510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K920710Substantially Equivalent

Air Medica III

Hinatawada Seimitsu Mfg. Co., Ltd., Austin TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K920710 is the FDA 510(k) clearance record for AIR MEDICA III, a class I device, cleared for Hinatawada Seimitsu Mfg. Co., Ltd. on under FDA product code EIA (Unit, Operative Dental). FDA records list one 510(k) clearance for Hinatawada Seimitsu Mfg. Co., Ltd. As of , FDA records show no recalls naming K920710.

Clearance record

Decision date
Received
(76 days to decision)
Product code
EIA Unit, Operative Dental
Regulation
21 CFR 872.6640
Device class
Class I
Review panel
Dental
Applicant
Hinatawada Seimitsu Mfg. Co., Ltd. 1101 Capital Of Texas Hgwy, S., Austin TX
510(k) summary
Summary
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