510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K972921Substantially Equivalent

Sanko Intraoral Dental X-Ray

Sanko X-Ray Manufacturing Co., Ltd., Virginia Beach VA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K972921 is the FDA 510(k) clearance record for SANKO INTRAORAL DENTAL X-RAY, a class II device, cleared for Sanko X-Ray Manufacturing Co., Ltd. on under FDA product code EHD (Unit, X-Ray, Extraoral With Timer). FDA records list one 510(k) clearance for Sanko X-Ray Manufacturing Co., Ltd. As of , FDA records show no recalls naming K972921.

Clearance record

Decision date
Received
(151 days to decision)
Product code
EHD Unit, X-Ray, Extraoral With Timer
Regulation
21 CFR 872.1800
Device class
Class II
Review panel
Dental
Applicant
Sanko X-Ray Manufacturing Co., Ltd. 904 Kempsville Rd., Suite 103, Virginia Beach VA
510(k) summary
Statement
Third party review
No

Clearances, product code EHD

Trailing 12 months
6 clearances under product code EHD in the twelve months to October 2026, February 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code EHD, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20262
March 20262
April 20260
May 20261
June 20260
July 20260
August 20260
September 20261
October 20260