510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K923354Substantially Equivalent

Port Opii, Port Opiii

Mobile Dental Equipment Corp., Bellevue WA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K923354 is the FDA 510(k) clearance record for PORT OPII, PORT OPIII, a class I device, cleared for Mobile Dental Equipment Corp. on under FDA product code EIA (Unit, Operative Dental). FDA records list 3 510(k) clearances for Mobile Dental Equipment Corp., from to . As of , FDA records show no recalls naming K923354.

Clearance record

Decision date
Received
(454 days to decision)
Product code
EIA Unit, Operative Dental
Regulation
21 CFR 872.6640
Device class
Class I
Review panel
Dental
Applicant
Mobile Dental Equipment Corp. 16604 SE 17th Pl., Bellevue WA
510(k) summary
Statement
Third party review
No

Clearances, product code EIA

Trailing 12 months
2 clearances under product code EIA in the twelve months to October 2026, November 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code EIA, trailing twelve months
MonthClearances
November 20251
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20261
September 20260
October 20260