1 SA Fixture]

• 08800055755748: NB15513SS
• 08800055755731: NB15511SS
• 08800055755724: NB15510SS
• 08800055755717: NB15508SS
• 08800055755700: NB15507SS
• 08800055755694: NB15506SS
• 08800055755687: NB15013SS
• 08800055755670: NB15011SS
• 08800055755663: NB15010SS
• 08800055755656: NB15008SS
• 08800055755649: NB15007SS
• 08800055755632: NB14513SS
• 08800055755625: NB14511SS
• 08800055755618: NB14510SS
• 08800055755601: NB14508SS
• 08800055755595: NB14507SS
• 08800055755588: NB14013SS
• 08800055755571: NB14011SS
• 08800055755564: NB14010SS
• 08800055755557: NB14008SS
• 08800055755540: NB14007SS
• 08800055755533: NB13813SS
• 08800055755526: NB13811SS
• 08800055755519: NB13810SS
• 08800055755502: NB13808SS
• 08800055700557: NB16511S
• 08800055700540: NB16510S
• 08800055700533: NB16508S
• 08800055700526: NB16507S
• 08800055700519: NB16506S
• 08800055700502: NB16013S
• 08800055700496: NB16011S
• 08800055700489: NB16010S
• 08800055700472: NB16008S
• 08800055700465: NB16007S
• 08800055700458: NB16006S
• 08800055700441: NB15513S
• 08800055700434: NB15511S
• 08800055700427: NB15510S
• 08800055700410: NB15508S
• 08800055700403: NB15507S
• 08800055700397: NB15506S
• 08800055700380: NB15013S
• 08800055700373: NB15011S
• 08800055700366: NB15010S
• 08800055700359: NB15008S
• 08800055700342: NB15007S
• 08800055700335: NB14513S
• 08800055700328: NB14511S
• 08800055700311: NB14510S