Cleared Traditional

K891186 - REPOSITIONABLE BITEWING X-RAY FILM HOLDER KIT

K891186 is an FDA 510(k) clearance for REPOSITIONABLE BITEWING X-RAY FILM HOLD..., manufactured by Benn Research , Ltd.. The device is a Class 1 Dental device with product code EHA cleared through the Traditional 510(k) pathway after a 37-day FDA review.

K891186 · Benn Research , Ltd. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1989
Decision
37d
Days
Class 1
Risk

K891186 is an FDA 510(k) clearance for the REPOSITIONABLE BITEWING X-RAY FILM HOLDER KIT. Classified as Aligner, Beam, X-ray (product code EHA), Class I - General Controls.

Submitted by Benn Research , Ltd. (Stanmore, Middlesex, GB). The FDA issued a Cleared decision on April 12, 1989 after a review of 37 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.1820 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Benn Research , Ltd. devices

FDA 510(k) Submission Details - K891186

510(k) Number K891186 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 06, 1989
Decision Date April 12, 1989
Days to Decision 37 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
91d faster than avg
Panel avg: 128d · This submission: 37d
Pathway characteristics
Predicate-based equivalence.

EHA Device Classification - Class 1, General Controls

Product Code EHA Aligner, Beam, X-ray
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.1820
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.