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
K980783Substantially Equivalent

Simplex Saliva Absorber/collector, Model Ssa-5

Irt Management Corp., Hallandale FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K980783 is the FDA 510(k) clearance record for SIMPLEX SALIVA ABSORBER/COLLECTOR, MODEL SSA-5, a class I device, cleared for Irt Management Corp. on under FDA product code KHR (Absorber, Saliva, Paper). FDA records list 2 510(k) clearances for Irt Management Corp., from to . As of , FDA records show no recalls naming K980783.

Clearance record

Decision date
Received
(50 days to decision)
Product code
KHR Absorber, Saliva, Paper
Regulation
21 CFR 872.6050
Device class
Class I
Review panel
Dental
Applicant
Irt Management Corp. 470 Ansin Blvd., Suite G, Hallandale FL
510(k) summary
Statement
Third party review
No

Clearances, product code KHR

Trailing 12 months

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

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