SD Bone Level Fixture

GUDID 08800265646003

ARUM DENTISTRY Co., Ltd.

Dental implant system

• Primary Device ID: 08800265646003
• NIH Device Record Key: b1d08dfd-4f97-4fca-b2f2-c95cf1fe91a7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SD Bone Level Fixture
• Version Model Number: B4510
• 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: 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	08800265646003 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K241703

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: 2026-03-18
• Device Publish Date: 2026-03-10

On-Brand Devices [SD Bone Level Fixture]

• 08809982751700: B3307P
• 08809982751694: B3310P
• 08809982751687: B3313P
• 08809982751670: B3608P
• 08809982751663: B3611P
• 08809982751656: B3308P
• 08809982751649: B3311P
• 08809982751632: B3607P
• 08809982751625: B3610P
• 08809982751618: B3613P
• 08800265646317: B3613
• 08800265646300: B3611
• 08800265646294: B3608
• 08800265646287: B3313
• 08800265646263: B4007
• 08800265646256: B4011
• 08800265646249: B4508
• 08800265646225: B3610
• 08800265646218: B3607
• 08800265646201: B3310
• 08800265646164: B4511
• 08800265646157: B3308
• 08800265646096: B4010
• 08800265646089: B4507
• 08800265646072: B3307
• 08800265646027: B4008
• 08800265646010: B4013
• 08800265646003: B4510
• 08800265645860: B3311
• 08800265644115: B6011P
• 08800265644108: B6010P
• 08800265644092: B6008P
• 08800265644085: B6007P
• 08800265644061: B5013P
• 08800265644054: B5011P
• 08800265644047: B5010P
• 08800265644030: B5008P
• 08800265644023: B5007P
• 08800265644009: B4513P
• 08800265643996: B4511P
• 08800265643989: B4510P
• 08800265643972: B4508P
• 08800265643965: B4507P
• 08800265643941: B4013P
• 08800265643934: B4011P
• 08800265643927: B4010P
• 08800265643910: B4008P
• 08800265643903: B4007P
• 08800265640476: B4513
• 08800265640452: B5007