Polystar Selection EDITION anteriors for Ceramill FDS of Amann Girrbach 1016026

GUDID D7091016026

anteriors; shade A3,5light; mould BIL2; for Ceramill FDS of Amann Girrbach

Merz Dental GmbH

Resin artificial teeth

• Primary Device ID: D7091016026
• NIH Device Record Key: 02d0fb1d-bafd-4fca-a886-909193c5bf8c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Polystar Selection EDITION anteriors for Ceramill FDS of Amann Girrbach
• Version Model Number: anteriors; shade A3,5light; mould BIL2
• Catalog Number: 1016026
• Company DUNS: 324914910
• Company Name: Merz Dental GmbH
• 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: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +494381403411
• Email: claudia.bobrowski@merz-dental.de
• Phone: +494381403411
• Email: claudia.bobrowski@merz-dental.de
• Phone: +494381403411
• Email: claudia.bobrowski@merz-dental.de
• Phone: +494381403411
• Email: claudia.bobrowski@merz-dental.de
• Phone: +494381403411
• Email: claudia.bobrowski@merz-dental.de
• Phone: +494381403411
• Email: claudia.bobrowski@merz-dental.de
• Phone: +494381403411
• Email: claudia.bobrowski@merz-dental.de
• Phone: +494381403411
• Email: claudia.bobrowski@merz-dental.de
• Phone: +494381403411
• Email: claudia.bobrowski@merz-dental.de
• Phone: +494381403411
• Email: claudia.bobrowski@merz-dental.de
• Phone: +494381403411
• Email: claudia.bobrowski@merz-dental.de
• Phone: +494381403411
• Email: claudia.bobrowski@merz-dental.de
• Phone: +494381403411
• Email: claudia.bobrowski@merz-dental.de
• Phone: +494381403411
• Email: claudia.bobrowski@merz-dental.de
• Phone: +494381403411
• Email: claudia.bobrowski@merz-dental.de
• Phone: +494381403411
• Email: claudia.bobrowski@merz-dental.de
• Phone: +494381403411
• Email: claudia.bobrowski@merz-dental.de
• Phone: +494381403411
• Email: claudia.bobrowski@merz-dental.de
• Phone: +494381403411
• Email: claudia.bobrowski@merz-dental.de
• Phone: +494381403411
• Email: claudia.bobrowski@merz-dental.de
• Phone: +494381403411
• Email: claudia.bobrowski@merz-dental.de
• Phone: +494381403411
• Email: claudia.bobrowski@merz-dental.de
• Phone: +494381403411
• Email: claudia.bobrowski@merz-dental.de
• Phone: +494381403411
• Email: claudia.bobrowski@merz-dental.de
• Phone: +494381403411
• Email: claudia.bobrowski@merz-dental.de
• Phone: +494381403411
• Email: claudia.bobrowski@merz-dental.de
• Phone: +494381403411
• Email: claudia.bobrowski@merz-dental.de
• Phone: +494381403411
• Email: claudia.bobrowski@merz-dental.de
• Phone: +494381403411
• Email: claudia.bobrowski@merz-dental.de
• Phone: +494381403411
• Email: claudia.bobrowski@merz-dental.de
• Phone: +494381403411
• Email: claudia.bobrowski@merz-dental.de
• Phone: +494381403411
• Email: claudia.bobrowski@merz-dental.de
• Phone: +494381403411
• Email: claudia.bobrowski@merz-dental.de
• Phone: +494381403411
• Email: claudia.bobrowski@merz-dental.de
• Phone: +494381403411
• Email: claudia.bobrowski@merz-dental.de
• Phone: +494381403411
• Email: claudia.bobrowski@merz-dental.de
• Phone: +494381403411
• Email: claudia.bobrowski@merz-dental.de
• Phone: +494381403411
• Email: claudia.bobrowski@merz-dental.de
• Phone: +494381403411
• Email: claudia.bobrowski@merz-dental.de
• Phone: +494381403411
• Email: claudia.bobrowski@merz-dental.de
• Phone: +494381403411
• Email: claudia.bobrowski@merz-dental.de
• Phone: +494381403411
• Email: claudia.bobrowski@merz-dental.de
• Phone: +494381403411
• Email: claudia.bobrowski@merz-dental.de
• Phone: +494381403411
• Email: claudia.bobrowski@merz-dental.de
• Phone: +494381403411
• Email: claudia.bobrowski@merz-dental.de
• Phone: +494381403411
• Email: claudia.bobrowski@merz-dental.de
• Phone: +494381403411
• Email: claudia.bobrowski@merz-dental.de
• Phone: +494381403411
• Email: claudia.bobrowski@merz-dental.de
• Phone: +494381403411
• Email: claudia.bobrowski@merz-dental.de
• Phone: +494381403411
• Email: claudia.bobrowski@merz-dental.de
• Phone: +494381403411
• Email: claudia.bobrowski@merz-dental.de
• Phone: +494381403411
• Email: claudia.bobrowski@merz-dental.de
• Phone: +494381403411
• Email: claudia.bobrowski@merz-dental.de
• Phone: +494381403411
• Email: claudia.bobrowski@merz-dental.de
• Phone: +494381403411
• Email: claudia.bobrowski@merz-dental.de
• Phone: +494381403411
• Email: claudia.bobrowski@merz-dental.de

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D7091016026 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K030588

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: 2
• Public Version Date: 2021-12-13
• Device Publish Date: 2018-10-29

On-Brand Devices [Polystar Selection EDITION anteriors for Ceramill FDS of Amann Girrbach]

• D7091016239: anteriors; shade BL4; mould UM4; for Ceramill FDS of Amann Girrbach
• D7091016238: anteriors; shade BL4; mould UM2; for Ceramill FDS of Amann Girrbach
• D7091016237: anteriors; shade BL4; mould UM6; for Ceramill FDS of Amann Girrbach
• D7091016236: anteriors; shade BL4; mould BIL2; for Ceramill FDS of Amann Girrbach
• D7091016235: anteriors; shade BL4; mould BIM6; for Ceramill FDS of Amann Girrbach
• D7091016234: anteriors; shade BL4; mould BM6; for Ceramill FDS of Amann Girrbach
• D7091016233: anteriors;shade BL3; mould UM4; for Ceramill FDS of Amann Girrbach
• D7091016232: anteriors; shade BL3; mould UM2; for Ceramill FDS of Amann Girrbach
• D7091016231: anteriors; shade BL3; mould UM6; for Ceramill FDS of Amann Girrbach
• D7091016230: anteriors; shade BL3; mould BIL2; for Ceramill FDS of Amann Girrbach
• D7091016229: anteriors; shade BL3; mould BIM6; for Ceramill FDS of Amann Girrbach
• D7091016228: anteriors; shade BL3; mould BM6; for Ceramill FDS of Amann Girrbach
• D7091016227: anteriors; shade BL2; mould UM4; for Ceramill FDS of Amann Girrbach
• D7091016226: anteriors; shade BL2; mould UM2; for Ceramill FDS of Amann Girrbach
• D7091016225: anteriors; shade BL2; mould UM6; for Ceramill FDS of Amann Girrbach
• D7091016224: anteriors; shade BL2; mould BIL2; for Ceramill FDS of Amann Girrbach
• D7091016223: anteriors; shade BL2; mould BIM6; for Ceramill FDS of Amann Girrbach
• D7091016222: anteriors; shade BL2; mould BM6; for Ceramill FDS of Amann Girrbach
• D7091016221: anteriors; shade BL1; mould UM4; for Ceramill FDS of Amann Girrbach
• D7091016220: anteriors; shade BL1; mould UM2; for Ceramill FDS of Amann Girrbach
• D7091016099: anteriors; shade BL1; mould UM6; for Ceramill FDS of Amann Girrbach
• D7091016098: anteriors; shade BL1; mould BIL2; for Ceramill FDS of Amann Girrbach
• D7091016097: anteriors; shade BL1; mould BIM6; for Ceramill FDS of Amann Girrbach
• D7091016096: anteriors; shade BL1; mould BM6; for Ceramill FDS of Amann Girrbach
• D7091016095: anteriors; shade D4; mould UM4; for Ceramill FDS of Amann Girrbach
• D7091016094: anteriors; shade D4; mould UM2; for Ceramill FDS of Amann Girrbach
• D7091016093: anteriors; shade D4; mould UM6; for Ceramill FDS of Amann Girrbach
• D7091016092: anteriors; shade D4; mould BIL2; for Ceramill FDS of Amann Girrbach
• D7091016091: anteriors; shade D4; mould BIM6; for Ceramill FDS of Amann Girrbach
• D7091016090: anteriors; shade D4; mould BM6; for Ceramill FDS of Amann Girrbach
• D7091016089: anteriors; shade D3light; mould UM4; for Ceramill FDS of Amann Girrbach
• D7091016088: anteriors; shade D3light; mould UM2; for Ceramill FDS of Amann Girrbach
• D7091016087: anteriors; shade D3light; mould UM6 ; for Ceramill FDS of Amann Girrbach
• D7091016086: anteriors; shade D3light; mould BIL2; for Ceramill FDS of Amann Girrbach
• D7091016085: anteriors; shade D3light; mould BIM6; for Ceramill FDS of Amann Girrbach
• D7091016084: anteriors; shade D3light; mould BM6; for Ceramill FDS of Amann Girrbach
• D7091016083: anteriors; shade D2light; mould UM4; for Ceramill FDS of Amann Girrbach
• D7091016082: anteriors; shade D2light; mould UM2; for Ceramill FDS of Amann Girrbach
• D7091016081: anteriors; shade D2light; mould UM6; for Ceramill FDS of Amann Girrbach
• D7091016080: anteriors; shade D2light; mould BIL2; for Ceramill FDS of Amann Girrbach
• D7091016079: anteriors; shade D2light; mould BIM6; for Ceramill FDS of Amann Girrbach
• D7091016078: anteriors; shade D2light; mould BM6; for Ceramill FDS of Amann Girrbach
• D7091016077: anteriors; shade C4; mould UM4; for Ceramill FDS of Amann Girrbach
• D7091016076: anteriors; shade C4; mould UM2; for Ceramill FDS of Amann Girrbach
• D7091016075: anteriors; shade C4; mould UM6; for Ceramill FDS of Amann Girrbach
• D7091016074: anteriors; shade C4; mould BIL2; for Ceramill FDS of Amann Girrbach
• D7091016073: anteriors; shade C4; mould BIM6; for Ceramill FDS of Amann Girrbach
• D7091016072: anteriors; shade C4; mould BM6; for Ceramill FDS of Amann Girrbach
• D7091016071: anteriors; shade C3; mould UM4; for Ceramill FDS of Amann Girrbach
• D7091016070: anteriors; shade C3; mould UM2; for Ceramill FDS of Amann Girrbach