SOLUUT PX

GUDID D080SSSOAXLS7XLXB10

YAMAHACHI DENTAL MFG.,CO.

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• Primary Device ID: D080SSSOAXLS7XLXB10
• NIH Device Record Key: d1652887-4292-49fe-a97e-24a48d239dbf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SOLUUT PX
• Version Model Number: 6*1SET,LS7,L,B1
• 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
HIBCC	D080SSSOAXLS7XLXB10 [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: 2023-10-09
• Device Publish Date: 2023-09-29

On-Brand Devices [SOLUUT PX]

• D080SSSOAXXT7XUXA10: 6*1SET,T7,U,A1
• D080SSSOAXXT6XUXA10: 6*1SET,T6,U,A1
• D080SSSOAXXT5XUXA10: 6*1SET,T5,U,A1
• D080SSSOAXXT4XUXA10: 6*1SET,T4,U,A1
• D080SSSOAXXS7XUXA10: 6*1SET,S7,U,A1
• D080SSSOAXXS6XUXA10: 6*1SET,S6,U,A1
• D080SSSOAXXS5XUXA10: 6*1SET,S5,U,A1
• D080SSSOAXXS4XUXA10: 6*1SET,S4,U,A1
• D080SSSOAXSS5XUXA10: 6*1SET,SS5,U,A1
• D080SSSOAXSS4XUXA10: 6*1SET,SS4,U,A1
• D080SSSOAXXL4XLXA40: 6*1SET,L4,L,A4
• D080SSSOAXXC7XUW050: 6*1SET,C7,U,W0.5
• D080SSSOAXXC6XUXA10: 6*1SET,C6,U,A1
• D080SSSOAXXC5XUXA30: 6*1SET,C5,U,A3
• D080SSSOAXXC5XUXA10: 6*1SET,C5,U,A1
• D080SSSOAXSS7XUXA10: 6*1SET,SS7,U,A1
• D080SSSOAXSS6XUXA10: 6*1SET,SS6,U,A1
• D080SSSOAXXL7XLXB10: 6*1SET,L7,L,B1
• D080SSSOAXLS5XLXA10: 6*1SET,LS5,L,A1
• D080SSSOAXLS5XLW050: 6*1SET,LS5,L,W0.5
• D080SSSOAXLS4XLXB10: 6*1SET,LS4,L,B1
• D080SSSOAXXT7XUXD40: 6*1SET,T7,U,D4
• D080SSSOAXXT7XUXD30: 6*1SET,T7,U,D3
• D080SSSOAXXT7XUXD20: 6*1SET,T7,U,D2
• D080SSSOAXXT7XUXC40: 6*1SET,T7,U,C4
• D080SSSOAXXT7XUXC30: 6*1SET,T7,U,C3
• D080SSSOAXXT7XUXC20: 6*1SET,T7,U,C2
• D080SSSOAXXT7XUXC10: 6*1SET,T7,U,C1
• D080SSSOAXXT7XUXB40: 6*1SET,T7,U,B4
• D080SSSOAXXT7XUXB30: 6*1SET,T7,U,B3
• D080SSSOAXXT7XUXB20: 6*1SET,T7,U,B2
• D080SSSOAXXT7XUXB10: 6*1SET,T7,U,B1
• D080SSSOAXXT7XUXA40: 6*1SET,T7,U,A4
• D080SSSOAXXT7XUXA30: 6*1SET,T7,U,A3
• D080SSSOAXXT7XUXA20: 6*1SET,T7,U,A2
• D080SSSOAXXT7XUW050: 6*1SET,T7,U,W0.5
• D080SSSOAXXT7XUA350: 6*1SET,T7,U,A3.5
• D080SSSOAXXT6XUXD40: 6*1SET,T6,U,D4
• D080SSSOAXXT6XUXD30: 6*1SET,T6,U,D3
• D080SSSOAXXT6XUXD20: 6*1SET,T6,U,D2
• D080SSSOAXXT6XUXC40: 6*1SET,T6,U,C4
• D080SSSOAXXT6XUXC30: 6*1SET,T6,U,C3
• D080SSSOAXXT6XUXC20: 6*1SET,T6,U,C2
• D080SSSOAXXT6XUXC10: 6*1SET,T6,U,C1
• D080SSSOAXXT6XUXB40: 6*1SET,T6,U,B4
• D080SSSOAXXT6XUXB30: 6*1SET,T6,U,B3
• D080SSSOAXXT6XUXB20: 6*1SET,T6,U,B2
• D080SSSOAXXT6XUXB10: 6*1SET,T6,U,B1
• D080SSSOAXXT6XUXA40: 6*1SET,T6,U,A4
• D080SSSOAXXT6XUXA30: 6*1SET,T6,U,A3