CERACAST-V
FDA 510(k) clearance K030416 · decided 2003-04-14
Clearance details
- K-number
- K030416
- Device name
- CERACAST-V
- Applicant
- Mountain Medico, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2003-02-10
- Decision date
- 2003-04-14
- Days to decision
- 63 days
- Clearance type
- Traditional
- Product code
- EJH
- Device class
- 2
- Regulation number
- 872.3710
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Upland, CA, 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 |
|---|---|---|
| BEGOPAL+ (K123929) | Bego Bremer Goldschlaegerei Wilh. Herbst GmbH & CO | 2013-03-14 |
| CONTINUM V (K040180) | Aalba Dent, Inc. | 2004-03-04 |
| CONTINUM (K040179) | Aalba Dent, Inc. | 2004-03-03 |
| VERASOFT ES (K033356) | Aalba Dent, Inc. | 2003-12-30 |
| DREAM BOND, DREAMCAST CHROME, DREAMCAST V, DREAM FLEXICAST, DREAM LITHECAST (K033045) | American Green Dent. Mfg, Inc. | 2003-12-23 |
| 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 |
| 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 |
| JEWEL CAST PLUS (K023502) | Pentron Laboratory Technologies | 2002-12-18 |
Recalls involving this device
No recalls on record reference this clearance.