Polystar Selection EDITION HD 1983114

GUDID D7091983114

posteriors; shade D3; size L; upper jaw

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

• Primary Device ID: D7091983114
• NIH Device Record Key: 3bc440a8-5ed5-4399-803e-a130f1392c86
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Polystar Selection EDITION HD
• Version Model Number: posteriors; shade D3; size L; upper jaw
• Catalog Number: 1983114
• 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D7091983114 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K120404

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: 2017-01-06

On-Brand Devices [Polystar Selection EDITION HD]

• D7091983159: posteriors; shade BL4; size S; lower jaw
• D7091983158: posteriors; shade BL4; size S; upper jaw
• D7091983157: posteriors; shade BL4; size M; lower jaw
• D7091983156: posteriors; shade BL4; size M; upper jaw
• D7091983155: posteriors; shade BL4; size L; lower jaw
• D7091983154: posteriors; shade BL4; size L; upper jaw
• D7091983153: posteriors; shade BL4; size XL; lower jaw
• D7091983152: posteriors; shade BL4; size XL; upper jaw
• D7091983151: posteriors; shade BL3; size S; lower jaw
• D7091983150: posteriors; shade BL3; size S; upper jaw
• D7091983149: posteriors; shade BL3; size M; lower jaw
• D7091983148: posteriors; shade BL3; size M; upper jaw
• D7091983147: posteriors; shade BL3; size L; lower jaw
• D7091983146: posteriors; shade BL3; size L; upper jaw
• D7091983145: posteriors; shade BL3; size XL; lower jaw
• D7091983144: posteriors; shade BL3; size XL; upper jaw
• D7091983143: posteriors; shade BL2; size S; lower jaw
• D7091983142: posteriors; shade BL2; size S; upper jaw
• D7091983141: posteriors; shade BL2; size M; lower jaw
• D7091983140: posteriors; shade BL2; size M; upper jaw
• D7091983139: posteriors; shade BL2; size L; lower jaw
• D7091983138: posteriors; shade BL2; size L; upper jaw
• D7091983137: posteriors; shade BL2; size XL; lower jaw
• D7091983136: posteriors; shade BL2; size XL; upper jaw
• D7091983135: posteriors; shade BL1; size S; lower jaw
• D7091983134: posteriors; shade BL1; size S; upper jaw
• D7091983133: posteriors; shade BL1; size M; lower jaw
• D7091983132: posteriors; shade BL1; size M; upper jaw
• D7091983131: posteriors; shade BL1; size L; lower jaw
• D7091983130: posteriors; shade BL1; size L; upper jaw
• D7091983129: posteriors; shade BL1; size XL; lower jaw
• D7091983128: posteriors; shade BL1; size XL; upper jaw
• D7091983127: posteriors; shade D4; size S; lower jaw
• D7091983126: posteriors; shade D4; size S; upper jaw
• D7091983125: posteriors; shade D4; size M; lower jaw
• D7091983124: posteriors; shade D4; size M; upper jaw
• D7091983123: posteriors; shade D4; size L; lower jaw
• D7091983122: posteriors; shade D4; size L; upper jaw
• D7091983121: posteriors; shade D4; size XL; lower jaw
• D7091983120: posteriors; shade D4; size XL; upper jaw
• D7091983119: posteriors; shade D3; size S; lower jaw
• D7091983118: posteriors; shade D3; size S; upper jaw
• D7091983117: posteriors; shade D3; size M; lower jaw
• D7091983116: posteriors; shade D3; size M; upper jaw
• D7091983115: posteriors; shade D3; size L; lower jaw
• D7091983114: posteriors; shade D3; size L; upper jaw
• D7091983113: posteriors; shade D3; size XL; lower jaw
• D7091983112: posteriors; shade D3; size XL; upper jaw
• D7091983111: posteriors; shade D2; size S; lower jaw
• D7091983110: posteriors; shade D2; size S; upper jaw