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

X-Ray, Tomography, Computed, Dental

21 CFR 892.1750 / Radiology
FDA source (opens on fda.gov)

OAS is the FDA product code for X-Ray, Tomography, Computed, Dental, a class II device type, regulated under 21 CFR 892.1750. FDA's definition for this code reads: "Produce cross-sectional diagnostic x-ray images of the intra-oral tissue and teeth". As of , FDA records hold 135 510(k) clearances under this code, the most recent dated , and 7 recalls.

Classification record

Product code
OAS
Device name
X-Ray, Tomography, Computed, Dental
FDA definition
Produce cross-sectional diagnostic x-ray images of the intra-oral tissue and teeth.
Regulation
21 CFR 892.1750
Device class
Class II
Review panel
Radiology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
135
Ingested recalls
7

Clearances, product code OAS

By decision year
135 clearances under product code OAS with a decision year between 2001 and 2026, 2016 the highest year at 12.
Show the numbers
510(k) clearances under FDA product code OAS by decision year
YearClearances
20011
20041
20072
20082
20092
20101
20116
20127
201310
20145
20155
201612
20174
201811
20197
20209
202111
20226
202312
20244
20259
20268

Applicants with the most clearances

Product code OAS
Applicants holding the most 510(k) clearances under product code OAS
ApplicantClearances
Vatech Co., Ltd.19
Palodex Group Oy9
Prexion Corporation9
Ray Co., Ltd.8
Cefla S.C.7
Ray Co., Ltd.5
Genoray Co., Ltd.4
Trophy4
Dentium Co.,Ltd(ict Branch)3
Dentsply Sirona Inc3

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 47 companies shown, in name order