SIMPLERR PX

GUDID 04582276061252

YAMAHACHI DENTAL MFG.,CO.

Resin artificial teeth

• Primary Device ID: 04582276061252
• NIH Device Record Key: 424c05c2-7f98-4433-aa5f-26bd8f8bc526
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SIMPLERR PX
• Version Model Number: M28L, 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	04582276061252 [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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-02-20

On-Brand Devices [SIMPLERR PX]

• 04582276062587: M32L, D2
• 04582276062341: M32L, B1
• 04582276061757: M30L, A3
• 04582276061696: M30L, A1
• 04582276061252: M28L, A3
• 04582276061245: M28U, A3