INFINITAS MINI-IMPLANT SYSTEM/GUIDANCE SYSTEM

Implant, Endosseous, Orthodontic

D B ORTHODONTICS LTD

The following data is part of a premarket notification filed by D B Orthodontics Ltd with the FDA for Infinitas Mini-implant System/guidance System.

Pre-market Notification Details

Device IDK072086
510k NumberK072086
Device Name:INFINITAS MINI-IMPLANT SYSTEM/GUIDANCE SYSTEM
ClassificationImplant, Endosseous, Orthodontic
Applicant D B ORTHODONTICS LTD RYEFIELD WAY SILSDEN, KEIGHLEY West Yorkshire,  GB Bd20 0ef
ContactAnna M Dyson
CorrespondentAnna M Dyson
D B ORTHODONTICS LTD RYEFIELD WAY SILSDEN, KEIGHLEY West Yorkshire,  GB Bd20 0ef
Product CodeOAT  
CFR Regulation Number872.3640 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-07-30
Decision Date2007-10-26

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.