Device Classification Name |
Plugger, Root Canal, Endodontic
|
510(k) Number |
K031664 |
Device Name |
ELEMENTS OBTURATION UNIT |
Applicant |
SYBRON ENDO/ANALYTIC |
15233 N.E. 90TH ST. |
REDMOND,
WA
98052
|
|
Applicant Contact |
COLLEEN BOSWELL |
Correspondent |
SYBRON ENDO/ANALYTIC |
15233 N.E. 90TH ST. |
REDMOND,
WA
98052
|
|
Correspondent Contact |
COLLEEN BOSWELL |
Regulation Number | 872.4565
|
Classification Product Code |
|
Date Received | 05/29/2003 |
Decision Date | 04/28/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|