NEW ACE/EFUCERA AC COMBINATION SET

GUDID 04582594094345

YAMAHACHI DENTAL MFG.,CO.

Resin artificial teeth

• Primary Device ID: 04582594094345
• NIH Device Record Key: 7bb8de75-93ad-4e03-a003-c72d4df9cc33
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NEW ACE/EFUCERA AC COMBINATION SET
• Version Model Number: TL4L634, W0.5
• 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	04582594094345 [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 [NEW ACE/EFUCERA AC COMBINATION SET]

• 04582594094390: O5L634, W0.5
• 04582594094383: S7L1034, W0.5
• 04582594094376: S6L734, W0.5
• 04582594094369: S2S3L28, W0.5
• 04582594094352: TL7L1134, W0.5
• 04582594094345: TL4L634, W0.5
• 04582594094338: T6L734, W0.5
• 04582594094321: T5L732, W0.5
• 04582594094314: T4L430, W0.5
• 04582594094307: T3L630, W0.5
• 04582594094291: T2L230, W0.5