510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K843557Substantially Equivalent

K-Apatite 20-40 Mesh K-Apatite 40-60

Katecho LLC, Des Moines IA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K843557 is the FDA 510(k) clearance record for K-APATITE 20-40 MESH K-APATITE 40-60, a class II device, cleared for Katecho, Inc. on under FDA product code ELE (Implant, Subperiosteal). FDA records list 26 510(k) clearances for Katecho, Inc., from to . As of , FDA records show no recalls naming K843557.

Clearance record

Decision date
Received
(81 days to decision)
Product code
ELE Implant, Subperiosteal
Regulation
21 CFR 872.3645
Device class
Class II
Review panel
Dental
Applicant
Katecho, Inc. 2302 SW 9th. St., Des Moines IA
Third party review
No

Clearances, product code ELE

Trailing 12 months

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

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