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FDA PRODUCT CODE · CLASS II

OAT — Implant, Endosseous, Orthodontic

It is intended to provide a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth. It is used temporarily and is removed after orthodontic treatment has been completed.

DEVICE CLASS
Class II
REGULATION
21 CFR 872.3640
MEDICAL SPECIALTY
Dental
REVIEW PANEL
DE
✓ Implant— Life-sustaining— GMP-exempt— Third-party review eligible
2
510(K)/PMA CLEARANCES
510k: 2
0
RECALL ENTRIES

Recent clearances

K260268Bernhard Förster GmbH (Bernhard Foerster Ltd.) · 510k2026-05-19
K242944Leone S.P.A. · 510k2025-06-19

Related on SPEQ

Medical devices industry →Medical device quality (ISO 13485) →FDA device clearances →FDA enforcement & recalls →

Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.

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