510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K161399Substantially Equivalent

Neocis Guidance System

Neocis Inc., Miami FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K161399 is the FDA 510(k) clearance record for Neocis Guidance System, a class II device, cleared for Neocis, Inc. on under FDA product code PLV (Dental Stereotaxic Instrument). FDA's definition for product code PLV reads: "To facilitate dental implant placement in patients that are partially endentulous or edentulous". FDA records list 18 510(k) clearances for Neocis, Inc., from to . As of , FDA records show one recall naming K161399.

Clearance record

Decision date
Received
(216 days to decision)
Product code
PLV Dental Stereotaxic Instrument
Regulation
21 CFR 872.4120
Device class
Class II
Review panel
Dental
Applicant
Neocis, Inc. 2800 Biscayne Blvd., Suite 600, Miami FL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code PLV

Trailing 12 months

FDA records hold no clearances under product code PLV in the trailing twelve months.

FDA records show no clearances under product code PLV in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code PLV, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260