510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K080438Substantially Equivalent

Dental Unit with Chair

North West Medical Instrument (Group) Co., Ltd., Shanghai, CN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K080438 is the FDA 510(k) clearance record for DENTAL UNIT WITH CHAIR, a class I device, cleared for North West Medical Instrument (Group) Co., Ltd. on under FDA product code EIA (Unit, Operative Dental). FDA records list 2 510(k) clearances for North West Medical Instrument (Group) Co., Ltd., from to . As of , FDA records show no recalls naming K080438.

Clearance record

Decision date
Received
(45 days to decision)
Product code
EIA Unit, Operative Dental
Regulation
21 CFR 872.6640
Device class
Class I
Review panel
Dental
Applicant
North West Medical Instrument (Group) Co., Ltd. # 19, Ln. 999, Zhongshan #2 Rd., Shanghai, CN
510(k) summary
Summary PDF
Third party review
Yes

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