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

Dental Stereotaxic Instrument

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

PLV is the FDA product code for Dental Stereotaxic Instrument, a class II device type, regulated under 21 CFR 872.4120. FDA's definition for this code reads: "To facilitate dental implant placement in patients that are partially endentulous or edentulous". As of , FDA records hold 23 510(k) clearances under this code, the most recent dated , and 6 recalls.

Classification record

Product code
PLV
Device name
Dental Stereotaxic Instrument
FDA definition
To facilitate dental implant placement in patients that are partially endentulous or edentulous.
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
23
Ingested recalls
6

Clearances, product code PLV

By decision year
23 clearances under product code PLV with a decision year between 2015 and 2025, 2020 the highest year at 7.
Show the numbers
510(k) clearances under FDA product code PLV by decision year
YearClearances
20151
20162
20182
20192
20207
20212
20223
20231
20241
20252

Applicants with the most clearances

Product code PLV
Applicants holding the most 510(k) clearances under product code PLV
ApplicantClearances
Neocis Inc.16
ClaroNav Inc.3
X-NAV Technologies, LLC3
Navigate Surgical Technologies Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code