510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K990667Substantially Equivalent

Kls-Martin Temporary Condylar Implant

KLS-Martin L.P., New Port Riche FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K990667 is the FDA 510(k) clearance record for KLS-MARTIN TEMPORARY CONDYLAR IMPLANT, a class II device, cleared for KLS-Martin L.P. on under FDA product code NEI (Prosthesis, Condyle, Mandibular, Temporary). FDA records list 78 510(k) clearances for KLS-Martin L.P., from to . As of , FDA records show no recalls naming K990667.

Clearance record

Decision date
Received
(878 days to decision)
Product code
NEI Prosthesis, Condyle, Mandibular, Temporary
Regulation
21 CFR 872.4770
Device class
Class II
Review panel
Dental
Applicant
KLS-Martin L.P. 3234 Ella Ln., New Port Riche FL
510(k) summary
Summary
Third party review
No

Clearances, product code NEI

Trailing 12 months

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

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