510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K891186Substantially Equivalent

Repositionable Bitewing X-Ray Film Holder Kit

Benn Research, Ltd., Stanmore, Middlesex, GB / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K891186 is the FDA 510(k) clearance record for REPOSITIONABLE BITEWING X-RAY FILM HOLDER KIT, a class I device, cleared for Benn Research , Ltd. on under FDA product code EHA (Aligner, Beam, X-Ray). FDA records list one 510(k) clearance for Benn Research , Ltd. As of , FDA records show no recalls naming K891186.

Clearance record

Decision date
Received
(37 days to decision)
Product code
EHA Aligner, Beam, X-Ray
Regulation
21 CFR 872.1820
Device class
Class I
Review panel
Dental
Applicant
Benn Research , Ltd. 2 Pangbourne Dr., Stanmore, Middlesex, GB
Third party review
No

Clearances, product code EHA

Trailing 12 months

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

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