| Device Classification Name |
Implant, Endosseous, Root-Form
|
| 510(k) Number |
K010467 |
| Device Name |
UNIVERSAL DENTAL COPING (UDC) |
| Applicant |
| Paxmed International |
| 4329 Graydon Rd. |
|
San Diego,
CA
92130
|
|
| Applicant Contact |
FLOYD G LARSON |
| Correspondent |
| Paxmed International |
| 4329 Graydon Rd. |
|
San Diego,
CA
92130
|
|
| Correspondent Contact |
FLOYD G LARSON |
| Regulation Number | 872.3640 |
| Classification Product Code |
|
| Date Received | 02/16/2001 |
| Decision Date | 09/28/2001 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Dental
|
| 510k Review Panel |
Dental
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|