Product Code: EHE FDA class 1 21 CFR 872.3080

Dispenser, Mercury And/Or Alloy

Dental

The Mercury and/or Alloy Dispenser is a dental device used to measure and dispense precise quantities of dental amalgam components, specifically mercury and alloy powder, for mixing into amalgam restorative material. It is classified as FDA Class 1 (lowest risk), subject only to general controls. The product code is EHE, regulated under 21 CFR 872.3080 in the Dental (DE) specialty.

510(k)s
2
FEI Numbers
4
Registration Numbers
4
Unique Applicants
2
Years Active
0

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Basic Information

Product Code
EHE
Device Class
FDA class 1
Regulation Number
872.3080
Medical Specialty
Dental
Review Panel
DE
Submission Type
4

Device Characteristics

GMP Exempt
Implant
Life Sustain/Support
Third Party
Summary Malfunction Reporting

510(k) Clearance History

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Related 510(k) Clearances

This FDA classification is associated with 2 510(k) clearances via K numbers.

K Number Device Name
K771749 AMALGAM DISPENSER
K771396 DISPENSER, MERCURY & TABLET/POWDER

FEI Numbers

This FDA classification entry is associated with 4 FEI numbers. Click on an entry to view related FDA registrations.

Registration Numbers

This FDA classification entry is associated with 4 registration numbers. Click on an entry to view related FDA registrations.