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Device
mercury
Regulation Description
Dental mercury.
Regulation Medical Specialty
Dental
Review Panel
Dental
Product Code
ELY
Submission Type
510(k)
Regulation Number
872.3700
Device Class
1
GMP Exempt?
No
Recognized Consensus Standards
ISO 24234:2004(E)
Dentistry - Mercury and alloys for dental amalgam - First edition
ISO 7405:2008
Dentistry - Evaluation of biocompatibility of medical devices used in dentistry
Guidance Document
Class II Special Controls Guidance Document: Dental Amalgam, Mercury, and Amalgam Alloy - Guidance for Industry and FDA Staff
Third Party Review
Eligible for
Accredited Persons Program
Accredited Persons
british standards institution
center for measurement standards of industrial
citech
intertek testing services
kema quality b.v.
niom - scandinavian institute of dental materials
regulatory technology services, llc
tuv rheinland of north america, inc.
tuv sud america inc.
underwriters laboratories, inc.
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