SHADE GUIDE AC

GUDID D080SDGAC17PCSX17C0

YAMAHACHI DENTAL MFG.,CO.

Dental shade guide

• Primary Device ID: D080SDGAC17PCSX17C0
• NIH Device Record Key: 55d09e07-ade7-481b-bc29-3d366d9aeae7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SHADE GUIDE AC
• Version Model Number: SHADE GUIDE AC,17PCS,17C
• 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: true
• 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
HIBCC	D080SDGAC17PCSX17C0 [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: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2026-02-09
• Device Publish Date: 2025-11-19

Devices Manufactured by YAMAHACHI DENTAL MFG.,CO.

• D080SDGAC17PCSX17C0 - SHADE GUIDE AC: 2026-02-09
• D080SDGAC17PCSX17C0 - SHADE GUIDE AC: 2026-02-09
• D080SDGPX17PCSX17C0 - SHADE GUIDE CROWN PX: 2026-02-09
• 04582276126500 - CROWN PX: 2026-01-29 4sets/box
• 04582276127125 - CROWN PX: 2026-01-29 4sets/box
• 04582276127149 - CROWN PX: 2026-01-29 4sets/box
• 04582276127422 - CROWN PX: 2026-01-29 4sets/box
• 04582276127460 - CROWN PX: 2026-01-29 4sets/box
• 04582276126401 - CROWN PX: 2026-01-28 4sets/box