Mercury
Dental Mercury is elemental mercury used in combination with dental amalgam alloy powder to form a restorative amalgam material for filling posterior tooth cavities; it requires careful handling and disposal due to its toxicological properties. It is classified as FDA Class 2 (moderate risk), requiring 510(k) premarket clearance given material safety considerations. The product code is ELY, regulated under 21 CFR 872.3070 in the Dental (DE) specialty. This device is eligible for third-party review.
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Basic Information
- Product Code
- ELY
- Device Class
- FDA class 2
- Regulation Number
- 872.3070
- Medical Specialty
- Dental
- Review Panel
- DE
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 4 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K093587 | DENTAL MERCURY | Jan 21, 2010 | Substantially Equivalent | Dmg USA, Inc. |
| K973548 | MERCURY DENTAL | Mar 23, 1998 | Substantially Equivalent | Aleaciones Dentales Zeyco, S.A. DE C.V. |
| K913814 | MODEL #05 ANEROID SPHYGMOMANOMETER KIT | Jan 16, 1992 | Substantially Equivalent | National Health-Care Equipment, Inc. |
| K902388 | DENTAL-QUECKSILBER (DENTAL MERCURY) | Jun 28, 1990 | Substantially Equivalent | Degussa AG |
FEI Numbers
This FDA classification entry is associated with 8 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 8 registration numbers. Click on an entry to view related FDA registrations.