Device Classification Name |
alloy, gold-based noble metal
|
510(k) Number |
K021926 |
Device Name |
AUROPAL 60 |
Applicant |
WIELAND DENTAL + TECHNIK GMBH & CO. KG |
SCHWENNINGER STRABE 13 |
PFORZHEIM,
DE
D-75179
|
|
Applicant Contact |
GERHARD POLZER |
Correspondent |
WIELAND DENTAL + TECHNIK GMBH & CO. KG |
SCHWENNINGER STRABE 13 |
PFORZHEIM,
DE
D-75179
|
|
Correspondent Contact |
GERHARD POLZER |
Regulation Number | 872.3060
|
Classification Product Code |
|
Date Received | 06/12/2002 |
Decision Date | 07/25/2002 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|