| Device Classification Name |
powder, porcelain
|
|---|
| 510(k) Number |
K081253 |
|---|
| Device Name |
ZIRDENT CAD/CAM BLOCKS |
|---|
| Applicant |
| C5 MEDICAL WERKS, INC. |
| 2451 RIVER RD. |
|
GRAND JUNCTION,
CO
81505
|
|
| Applicant Contact |
HOMER GREGORY |
| Correspondent |
| INTERTEK TESTING SERVICES |
| 2307 EAST AURORA ROAD |
| UNIT B7 |
|
TWINSBURG,
OH
44087
|
|
| Correspondent Contact |
DANIEL W LEHTONEN |
| Regulation Number | 872.6660
|
|---|
| Classification Product Code |
|
|---|
| Date Received | 05/02/2008 |
|---|
| Decision Date | 05/15/2008 |
|---|
| Decision |
Substantially Equivalent
(SESE) |
|---|
| Regulation Medical Specialty |
Dental
|
|---|
| 510k Review Panel |
Dental
|
|---|
| Summary |
Summary
|
| Type |
Traditional
|
|---|
| Reviewed by Third Party |
Yes
|
|---|
| Combination Product |
No
|
|---|