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FDA 510(k)

REPOSITIONABLE BITEWING X-RAY FILM HOLDER KIT

K-Number: K891186 · 1989-04-12

ApplicantBenn Research , Ltd.
Decision Date1989-04-12
Product CodeEHA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

REPOSITIONABLE BITEWING X-RAY FILM HOLDER KIT is the device name listed in this FDA 510(k) record. The listed applicant is Benn Research , Ltd.. It received FDA 510(k) clearance on 1989-04-12 under 510(k) number K891186. The device is classified under product code EHA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the REPOSITIONABLE BITEWING X-RAY FILM HOLDER KIT?

REPOSITIONABLE BITEWING X-RAY FILM HOLDER KIT is a medical device that received FDA 510(k) clearance on 1989-04-12. The listed applicant is Benn Research , Ltd.. The 510(k) number is K891186.

When did REPOSITIONABLE BITEWING X-RAY FILM HOLDER KIT receive FDA 510(k) clearance?

REPOSITIONABLE BITEWING X-RAY FILM HOLDER KIT received FDA 510(k) clearance on 1989-04-12, under 510(k) number K891186.

Who is the listed applicant for REPOSITIONABLE BITEWING X-RAY FILM HOLDER KIT?

The FDA 510(k) record lists Benn Research , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for REPOSITIONABLE BITEWING X-RAY FILM HOLDER KIT?

The FDA product code for REPOSITIONABLE BITEWING X-RAY FILM HOLDER KIT is EHA.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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