integral 1987084

GUDID D7091987084

anteriors; shade A4; mould CL

Merz Dental GmbH

Resin artificial teeth

• Primary Device ID: D7091987084
• NIH Device Record Key: 0cb5a48b-e632-40d3-ad74-b8669fabd0fe
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: integral
• Version Model Number: anteriors; shade A4; mould CL
• Catalog Number: 1987084
• 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	D7091987084 [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: 2017-01-21

On-Brand Devices [integral]

• D7091988159: posteriors; shade BL4; size XS; lower jaw
• D7091988158: posteriors; shade BL4; size XS; upper jaw
• D7091988157: posteriors; shade BL4; size S; lower jaw
• D7091988156: posteriors; shade BL4; size S; upper jaw
• D7091988155: posteriors; shade BL4; size M; lower jaw
• D7091988154: posteriors; shade BL4; size M; upper jaw
• D7091988153: posteriors; shade BL4; size L; lower jaw
• D7091988152: posteriors; shade BL4; size L; upper jaw
• D7091988151: posteriors; shade BL3; size XS; lower jaw
• D7091988150: posteriors; shade BL3; size XS; upper jaw
• D7091988149: posteriors; shade BL3; size S; lower jaw
• D7091988148: posteriors; shade BL3; size S; upper jaw
• D7091988147: posteriors; shade BL3; size M; lower jaw
• D7091988146: posteriors; shade BL3; size M; upper jaw
• D7091988145: posteriors; shade BL3; size L; lower jaw
• D7091988144: posteriors; shade BL3; size L; upper jaw
• D7091988143: posteriors; shade BL2; size XS; lower jaw
• D7091988142: posteriors; shade BL2; size XS; upper jaw
• D7091988141: posteriors; shade BL2; size S; lower jaw
• D7091988140: posteriors; shade BL2; size S; upper jaw
• D7091988139: posteriors; shade BL2; size M; lower jaw
• D7091988138: posteriors; shade BL2; size M; upper jaw
• D7091988137: posteriors; shade BL2; size L; lower jaw
• D7091988136: posteriors; shade BL2; size L; upper jaw
• D7091988135: posteriors; shade BL1; size XS; lower jaw
• D7091988134: posteriors; shade BL1; size XS; upper jaw
• D7091988133: posteriors; shade BL1; size S; lower jaw
• D7091988132: posteriors; shade BL1; size S; upper jaw
• D7091988131: posteriors; shade BL1; size M; lower jaw
• D7091988130: posteriors; shade BL1; size M; upper jaw
• D7091988129: posteriors; shade BL1; size L; lower jaw
• D7091988128: posteriors; shade BL1; size L; upper jaw
• D7091988127: posteriors; shade D4; size XS; lower jaw
• D7091988126: posteriors; shade D4; size XS; upper jaw
• D7091988125: posteriors; shade D4; size S; lower jaw
• D7091988124: posteriors; shade D4; size S; upper jaw
• D7091988123: posteriors; shade D4; size M; lower jaw
• D7091988122: posteriors; shade D4; size M; upper jaw
• D7091988121: posteriors; shade D4; size L; lower jaw
• D7091988120: posteriors; shade D4; size L; upper jaw
• D7091988119: posteriors; shade D3; size XS; lower jaw
• D7091988118: posteriors; shade D3; size XS; upper jaw
• D7091988117: posteriors; shade D3; size S; lower jaw
• D7091988116: posteriors; shade D3; size S; upper jaw
• D7091988115: posteriors; shade D3; size M; lower jaw
• D7091988114: posteriors; shade D3; size M; upper jaw
• D7091988113: posteriors; shade D3; size L; lower jaw
• D7091988112: posteriors; shade D3; size L; upper jaw
• D7091988111: posteriors; shade D2; size XS; lower jaw
• D7091988110: posteriors; shade D2; size XS; upper jaw