Polystar HK 1984402

GUDID D7091984402

anteriors; shade B4; mould 100

Merz Dental GmbH

Resin artificial teeth

• Primary Device ID: D7091984402
• NIH Device Record Key: c300e8bd-3958-4913-8793-d54be2208b27
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Polystar HK
• Version Model Number: anteriors; shade B4; mould 100
• Catalog Number: 1984402
• 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	D7091984402 [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