510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K901923Substantially Equivalent

Invotec Poly-Mesh Mandibular Tray

Invotec International, Inc., Jacksonville FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K901923 is the FDA 510(k) clearance record for INVOTEC POLY-MESH MANDIBULAR TRAY, a class II device, cleared for Invotec International, Inc. on under FDA product code JAZ (Prosthesis, Facial, Mandibular Implant). FDA records list 16 510(k) clearances for Invotec International, Inc., from to . As of , FDA records show no recalls naming K901923.

Clearance record

Decision date
Received
(184 days to decision)
Product code
JAZ Prosthesis, Facial, Mandibular Implant
Regulation
21 CFR 874.3695
Device class
Class II
Review panel
Ear, Nose, Throat
Applicant
Invotec International, Inc. 11330-1st. John'S Industrial, Jacksonville FL
Third party review
No

Clearances, product code JAZ

Trailing 12 months

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

FDA records show no clearances under product code JAZ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code JAZ, 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