EFUCERA PX

GUDID 04582594094932

YAMAHACHI DENTAL MFG.,CO.

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• Primary Device ID: 04582594094932
• NIH Device Record Key: 423ce3c1-ed3b-46b2-a42e-1d2172c93ed7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EFUCERA PX
• Version Model Number: 32, 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	04582594094932 [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 PX]

• 04582276027012: 36L, W0.5
• 04582276027005: 36U, W0.5
• 04582276026985: 36L, D4
• 04582276026978: 36U, D4
• 04582276026954: 36L, D3
• 04582276026947: 36U, D3
• 04582276026923: 36L, D2
• 04582276026916: 36U, D2
• 04582276026893: 36L, C4
• 04582276026886: 36U, C4
• 04582276026862: 36L, C3
• 04582276026855: 36U, C3
• 04582276026831: 36L, C2
• 04582276026824: 36U, C2
• 04582276026800: 36L, C1
• 04582276026794: 36U, C1
• 04582276026770: 36L, B4
• 04582276026763: 36U, B4
• 04582276026749: 36L, B3
• 04582276026732: 36U, B3
• 04582276026718: 36L, B2
• 04582276026701: 36U, B2
• 04582276026688: 36L, B1
• 04582276026671: 36U, B1
• 04582276026657: 36L, A4
• 04582276026640: 36U, A4
• 04582276026626: 36L, A3.5
• 04582276026619: 36U, A3.5
• 04582276026596: 36L, A3
• 04582276026589: 36U, A3
• 04582276026565: 36L, A2
• 04582276026558: 36U, A2
• 04582276026534: 36L, A1
• 04582276026527: 36U, A1
• 04582276026503: 34L, W0.5
• 04582276026497: 34U, W0.5
• 04582276026480: 34L, D4
• 04582276026473: 34U, D4
• 04582276026459: 34L, D3
• 04582276026442: 34U, D3
• 04582276026428: 34L, D2
• 04582276026411: 34U, D2
• 04582276026398: 34L, C4
• 04582276026381: 34U, C4
• 04582276026367: 34L, C3
• 04582276026350: 34U, C3
• 04582276026336: 34L, C2
• 04582276026329: 34U, C2
• 04582276026305: 34L, C1
• 04582276026299: 34U, C1