Dental Devices; Reclassification of Blade-Form Endosseous Dental Implant
other · Food and Drug Administration · Rule · Published 2014-06-18 · Effective 2014-07-18 · 79 FR 34623
Document
Document number
2014-14216
Federal Register citation
79 FR 34623
CFR reference
21 CFR 872
Type
Rule
Action
Final order.
Category
other
Sub-agency
Food and Drug Administration
Publication date
2014-06-18
Effective date
2014-07-18
HHS docket
Docket No. FDA-2012-N-0677
Abstract
The Food and Drug Administration (FDA) is issuing a final order to reclassify the blade-form endosseous dental implant, a preamendments class III device, into class II (special controls). On its own initiative, based on new information, FDA is revising the classification of blade-form endosseous dental implants.