Device Classification Name |
Blade-Form Endosseous Dental Implant
|
510(k) Number |
K981954 |
Device Name |
VARIOUS DENTAL IMPLANTS WITH VARIOUS ABUTMENTS |
Applicant |
HEALTHLINE IMPLANTS, INC. |
832 MARSEILLES-GALION RD W |
MARION,
OH
|
|
Applicant Contact |
WILLIAM SIMMONS |
Correspondent |
HEALTHLINE IMPLANTS, INC. |
832 MARSEILLES-GALION RD W |
MARION,
OH
|
|
Correspondent Contact |
WILLIAM SIMMONS |
Regulation Number | 872.3640
|
Classification Product Code |
|
Date Received | 06/04/1998 |
Decision Date | 01/25/1999 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|