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510(k) K133088

Device
ZX-27
Applicant
M&M DENTAL STUDIO INC
510(k) number
K133088
Product code
EJX  
Decision
Substantially Equivalent (SESE)
Decision date
2015-01-02
Date received
2013-09-30
Regulation
872.3130
Classification name
Anchor, Preformed
Medical specialty
Dental
Review panel
Dental
Device class
1
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
IRVING WIESEN
Address
420 Lexington Ave. Suite 2400 New York NY US 10170 10170

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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