ANAXDENT PMMA 18121116

GUDID 08435288495248

ANAXDENT PMMA DISC U MULTIBLANK COLOR A1 98,5/16mm

UNION DENTAL SA

Dental crown/bridge, temporary

• Primary Device ID: 08435288495248
• NIH Device Record Key: afcf206d-f868-40fb-9112-b3d89d4d0055
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ANAXDENT PMMA
• Version Model Number: U MULTIBLANK A1 98,5/16mm
• Catalog Number: 18121116
• Company DUNS: 462114760
• Company Name: UNION DENTAL SA
• 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: false
• 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	08435288495248 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150432

FDA Product Code

• EBG: Crown And Bridge, Temporary, Resin

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: 2020-10-14
• Device Publish Date: 2020-10-06

On-Brand Devices [ANAXDENT PMMA]

• 08435288499703: ANAXDENT PMMA DISC U X-RAY BLANK RADIOPAQUE 98,5/20mm
• 08435288497044: ANAXDENT PMMA DISC U 10-LAYER BLANK COLOR BL1 98,5/20mm
• 08435288496221: ANAXDENT PMMA DISC U MULTI BLANK COLOR A3 98,5/25mm
• 08435288496214: ANAXDENT PMMA DISC U MULTI BLANK COLOR A2 98,5/25mm
• 08435288496207: ANAXDENT PMMA DISC U MULTI BLANK COLOR A1 98,5/25mm
• 08435288496061: ANAXDENT PMMA DISC Z 10-LAYER BLANK COLOR B2 95/20mm
• 08435288496054: ANAXDENT PMMA DISC Z 10-LAYER BLANK COLOR B1 95/20mm
• 08435288496030: ANAXDENT PMMA DISC Z 10-LAYER BLANK COLOR A3,5 95/20mm
• 08435288496023: ANAXDENT PMMA DISC Z 10-LAYER BLANK COLOR A3 95/20mm
• 08435288496016: ANAXDENT PMMA DISC Z 10-LAYER BLANK COLOR A2 95/20mm
• 08435288496009: ANAXDENT PMMA DISC Z 10-LAYER BLANK COLOR A1 95/20mm
• 08435288495996: ANAXDENT PMMA DISC Z 10-LAYER BLANK COLOR B0 95/20mm
• 08435288495804: ANAXDENT PMMA DISC AG MULTI BLANK COLOR B2 101/20mm
• 08435288495798: ANAXDENT PMMA DISC AG MULTI BLANK COLOR B1 101/20mm
• 08435288495675: ANAXDENT PMMA DISC Z MULTI BLANK COLOR B2 95/16mm
• 08435288495668: ANAXDENT PMMA DISC Z MULTI BLANK COLOR B1 95/16mm
• 08435288495651: ANAXDENT PMMA DISC Z MULTI BLANK COLOR B0 95/16mm
• 08435288495637: ANAXDENT PMMA DISC Z MULTI BLANK COLOR A3,5 95/16mm
• 08435288495620: ANAXDENT PMMA DISC Z MULTI BLANK COLOR A3 95/16mm
• 08435288495613: ANAXDENT PMMA DISC Z MULTI BLANK COLOR A2 95/16mm
• 08435288495606: ANAXDENT PMMA DISC Z MULTI BLANK COLOR A1 95/16mm
• 08435288495521: ANAXDENT PMMA DISC U MULTIBLANK COLOR B2 98,5/16mm
• 08435288495514: ANAXDENT PMMA DISC U MULTIBLANK COLOR B1 98,5/16mm
• 08435288495491: ANAXDENT PMMA DISC U MULTIBLANK COLOR A3,5 98,5/16mm
• 08435288495415: ANAXDENT PMMA DISC Z MULTI BLANK COLOR B2 95/20mm
• 08435288495408: ANAXDENT PMMA DISC Z MULTI BLANK COLOR B1 95/20mm
• 08435288495385: ANAXDENT PMMA DISC Z MULTI BLANK COLOR A3,5 95/20mm
• 08435288495316: ANAXDENT PMMA DISC U MULTIBLANK COLOR B0 98,5/16mm
• 08435288495262: ANAXDENT PMMA DISC U MULTIBLANK COLOR A3 98,5/16mm
• 08435288495255: ANAXDENT PMMA DISC U MULTIBLANK COLOR A2 98,5/16mm
• 08435288495248: ANAXDENT PMMA DISC U MULTIBLANK COLOR A1 98,5/16mm
• 08435288495231: ANAXDENT PMMA DISC Z MULTI BLANK COLOR B0 95/20mm
• 08435288495224: ANAXDENT PMMA DISC U MULTIBLANK COLOR B2 98,5/20mm
• 08435288495217: ANAXDENT PMMA DISC U MULTIBLANK COLOR B1 98,5/20mm
• 08435288495187: ANAXDENT PMMA DISC Z MULTI BLANK COLOR A3 95/20mm
• 08435288495170: ANAXDENT PMMA DISC Z MULTI BLANK COLOR A2 95/20mm
• 08435288495163: ANAXDENT PMMA DISC Z MULTI BLANK COLOR A1 95/20mm
• 08435288495156: ANAXDENT PMMA DISC AG MULTI BLANK COLOR B0 101/20mm
• 08435288495132: ANAXDENT PMMA DISC U MULTIBLANK COLOR A3,5 98,5/20mm
• 08435288495101: ANAXDENT PMMA DISC AG MULTI BLANK COLOR A3 101/20mm
• 08435288495095: ANAXDENT PMMA DISC AG MULTI BLANK COLOR A2 101/20mm
• 08435288495088: ANAXDENT PMMA DISC AG MULTI BLANK COLOR A1 101/20mm
• 08435288495071: ANAXDENT PMMA DISC U MULTIBLANK COLOR B0 98,5/20mm
• 08435288495026: ANAXDENT PMMA DISC U MULTIBLANK COLOR A3 98,5/20mm
• 08435288495019: ANAXDENT PMMA DISC U MULTIBLANK COLOR A2 98,5/20mm
• 08435288495002: ANAXDENT PMMA DISC U MULTIBLANK COLOR A1 98,5/20mm
• 08435288494357: ANAXDENT PMMA DISC Z MULTI BLANK COLOR B2 98,5/12mm
• 08435288494340: ANAXDENT PMMA DISC Z MULTI BLANK COLOR B1 98,5/12mm
• 08435288494333: ANAXDENT PMMA DISC Z MULTI BLANK COLOR B0 98,5/12mm
• 08435288494319: ANAXDENT PMMA DISC Z MULTI BLANK COLOR A3,5 98,5/12mm