FDA.report

510(k) K100633

Device
INFINITAS MINI-IMPLANT MODEL: DB10-0009, DB10-0010,DB10-0012,DB10-0015,DB10-0016
Applicant
D B ORTHODONTICS LTD
510(k) number
K100633
Product code
OAT  
Decision
Substantially Equivalent (SESE)
Decision date
2010-04-01
Date received
2010-03-05
Regulation
872.3640
Classification name
Implant, Endosseous, Orthodontic
Medical specialty
Dental
Review panel
Dental
Device class
2
Clearance type
Special
Statement or summary
Statement
Third party reviewed
No
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
ANNA DYSON
Address
Ryefield Way Silsden, Keighley West Yorkshire GB BD20 OEF BD20 OEF

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF not indicated by FDA · openFDA JSON

Legacy Summary

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FDA Review

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