510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K902531Substantially Equivalent

Exaphase, Single Phase Impression Material

G-C Intl. Corp., Scottsdale AZ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K902531 is the FDA 510(k) clearance record for EXAPHASE, SINGLE PHASE IMPRESSION MATERIAL, a class II device, cleared for G-C Intl. Corp. on under FDA product code EGW (Dryer, Film, Radiographic). FDA records list 23 510(k) clearances for G-C Intl. Corp., from to . As of , FDA records show no recalls naming K902531.

Clearance record

Decision date
Received
(38 days to decision)
Product code
EGW Dryer, Film, Radiographic
Regulation
21 CFR 892.1900
Device class
Class II
Review panel
Radiology
Applicant
G-C Intl. Corp. 7830 E.Redfield Rd. Suite 12, Scottsdale AZ
Third party review
No

Clearances, product code EGW

Trailing 12 months

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

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