Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K202278
Device Classification Name
Implant, Endosseous, Orthodontic
More FDA Info for this Device
510(K) Number
K202278
Device Name
Implant, Endosseous, Orthodontic
Applicant
Bomei Co, Ltd.
4F., No.1492-2, Chunrih Rd., Taoyuan Dist.
Taoyuan City 33051 TW
Other 510(k) Applications for this Company
Contact
Steven Pan
Other 510(k) Applications for this Contact
Regulation Number
872.3640
More FDA Info for this Regulation Number
Classification Product Code
OAT
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
08/11/2020
Decision Date
01/08/2021
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
DE - Dental
Review Advisory Committee
DE - Dental
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact