artegral 1970360

GUDID D7091970360

anteriors; shade C4; mould BIS

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 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: D7091970360
• NIH Device Record Key: a8dcdfe3-57b3-40f8-a043-049405f63e61
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: artegral
• Version Model Number: anteriors; shade C4; mould BIS
• Catalog Number: 1970360
• 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	D7091970360 [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