FLAT AC

GUDID D080SSFLAXX30XUXB30

YAMAHACHI DENTAL MFG.,CO.

Resin artificial teeth Resin artificial teeth Resin artificial teeth Resin artificial teeth Resin artificial teeth Resin artificial teeth Resin artificial teeth Resin artificial teeth Resin artificial teeth Resin artificial teeth Resin artificial teeth Resin artificial teeth Resin artificial teeth Resin artificial teeth Resin artificial teeth Resin artificial teeth Resin artificial teeth Resin artificial teeth

• Primary Device ID: D080SSFLAXX30XUXB30
• NIH Device Record Key: 98307ed3-fe91-48d7-91f4-9c78ac7a9ef4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FLAT AC
• Version Model Number: 8*1SET,30,U,B3
• 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	D080SSFLAXX30XUXB30 [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: 2023-09-11
• Device Publish Date: 2023-09-01

On-Brand Devices [FLAT AC]

• 04582276027722: 34L, B2
• 04582276027715: 34U, B2
• 04582276027708: 34L, B1
• 04582276027692: 34U, B1
• 04582276027685: 34L, A3.5
• 04582276027678: 34U, A3.5
• 04582276027654: 34L, A3
• 04582276027647: 34U, A3
• 04582276027623: 34L, A2
• 04582276027616: 34U, A2
• 04582276027593: 34L, A1
• 04582276027586: 34U, A1
• 04582276027555: 32L, B2
• 04582276027548: 32U, B2
• 04582276027531: 32L, B1
• 04582276027524: 32U, B1
• 04582276027517: 32L, A3.5
• 04582276027500: 32U, A3.5
• 04582276027487: 32L, A3
• 04582276027470: 32U, A3
• 04582276027456: 32L, A2
• 04582276027449: 32U, A2
• 04582276027425: 32L, A1
• 04582276027418: 32U, A1
• 04582276027333: 30L, B2
• 04582276027326: 30U, B2
• 04582276027319: 30L, B1
• 04582276027302: 30U, B1
• 04582276027296: 30L, A3.5
• 04582276027289: 30U, A3.5
• 04582276027265: 30L, A3
• 04582276027258: 30U, A3
• 04582276027234: 30L, A2
• 04582276027227: 30U, A2
• 04582276027203: 30L, A1
• 04582276027197: 30U, A1
• D080SSFLAXX34XUXB20: 34,U,B2
• D080SSFLAXX34XUXB10: 34,U,B1
• D080SSFLAXX34XUXA30: 34,U,A3
• D080SSFLAXX34XUA350: 34U, A3.5
• D080SSFLAXX34XLXB20: 34,L,B2
• D080SSFLAXX34XLXB10: 34,L,B1
• D080SSFLAXX34XLXA30: 34,L,A3
• D080SSFLAXX34XLA350: 34,L,A3.5
• D080SSFLAXX34XLXA20: 8*1SET,34,L,A2
• D080SSFLAXX34XLXA10: 8*1SET,34,L,A1
• D080SSFLAXX32XUXB20: 8*1SET,32,U,B2
• D080SSFLAXX32XUXB10: 8*1SET,32,U,B1
• D080SSFLAXX32XUXA30: 8*1SET,32,U,A3
• D080SSFLAXX32XUXA20: 8*1SET,32,U,A2