Polystar Selection EDITION 1981030

GUDID D7091981030

anteriors; shade A2; mould CM6

Merz Dental GmbH

Resin artificial teeth

• Primary Device ID: D7091981030
• NIH Device Record Key: 52cabec8-6952-4e2e-a78d-1ff91a9e23f2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Polystar Selection EDITION
• Version Model Number: anteriors; shade A2; mould CM6
• Catalog Number: 1981030
• 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	D7091981030 [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: 2016-12-31

On-Brand Devices [Polystar Selection EDITION]

• D7091982199: posteriors; shade D3 light; size S; lower jaw
• D7091982198: posteriors; shade D3 light; size S; upper jaw
• D7091982197: posteriors; shade D3 light; size M; lower jaw
• D7091982196: posteriors; shade D3 light; size M; upper jaw
• D7091982195: posteriors; shade D3 light; size L; lower jaw
• D7091982194: posteriors; shade D3 light; size L; upper jaw
• D7091982193: posteriors; shade D3 light; size XL; lower jaw
• D7091982192: posteriors; shade D3 light; size XL; upper jaw
• D7091982191: posteriors; shade D2 light; size S; lower jaw
• D7091982190: posteriors; shade D2 light; size S; upper jaw
• D7091982189: posteriors; shade D2 light; size M; lower jaw
• D7091982188: posteriors; shade D2 light; size M; upper jaw
• D7091982187: posteriors; shade D2 light; size L; lower jaw
• D7091982186: posteriors; shade D2 light; size L; upper jaw
• D7091982185: posteriors; shade D2 light; size XL; lower jaw
• D7091982184: posteriors; shade D2 light; size XL; upper jaw
• D7091982183: posteriors; shade A3.5 light; size S; lower jaw
• D7091982182: posteriors; shade A3.5 light; size S; upper jaw
• D7091982181: posteriors; shade A3.5 light; size M; lower jaw
• D7091982180: posteriors; shade A3.5 light; size M; upper jaw
• D7091982179: posteriors; shade A3.5 light; size L; lower jaw
• D7091982178: posteriors; shade A3.5 light; size L; upper jaw
• D7091982177: posteriors; shade A3.5 light; size XL; lower jaw
• D7091982176: posteriors; shade A3.5 light; size XL; upper jaw
• D7091982175: posteriors; shade A3 light; size S; lower jaw
• D7091982174: posteriors; shade A3 light; size S; upper jaw
• D7091982173: posteriors; shade A3 light; size M; lower jaw
• D7091982172: posteriors; shade A3 light; size M; upper jaw
• D7091982171: posteriors; shade A3 light; size L; lower jaw
• D7091982170: posteriors; shade A3 light; size L; upper jaw
• D7091982169: posteriors; shade A3 light; size XL; lower jaw
• D7091982168: posteriors; shade A3 light; size XL; upper jaw
• D7091982167: posteriors; shade A2 light; size S; lower jaw
• D7091982166: posteriors; shade A2 light; size S; upper jaw
• D7091982165: posteriors; shade A2 light; size M; lower jaw
• D7091982164: posteriors; shade A2 light; size M; upper jaw
• D7091982163: posteriors; shade A2 light; size L; lower jaw
• D7091982162: posteriors; shade A2 light; size L; upper jaw
• D7091982161: posteriors; shade A2 light; size XL; lower jaw
• D7091982160: posteriors; shade A2 light; size XL; upper jaw
• D7091982159: posteriors; shade BL4; size S; lower jaw
• D7091982158: posteriors; shade BL4; size S; upper jaw
• D7091982157: posteriors; shade BL4; size M; lower jaw
• D7091982156: posteriors; shade BL4; size M; upper jaw
• D7091982155: posteriors; shade BL4; size L; lower jaw
• D7091982154: posteriors; shade BL4; size L; upper jaw
• D7091982153: posteriors; shade BL4; size XL; lower jaw
• D7091982152: posteriors; shade BL4; size XL; upper jaw
• D7091982151: posteriors; shade BL3; size S; lower jaw
• D7091982150: posteriors; shade BL3; size S; upper jaw