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U.S. Department of Health and Human Services

Product Classification

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Device dental cement w/out zinc-oxide eugenol as an ulcer covering for pain relief
Regulation Description Dental cement.
Regulation Medical Specialty Dental
Review Panel Dental
Product CodeMZW
Premarket Review Division of Dental and ENT Devices (DHT1B)
Division of Dental and ENT Devices (DHT1B)
Submission Type 510(k)
Regulation Number 872.3275
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting
Eligible
Implanted Device? No
Life-Sustain/Support Device? No
Recognized Consensus Standard
Third Party Review
Accredited Persons
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