Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K973976
Device Classification Name
Material, Tooth Shade, Resin
More FDA Info for this Device
510(K) Number
K973976
Device Name
Material, Tooth Shade, Resin
Applicant
PARKELL, INC.
155 SCHMITT BLVD.
P.O. BOX 376
FARMINGDALE, NY 11735 US
Other 510(k) Applications for this Company
Contact
NELSON J GENDUSA
Other 510(k) Applications for this Contact
Regulation Number
872.3690
More FDA Info for this Regulation Number
Classification Product Code
EBF
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
10/20/1997
Decision Date
12/04/1997
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