EFUCERA AC

GUDID 04582594094772

YAMAHACHI DENTAL MFG.,CO.

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• Primary Device ID: 04582594094772
• NIH Device Record Key: 3179dea3-9b39-4497-9b7e-d16a57af5042
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EFUCERA AC
• Version Model Number: 36, 34, A3
• Company DUNS: 693430001
• Company Name: YAMAHACHI DENTAL MFG.,CO.
• 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	04582594094772 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K060507

FDA Product Code

• ELM: Denture, Plastic, Teeth

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-11-29
• Device Publish Date: 2021-11-20

On-Brand Devices [EFUCERA AC]

• 04582276122328: 32U, D2
• 04582276021195: 36L, W0.5
• 04582276021188: 36U, W0.5
• 04582276021164: 36L, D4
• 04582276021157: 36U, D4
• 04582276021133: 36L, D3
• 04582276021126: 36U, D3
• 04582276021102: 36L, D2
• 04582276021096: 36U, D2
• 04582276021072: 36L, C4
• 04582276021065: 36U, C4
• 04582276021041: 36L, C3
• 04582276021034: 36U, C3
• 04582276021010: 36L, C2
• 04582276021003: 36U, C2
• 04582276020983: 36L, C1
• 04582276020976: 36U, C1
• 04582276020952: 36L, B4
• 04582276020945: 36U, B4
• 04582276020921: 36L, B3
• 04582276020914: 36U, B3
• 04582276020891: 36L, B2
• 04582276020884: 36U, B2
• 04582276020860: 36L, B1
• 04582276020853: 36U, B1
• 04582276020839: 36L, A4
• 04582276020822: 36U, A4
• 04582276020808: 36L, A3.5
• 04582276020792: 36U, A3.5
• 04582276020778: 36L, A3
• 04582276020761: 36U, A3
• 04582276020747: 36L, A2
• 04582276020730: 36U, A2
• 04582276020716: 36L, A1
• 04582276020709: 36U, A1
• 04582276020686: 34L, W0.5
• 04582276020679: 34U, W0.5
• 04582276020662: 34L, D4
• 04582276020655: 34U, D4
• 04582276020631: 34L, D3
• 04582276020624: 34U, D3
• 04582276020600: 34L, D2
• 04582276020594: 34U, D2
• 04582276020570: 34L, C4
• 04582276020563: 34U, C4
• 04582276020549: 34L, C3
• 04582276020532: 34U, C3
• 04582276020518: 34L, C2
• 04582276020501: 34U, C2
• 04582276020488: 34L, C1