artegral 1970740

GUDID D7091970740

anteriors; shade D4; mould IXL

Merz Dental GmbH

Resin artificial teeth

• Primary Device ID: D7091970740
• NIH Device Record Key: 76776b73-d4bd-4431-859c-07e4bc9f3420
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: artegral
• Version Model Number: anteriors; shade D4; mould IXL
• Catalog Number: 1970740
• 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	D7091970740 [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 [artegral]

• D7091972249: posteriors; shade D3 light; size XS; lower jaw
• D7091972248: posteriors; shade D3 light; size XS; upper jaw
• D7091972247: posteriors; shade D3 light; size S; lower jaw
• D7091972246: posteriors; shade D3 light; size S; upper jaw
• D7091972245: posteriors; shade D3 light; size M; lower jaw
• D7091972244: posteriors; shade D3 light; size M; upper jaw
• D7091972243: posteriors; shade D3 light; size L; lower jaw
• D7091972242: posteriors; shade D3 light; size L; upper jaw
• D7091972241: posteriors; shade D3 light; size XL; lower jaw
• D7091972240: posteriors; shade D3 light; size XL; upper jaw
• D7091972239: posteriors; shade D2 light; size XS; lower jaw
• D7091972238: posteriors; shade D2 light; size XS; upper jaw
• D7091972237: posteriors; shade D2 light; size S; lower jaw
• D7091972236: posteriors; shade D2 light; size S; upper jaw
• D7091972235: posteriors; shade D2 light; size M; lower jaw
• D7091972234: posteriors; shade D2 light; size M; upper jaw
• D7091972233: posteriors; shade D2 light; size L; lower jaw
• D7091972232: posteriors; shade D2 light; size L; upper jaw
• D7091972231: posteriors; shade D2 light; size XL; lower jaw
• D7091972230: posteriors; shade D2 light; size XL; upper jaw
• D7091972229: posteriors; shade A3.5 light; size XS; lower jaw
• D7091972228: posteriors; shade A3.5 light; size XS; upper jaw
• D7091972227: posteriors; shade A3.5 light; size S; lower jaw
• D7091972226: posteriors; shade A3.5 light; size S; upper jaw
• D7091972225: posteriors; shade A3.5 light; size M; lower jaw
• D7091972224: posteriors; shade A3.5 light; size M; upper jaw
• D7091972223: posteriors; shade A3.5 light; size L; lower jaw
• D7091972222: posteriors; shade A3.5 light; size L; upper jaw
• D7091972221: posteriors; shade A3.5 light; size XL; lower jaw
• D7091972220: posteriors; shade A3.5 light; size XL; upper jaw
• D7091972219: posteriors; shade A3 light; size XS; lower jaw
• D7091972218: posteriors; shade A3 light; size XS; upper jaw
• D7091972217: posteriors; shade A3 light; size S; lower jaw
• D7091972216: posteriors; shade A3 light; size S; upper jaw
• D7091972215: posteriors; shade A3 light; size M; lower jaw
• D7091972214: posteriors; shade A3 light; size M; upper jaw
• D7091972213: posteriors; shade A3 light; size L; lower jaw
• D7091972212: posteriors; shade A3 light; size L; upper jaw
• D7091972211: posteriors; shade A3 light; size XL; lower jaw
• D7091972210: posteriors; shade A3 light; size XL; upper jaw
• D7091972209: posteriors; shade A2 light; size XS; lower jaw
• D7091972208: posteriors; shade A2 light; size XS; upper jaw
• D7091972207: posteriors; shade A2 light; size S; lower jaw
• D7091972206: posteriors; shade A2 light; size S; upper jaw
• D7091972205: posteriors; shade A2 light; size M; lower jaw
• D7091972204: posteriors; shade A2 light; size M; upper jaw
• D7091972203: posteriors; shade A2 light; size L; lower jaw
• D7091972202: posteriors; shade A2 light; size L; upper jaw
• D7091972201: posteriors; shade A2 light; size XL; lower jaw
• D7091972200: posteriors; shade A2 light; size XL; upper jaw