DENTAL MERCURY
FDA 510(k) clearance K093587 · decided 2010-01-21
Clearance details
- K-number
- K093587
- Device name
- DENTAL MERCURY
- Applicant
- Dmg USA, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2009-11-19
- Decision date
- 2010-01-21
- Days to decision
- 63 days
- Clearance type
- Traditional
- Product code
- ELY
- Device class
- 2
- Regulation number
- 872.3070
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Attleboro, MA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| MERCURY DENTAL (K973548) | Aleaciones Dentales Zeyco, S.A. DE C.V. | 1998-03-23 |
| MODEL #05 ANEROID SPHYGMOMANOMETER KIT (K913814) | National Health-Care Equipment, Inc. | 1992-01-16 |
| DENTAL-QUECKSILBER (DENTAL MERCURY) (K902388) | Degussa AG | 1990-06-28 |
Recalls involving this device
No recalls on record reference this clearance.