FDA 510(k) Application Details - K202909

Device Classification Name	Abutment, Implant, Dental, Endosseous   More FDA Info for this Device
510(K) Number	K202909
Device Name	Abutment, Implant, Dental, Endosseous
Applicant	CreoDent Prosthetics, Ltd. 29 West 30th Street, 11th Floor New York, NY 10001 US Other 510(k) Applications for this Company
Contact	Calvin Shim Other 510(k) Applications for this Contact
Regulation Number	872.3630   More FDA Info for this Regulation Number
Classification Product Code	NHA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/29/2020
Decision Date	04/02/2021
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