Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K191590
Device Classification Name
Crown And Bridge, Temporary, Resin
More FDA Info for this Device
510(K) Number
K191590
Device Name
Crown And Bridge, Temporary, Resin
Applicant
Enlighten Materials Co., Ltd
8F., NO.138, Sec.2, Jinshan S. Rd., Da-an Dist
Taipei 10642 TW
Other 510(k) Applications for this Company
Contact
Jiun Ming Su
Other 510(k) Applications for this Contact
Regulation Number
872.3770
More FDA Info for this Regulation Number
Classification Product Code
EBG
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
06/14/2019
Decision Date
05/05/2020
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
DE - Dental
Review Advisory Committee
DE - Dental
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact