Dispenser, Mercury And/Or Alloy
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.
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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
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.
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.