510(k) K130476

Device
ORTHODONTIC MINISCREW FOR ABSOLUTE ANCHORAGE
Applicant
DENTAL MORELLI
510(k) number
K130476
Product code
OAT  
Decision
Substantially Equivalent (SESE)
Decision date
2014-01-08
Date received
2013-02-25
Regulation
872.3640
Classification name
Implant, Endosseous, Orthodontic
Medical specialty
Dental
Review panel
Dental
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
LILIAN LLULL
Address
18851 NE 29th Ave. 720 Aventura FL US 33180 33180

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON

Legacy Summary

summary

FDA Review

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