Polystar HK 1984683

GUDID D7091984683

anteriors; shade D4; mould Q 58

Merz Dental GmbH

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 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: D7091984683
• NIH Device Record Key: ea8cc33b-e430-4b63-8f4c-4052e2b91c7f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Polystar HK
• Version Model Number: anteriors; shade D4; mould Q 58
• Catalog Number: 1984683
• 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D7091984683 [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: 3
• Public Version Date: 2021-12-13
• Device Publish Date: 2017-01-15

On-Brand Devices [Polystar HK]

• D7091986287: posteriors; shade D4; size 60; lower jaw
• D7091986286: posteriors; shade D4; size 60; upper jaw
• D7091986285: posteriors; shade D4; size 50; lower jaw
• D7091986284: posteriors; shade D4; size 50; upper jaw
• D7091986283: posteriors; shade D4; size 40; lower jaw
• D7091986282: posteriors; shade D4; size 40; upper jaw
• D7091986281: posteriors; shade D4; size 30; lower jaw
• D7091986280: posteriors; shade D4; size 30; upper jaw
• D7091986279: posteriors; shade D4; size 6; lower jaw
• D7091986278: posteriors; shade D4; size 6; upper jaw
• D7091986277: posteriors; shade D4; size 4; lower jaw
• D7091986276: posteriors; shade D4; size 4; upper jaw
• D7091986275: posteriors; shade D4; size 3 S; lower jaw
• D7091986274: posteriors; shade D4; size 3 S; upper jaw
• D7091986273: posteriors; shade D4; size 3; lower jaw
• D7091986272: posteriors; shade D4; size 3; upper jaw
• D7091986271: posteriors; shade D4; size 2; lower jaw
• D7091986270: posteriors; shade D4; size 2; upper jaw
• D7091986269: posteriors; shade D3; size 60; lower jaw
• D7091986268: posteriors; shade D3; size 60; upper jaw
• D7091986267: posteriors; shade D3; size 50; lower jaw
• D7091986266: posteriors; shade D3; size 50; upper jaw
• D7091986265: posteriors; shade D3; size 40; lower jaw
• D7091986264: posteriors; shade D3; size 40; upper jaw
• D7091986263: posteriors; shade D3; size 30; lower jaw
• D7091986262: posteriors; shade D3; size 30; upper jaw
• D7091986261: posteriors; shade D3; size 6; lower jaw
• D7091986260: posteriors; shade D3; size 6; upper jaw
• D7091986259: posteriors; shade D3; size 4; lower jaw
• D7091986258: posteriors; shade D3; size 4; upper jaw
• D7091986257: posteriors; shade D3; size 3 S; lower jaw
• D7091986256: posteriors; shade D3; size 3 S; upper jaw
• D7091986255: posteriors; shade D3; size 3; lower jaw
• D7091986254: posteriors; shade D3; size 3; upper jaw
• D7091986253: posteriors; shade D3; size 2; lower jaw
• D7091986252: posteriors; shade D3; size 2; upper jaw
• D7091986251: posteriors; shade D2; size 60; lower jaw
• D7091986250: posteriors; shade D2; size 60; upper jaw
• D7091986249: posteriors; shade D2; size 50; lower jaw
• D7091986248: posteriors; shade D2; size 50; upper jaw
• D7091986247: posteriors; shade D2; size 40; lower jaw
• D7091986246: posteriors; shade D2; size 40; upper jaw
• D7091986245: posteriors; shade D2; size 30; lower jaw
• D7091986244: posteriors; shade D2; size 30; upper jaw
• D7091986243: posteriors; shade D2; size 6; lower jaw
• D7091986242: posteriors; shade D2; size 6; upper jaw
• D7091986241: posteriors; shade D2; size 4; lower jaw
• D7091986240: posteriors; shade D2; size 4; upper jaw
• D7091986239: posteriors; shade D2; size 3 S; lower jaw
• D7091986238: posteriors; shade D2; size 3 S; upper jaw