FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DENTAL MERCURY
K Number: K093587
·
Decision Jan 21, 2010
Classifications
1
FEI Numbers
8
Registration Numbers
8
Same Product Code
3
Applicant Total
28
Review Days
63
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Basic Information
- Device Name
- DENTAL MERCURY
- K Number
- K093587
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3070
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Dmg USA, Inc.
- Date Received
- November 19, 2009
- Decision Date
- January 21, 2010
- Product Code
- ELY
- Advisory Committee
- Dental
- Review Advisory Committee
- DE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| ELY | Mercury | FDA class 2 | Dental |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (ELY), ordered by most recent decision date.
MERCURY DENTAL
FDA 510(k)
FDA Class 2
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MODEL #05 ANEROID SPHYGMOMANOMETER KIT
FDA 510(k)
FDA Class 2
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DENTAL-QUECKSILBER (DENTAL MERCURY)
FDA 510(k)
FDA Class 2
·Dental
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| K081493 | INFILTRATION KIT | Sep 18, 2008 | Substantially Equivalent |
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