Device Classification Name |
Bone Grafting Material, Animal Source
|
510(k) Number |
K173594 |
Device Name |
Straumann cerabone |
Applicant |
Institut Straumann AG |
Peter Merian Weg 12 |
Basel,
CH
CH-4002
|
|
Applicant Contact |
Christelle Gerspach-Gasser |
Correspondent |
Straumann USA, LLC |
60 Minuteman Road |
Andover,
MA
01801
|
|
Correspondent Contact |
Jennifer M. Jackson |
Regulation Number | 872.3930
|
Classification Product Code |
|
Date Received | 11/21/2017 |
Decision Date | 10/19/2018 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|