Polystar Selection EDITION HD 1983053

GUDID D7091983053

posteriors; shade B2; size M; lower jaw

Merz Dental GmbH

Resin artificial teeth

• Primary Device ID: D7091983053
• NIH Device Record Key: 9b7f3b47-abec-477a-a043-7ce8c945bad9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Polystar Selection EDITION HD
• Version Model Number: posteriors; shade B2; size M; lower jaw
• Catalog Number: 1983053
• 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	D7091983053 [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