artBloc Temp 1017738

GUDID D7091017738

2 artBloc Temp-PMMA-bloc, shade BL1, 15,5x19,0x39,0mm

Merz Dental GmbH

Temporary dental crown/bridge

• Primary Device ID: D7091017738
• NIH Device Record Key: b7ddd560-b4d4-497d-8b5f-97d7d6d778cd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: artBloc Temp
• Version Model Number: 2 artBloc Temp-PMMA-bloc, shade BL1, 15,5x19,0x39,
• Catalog Number: 1017738
• 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
• Phone: +494381403411
• Email: claudia.bobrowski@merz-dental.de

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D7091017738 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K080556

FDA Product Code

• EBG: Crown And Bridge, Temporary, Resin

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: 2021-10-29
• Device Publish Date: 2016-09-24

On-Brand Devices [artBloc Temp]

• D7091017776: 1 artBloc Temp, PMMA-bloc 15,5x19,0x39,0mm shade D4 translucent
• D7091017775: 1 artBloc Temp, PMMA-bloc 15,5x19,0x39,0mm shade D3 translucent
• D7091017774: 1 artBloc Temp, PMMA-bloc 15,5x19,0x39,0mm shade BL4 translucent
• D7091017773: 1 artBloc Temp, PMMA-bloc 15,5x19,0x39,0mm shade BL3 translucent
• D7091017772: 1 artBloc Temp, PMMA-bloc 15,5x19,0x39,0mm shade BL2 translucent
• D7091017771: 1 artBloc Temp, PMMA-bloc 15,5x19,0x39,0mm shade BL1 translucent
• D7091017766: 1 artBloc Temp, PMMA-bloc 15,5x19,0x39,0mm shade D2 translucent
• D7091017765: 1 artBloc Temp, PMMA-bloc 15,5x19,0x39,0mm shade C4 translucent
• D7091017764: 1 artBloc Temp, PMMA-bloc 15,5x19,0x39,0mm shade C3 translucent
• D7091017763: 1 artBloc Temp, PMMA-bloc 15,5x19,0x39,0mm shade C2 translucent
• D7091017748: Sample artBloc Temp - PMMA-bloc, shade B2
• D7091017743: Sample artBloc Temp - PMMA-bloc, shade A2
• D7091017741: 2 artBloc Temp-PMMA-bloc, shade BL4, 15,5x19,0x39,0mm
• D7091017740: 2 artBloc Temp-PMMA-bloc, shade BL3, 15,5x19,0x39,0mm
• D7091017739: 2 artBloc Temp-PMMA-bloc, shade BL2, 15,5x19,0x39,0mm
• D7091017738: 2 artBloc Temp-PMMA-bloc, shade BL1, 15,5x19,0x39,0mm
• D7091017737: 2 artBloc Temp-PMMA-bloc, shade D4, 15,5x19,0x39,0mm
• D7091017736: 2 artBloc Temp-PMMA-bloc, shade D3, 15,5x19,0x39,0mm
• D7091017735: 2 artBloc Temp-PMMA-bloc, shade D2, 15,5x19,0x39,0mm
• D7091017733: 2 artBloc Temp-PMMA-bloc, shade C4, 15,5x19,0x39,0mm
• D7091017732: 2 artBloc Temp-PMMA-bloc, shade C3, 15,5x19,0x39,0mm
• D7091017731: 2 artBloc Temp-PMMA-bloc, shade C2, 15,5x19,0x39,0mm
• D7091017730: 2 artBloc Temp-PMMA-bloc, shade C1, 15,5x19,0x39,0mm
• D7091017729: 2 artBloc Temp-PMMA-bloc, shade B4, 15,5x19,0x39,0mm
• D7091017728: 2 artBloc Temp-PMMA-bloc, shade B3, 15,5x19,0x39,0mm
• D7091017727: 2 artBloc Temp-PMMA-bloc, shade B2, 15,5x19,0x39,0mm
• D7091017726: 2 artBloc Temp-PMMA-bloc, shade B1, 15,5x19,0x39,0mm
• D7091017725: 2 artBloc Temp-PMMA-bloc, shade A4, 15,5x19,0x39,0mm
• D7091017724: 2 artBloc Temp-PMMA-bloc, shade A3,5, 15,5x19,0x39,0mm
• D7091017723: 2 artBloc Temp-PMMA-bloc, shade A3, 15,5x19,0x39,0mm
• D7091017722: 2 artBloc Temp-PMMA-bloc, shade A2, 15,5x19,0x39,0mm
• D7091017721: 2 artBloc Temp-PMMA-bloc, shade A1, 15,5x19,0x39,0mm
• D7091017720: 10 artBloc Temp-PMMA-bloc, shade BL4, 15,5x19,0x39,0mm
• D7091017719: 10 artBloc Temp-PMMA-bloc, shade BL3, 15,5x19,0x39,0mm
• D7091017718: 10 artBloc Temp-PMMA-bloc, shade BL2, 15,5x19,0x39,0mm
• D7091017717: 10 artBloc Temp-PMMA-bloc, shade BL1, 15,5x19,0x39,0mm
• D7091017716: 10 artBloc Temp-PMMA-bloc, shade D4, 15,5x19,0x39,0mm
• D7091017715: 10 artBloc Temp-PMMA-bloc, shade D3, 15,519,0 x39,0mm
• D7091017714: 10 artBloc Temp-PMMA-bloc, shade D2, 15,5x19,0x39,0mm
• D7091017712: 10 artBloc Temp-PMMA-bloc, shade C4, 15,5x19,0x39,0mm
• D7091017711: 10 artBloc Temp-PMMA-bloc, shade C3, 15,5x19,0x39,0mm
• D7091017710: 10 artBloc Temp-PMMA-bloc, shade C2, 15,5x19,0x39,0mm
• D7091017709: 10 artBloc Temp-PMMA-bloc, shade C1, 15,5x19,0x39,0mm
• D7091017708: 10 artBloc Temp-PMMA-bloc, shade B4, 15,5x19,0x39,0mm
• D7091017707: 10 artBloc Temp-PMMA-bloc, shade B3, 15,5x19,0x39,0mm
• D7091017706: 10 artBloc Temp-PMMA-bloc, shade B2, 15,5x19,0x39,0mm
• D7091017705: 10 artBloc Temp-PMMA-bloc, shade B1, 15,5x19,0x39,0mm
• D7091017704: 10 artBloc Temp-PMMA-bloc, shade A4, 15,5x19,0x39,0mm
• D7091017703: 10 artBloc Temp-PMMA-bloc,shade A3,5, 15,5x19,0x39,0mm
• D7091017702: 10 artBloc Temp-PMMA-bloc, shade A3, 15,5x19,0x39,0mm