NEW ACE/NAPERCE COMBINATION SET

GUDID 04582594094284

YAMAHACHI DENTAL MFG.,CO.

Resin artificial teeth

• Primary Device ID: 04582594094284
• NIH Device Record Key: 2b36ee56-6aee-4c2a-b2cf-ff02165973a0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NEW ACE/NAPERCE COMBINATION SET
• Version Model Number: T2L2M34, 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	04582594094284 [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

Devices Manufactured by YAMAHACHI DENTAL MFG.,CO.

• D080XXPMD95MM1535M0 - PMMA DISK: 2024-09-20
• D080XXPMD95MM15A1M0 - PMMA DISK: 2024-09-20
• D080XXPMD95MM15A2M0 - PMMA DISK: 2024-09-20
• D080XXPMD95MM15A3M0 - PMMA DISK: 2024-09-20
• D080XXPMD95MM15A4M0 - PMMA DISK: 2024-09-20
• D080XXPMD95MM15B1M0 - PMMA DISK: 2024-09-20
• D080XXPMD95MM15B2M0 - PMMA DISK: 2024-09-20
• D080XXPMD95MM15B3M0 - PMMA DISK: 2024-09-20