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510(k) K172398

Device
DENTCA DENTURE Teeth
Applicant
DENTCA, INC.
510(k) number
K172398
Product code
PZY  
Decision
Substantially Equivalent (SESE)
Decision date
2017-11-22
Date received
2017-08-08
Regulation
872.3590
Classification name
Additively Manufactured, Preformed, Resin Denture Tooth
Medical specialty
Dental
Review panel
Dental
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
Jason Lee
Address
357 Van Ness Way, Suite 250 Torrance CA US 90501 90501

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Legacy Summary#

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FDA Review#

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