SUPER 6
FDA 510(k) clearance K002300 · decided 2000-09-26
Clearance details
- K-number
- K002300
- Device name
- SUPER 6
- Applicant
- Dental Alloy Products, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2000-07-28
- Decision date
- 2000-09-26
- Days to decision
- 60 days
- Clearance type
- Traditional
- Product code
- EJH
- Device class
- 2
- Regulation number
- 872.3710
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Compton, CA, US
- Third-party review
- No
- Expedited review
- No
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|---|---|---|
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| WIROBOND C (K032136) | Bego U.S.A. | 2003-09-04 |
| NANO-TICROWN (K031627) | Nano-Write Corp. | 2003-06-11 |
| PD CASTA-H (K030632) | Mountain Medico, Inc. | 2003-05-07 |
| CERACAST-V (K030416) | Mountain Medico, Inc. | 2003-04-14 |
| SUPERBOND (K030161) | American Dent-All, Inc. | 2003-03-17 |
| KAVO EVEREST TITANBLANK (K024214) | Kavo America | 2003-03-12 |
| GOLD CORE PLUS (K023499) | Pentron Laboratory Technologies | 2003-01-13 |
Recalls involving this device
No recalls on record reference this clearance.