artegral HD 1973061

GUDID D7091973061

posteriors; shade B2; size XL; lower jaw

Merz Dental GmbH

Resin artificial teeth

• Primary Device ID: D7091973061
• NIH Device Record Key: 7161cc62-e2a4-4d34-975c-68f1337973f0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: artegral HD
• Version Model Number: posteriors; shade B2; size XL; lower jaw
• Catalog Number: 1973061
• 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	D7091973061 [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: 2016-12-31

On-Brand Devices [artegral HD]

• D7091973199: posteriors; shade BL4; size XS; lower jaw
• D7091973198: posteriors; shade BL4; size XS; upper jaw
• D7091973197: posteriors; shade BL4; size S; lower jaw
• D7091973196: posteriors; shade BL4; size S; upper jaw
• D7091973195: posteriors; shade BL4; size M; lower jaw
• D7091973194: posteriors; shade BL4; size M; upper jaw
• D7091973193: posteriors; shade BL4; size L; lower jaw
• D7091973192: posteriors; shade BL4; size L; upper jaw
• D7091973191: posteriors; shade BL4; size XL; lower jaw
• D7091973190: posteriors; shade BL4; size XL; upper jaw
• D7091973189: posteriors; shade BL3; size XS; lower jaw
• D7091973188: posteriors; shade BL3; size XS; upper jaw
• D7091973187: posteriors; shade BL3; size S; lower jaw
• D7091973186: posteriors; shade BL3; size S; upper jaw
• D7091973185: posteriors; shade BL3; size M; lower jaw
• D7091973184: posteriors; shade BL3; size M; upper jaw
• D7091973183: posteriors; shade BL3; size L; lower jaw
• D7091973182: posteriors; shade BL3; size L; upper jaw
• D7091973181: posteriors; shade BL3; size XL; lower jaw
• D7091973180: posteriors; shade BL3; size XL; upper jaw
• D7091973179: posteriors; shade BL2; size XS; lower jaw
• D7091973178: posteriors; shade BL2; size XS; upper jaw
• D7091973177: posteriors; shade BL2; size S; lower jaw
• D7091973176: posteriors; shade BL2; size S; upper jaw
• D7091973175: posteriors; shade BL2; size M; lower jaw
• D7091973174: posteriors; shade BL2; size M; upper jaw
• D7091973173: posteriors; shade BL2; size L; lower jaw
• D7091973172: posteriors; shade BL2; size L; upper jaw
• D7091973171: posteriors; shade BL2; size XL; lower jaw
• D7091973170: posteriors; shade BL2; size XL; upper jaw
• D7091973169: posteriors; shade BL1; size XS; lower jaw
• D7091973168: posteriors; shade BL1; size XS; upper jaw
• D7091973167: posteriors; shade BL1; size S; lower jaw
• D7091973166: posteriors; shade BL1; size S; upper jaw
• D7091973165: posteriors; shade BL1; size M; lower jaw
• D7091973164: posteriors; shade BL1; size M; upper jaw
• D7091973163: posteriors; shade BL1; size L; lower jaw
• D7091973162: posteriors; shade BL1; size L; upper jaw
• D7091973161: posteriors; shade BL1; size XL; lower jaw
• D7091973160: posteriors; shade BL1; size XL; upper jaw
• D7091973159: posteriors; shade D4; size XS; lower jaw
• D7091973158: posteriors; shade D4; size XS; upper jaw
• D7091973157: posteriors; shade D4; size S; lower jaw
• D7091973156: posteriors; shade D4; size S; upper jaw
• D7091973155: posteriors; shade D4; size M; lower jaw
• D7091973154: posteriors; shade D4; size M; upper jaw
• D7091973153: posteriors; shade D4; size L; lower jaw
• D7091973152: posteriors; shade D4; size L; upper jaw
• D7091973151: posteriors; shade D4; size XL; lower jaw
• D7091973150: posteriors; shade D4; size XL; upper jaw