FLAT AC

GUDID D080SSFLAXX32XLXC40

YAMAHACHI DENTAL MFG.,CO.

Resin artificial teeth

• Primary Device ID: D080SSFLAXX32XLXC40
• NIH Device Record Key: 8e6ea805-bf11-43c1-ac5a-2c872495b824
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FLAT AC
• Version Model Number: 8*1SET,32,L,C4
• 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	D080SSFLAXX32XLXC40 [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