510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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OYHClass II

Orthodontic Vibratory Accessory

21 CFR 872.5470 / Dental
FDA source (opens on fda.gov)

OYH is the FDA product code for Orthodontic Vibratory Accessory, a class II device type, regulated under 21 CFR 872.5470. FDA's definition for this code reads: "An orthodontic accessory intended for use during orthodontic treatment. It is used in conjunction with orthodontic appliances such as braces and helps facilitate minor anterior tooth movement". As of , FDA records hold 5 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
OYH
Device name
Orthodontic Vibratory Accessory
FDA definition
An orthodontic accessory intended for use during orthodontic treatment. It is used in conjunction with orthodontic appliances such as braces and helps facilitate minor anterior tooth movement.
Regulation
21 CFR 872.5470
Device class
Class II
Review panel
Dental
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
5
Ingested recalls
0

Clearances, product code OYH

By decision year
5 clearances under product code OYH with a decision year between 2011 and 2019, 2011 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code OYH by decision year
YearClearances
20111
20131
20161
20171
20191

Applicants with the most clearances

Product code OYH
Applicants holding the most 510(k) clearances under product code OYH
ApplicantClearances
Orthoaccel Technologies, Inc.3
Orthoaccel Technology, Inc.1
Propel Orthodontics, LLC1

Companies listing this code with FDA

Companies whose registered establishments list this code