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
K902287Substantially Equivalent

Rastronics Portarem 20

Rastronics USA, Inc., Indianapolis IN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K902287 is the FDA 510(k) clearance record for RASTRONICS PORTAREM 20, a class II device, cleared for Rastronics USA, Inc. on under FDA product code EJT (Alloy, Gold-Based Noble Metal). FDA records list 5 510(k) clearances for Rastronics USA, Inc., from to . As of , FDA records show no recalls naming K902287.

Clearance record

Decision date
Received
(79 days to decision)
Product code
EJT Alloy, Gold-Based Noble Metal
Regulation
21 CFR 872.3060
Device class
Class II
Review panel
Dental
Applicant
Rastronics USA, Inc. 5407 W. 79th St., Indianapolis IN
Third party review
No

Clearances, product code EJT

Trailing 12 months

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

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