Yomi S YomiLink Teeth Posterior LLUR

GUDID 00810004900684

Yomi S YomiLink Teeth Posterior LLUR

NEOCIS INC

Dental stereotactic surgery system

• Primary Device ID: 00810004900684
• NIH Device Record Key: 5cd5ab26-da70-42d5-ae33-8fd074f2c933
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Yomi S YomiLink Teeth Posterior LLUR
• Version Model Number: DRW-2773-01
• Company DUNS: 802312434
• Company Name: NEOCIS INC
• 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: false
• 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	00810004900684 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K252376

FDA Product Code

• PLV: Dental Stereotaxic Instrument

Sterilization

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

[00810004900684]

Moist Heat or Steam Sterilization

[00810004900684]

Moist Heat or Steam Sterilization

[00810004900684]

Moist Heat or Steam Sterilization

[00810004900684]

Moist Heat or Steam Sterilization

[00810004900684]

Moist Heat or Steam Sterilization

[00810004900684]

Moist Heat or Steam Sterilization

[00810004900684]

Moist Heat or Steam Sterilization

[00810004900684]

Moist Heat or Steam Sterilization

[00810004900684]

Moist Heat or Steam Sterilization

[00810004900684]

Moist Heat or Steam Sterilization

[00810004900684]

Moist Heat or Steam Sterilization

[00810004900684]

Moist Heat or Steam Sterilization

[00810004900684]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-12-09
• Device Publish Date: 2025-12-01

Devices Manufactured by NEOCIS INC

• 00810004900639 - Yomi S Extra Oral Fiducial Array LLUR: 2025-12-09 Yomi S Extra Oral Fiducial Array LLUR
• 00810004900646 - Yomi S Extra Oral Fiducial Array LRUL: 2025-12-09 Yomi S Extra Oral Fiducial Array LRUL
• 00810004900653 - Yomi S Intra Oral Fiducial Array Small: 2025-12-09 Yomi S Intra Oral Fiducial Array Small
• 00810004900660 - Yomi S Intra Oral Fiducial Array Medium: 2025-12-09 Yomi S Intra Oral Fiducial Array Medium
• 00810004900677 - Yomi S Intra Oral Fiducial Array Large: 2025-12-09 Yomi S Intra Oral Fiducial Array Large
• 00810004900684 - Yomi S YomiLink Teeth Posterior LLUR: 2025-12-09Yomi S YomiLink Teeth Posterior LLUR
• 00810004900684 - Yomi S YomiLink Teeth Posterior LLUR: 2025-12-09 Yomi S YomiLink Teeth Posterior LLUR
• 00810004900691 - Yomi S YomiLink Teeth Posterior LRUL: 2025-12-09 Yomi S YomiLink Teeth Posterior LRUL
• 00810004900707 - Yomi S YomiLink Arch LLUR: 2025-12-09 Yomi S YomiLink Arch LLUR