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

Dental Navigation System

21 CFR 872.4120 / Dental
FDA source (opens on fda.gov)

QRY is the FDA product code for Dental Navigation System, a class II device type, regulated under 21 CFR 872.4120. FDA's definition for this code reads: "Intended to provide real-time guidance on the orientation and location of the dental instrument relative to the patient's anatomy for general dentistry procedures". As of , FDA records hold 5 510(k) clearances under this code, the most recent dated , and 3 recalls.

Classification record

Product code
QRY
Device name
Dental Navigation System
FDA definition
Intended to provide real-time guidance on the orientation and location of the dental instrument relative to the patient's anatomy for general dentistry procedures.
Regulation
21 CFR 872.4120
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
No
Ingested clearances
5
Ingested recalls
3

Clearances, product code QRY

By decision year
5 clearances under product code QRY with a decision year between 2022 and 2026, 2022 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code QRY by decision year
YearClearances
20223
20241
20261

Applicants with the most clearances

Product code QRY
Applicants holding the most 510(k) clearances under product code QRY
ApplicantClearances
Neocis Inc.2
X-NAV Technologies, LLC2
X-Nav Technologies, LLC1

Companies listing this code with FDA

Companies whose registered establishments list this code