DeltaForm 1978042

GUDID D7091978042

anteriors; shade A2; mould I5

Merz Dental GmbH

Resin artificial teeth

• Primary Device ID: D7091978042
• NIH Device Record Key: d773c1e3-d4db-4edf-8fb1-01784bd9bff0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DeltaForm
• Version Model Number: anteriors; shade A2; mould I5
• Catalog Number: 1978042
• 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	D7091978042 [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: 2
• Public Version Date: 2021-12-13
• Device Publish Date: 2018-05-18

On-Brand Devices [DeltaForm]

• D7091979199: posteriors; shade BL4; size XS; lower jaw
• D7091979198: posteriors; shade BL4; size XS; upper jaw
• D7091979197: posteriors; shade BL4; size S; lower jaw
• D7091979196: posteriors; shade BL4; size S; upper jaw
• D7091979195: posteriors; shade BL4; size M; lower jaw
• D7091979194: posteriors; shade BL4; size M; upper jaw
• D7091979193: posteriors; shade BL4; size L; lower jaw
• D7091979192: posteriors; shade BL4; size L; upper jaw
• D7091979191: posteriors; shade BL4; size XL; lower jaw
• D7091979190: posteriors; shade BL4; size XL; upper jaw
• D7091979189: posteriors; shade BL3; size XS; lower jaw
• D7091979188: posteriors; shade BL3; size XS; upper jaw
• D7091979187: posteriors; shade BL3; size S; lower jaw
• D7091979186: posteriors; shade BL3; size S; upper jaw
• D7091979185: posteriors; shade BL3; size M; lower jaw
• D7091979184: posteriors; shade BL3; size M; upper jaw
• D7091979183: posteriors; shade BL3; size L; lower jaw
• D7091979182: posteriors; shade BL3; size L; upper jaw
• D7091979181: posteriors; shade BL3; size XL; lower jaw
• D7091979180: posteriors; shade BL3; size XL; upper jaw
• D7091979179: posteriors; shade BL2; size XS; lower jaw
• D7091979178: posteriors; shade BL2; size XS; upper jaw
• D7091979177: posteriors; shade BL2; size S; lower jaw
• D7091979176: posteriors; shade BL2; size S; upper jaw
• D7091979175: posteriors; shade BL2; size M; lower jaw
• D7091979174: posteriors; shade BL2; size M; upper jaw
• D7091979173: posteriors; shade BL2; size L; lower jaw
• D7091979172: posteriors; shade BL2; size L; upper jaw
• D7091979171: posteriors; shade BL2; size XL; lower jaw
• D7091979170: posteriors; shade BL2; size XL; upper jaw
• D7091979169: posteriors; shade BL1; size XS; lower jaw
• D7091979168: posteriors; shade BL1; size XS; upper jaw
• D7091979167: posteriors; shade BL1; size S; lower jaw
• D7091979166: posteriors; shade BL1; size S; upper jaw
• D7091979165: posteriors; shade BL1; size M; lower jaw
• D7091979164: posteriors; shade BL1; size M; upper jaw
• D7091979163: posteriors; shade BL1; size L; lower jaw
• D7091979162: posteriors; shade BL1; size L; upper jaw
• D7091979161: posteriors; shade BL1; size XL; lower jaw
• D7091979160: posteriors; shade BL1; size XL; upper jaw
• D7091979159: posteriors; shade D4; size XS; lower jaw
• D7091979158: posteriors; shade D4; size XS; upper jaw
• D7091979157: posteriors; shade D4; size S; lower jaw
• D7091979156: posteriors; shade D4; size S; upper jaw
• D7091979155: posteriors; shade D4; size M; lower jaw
• D7091979154: posteriors; shade D4; size M; upper jaw
• D7091979153: posteriors; shade D4; size L; lower jaw
• D7091979152: posteriors; shade D4; size L; upper jaw
• D7091979151: posteriors; shade D4; size XL; lower jaw
• D7091979150: posteriors; shade D4; size XL; upper jaw