Cleared Traditional

X-BEAM FILM 3TC (K833592) - FDA 510(k) Clearance

K833592 · Amorient Ent. · Dental device
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Dec 1983
Decision
76d
Days
-
Risk

K833592 is an FDA 510(k) clearance for the X-BEAM FILM 3TC.

Submitted by Amorient Ent. (Mchenry, US). The FDA issued a Cleared decision on December 27, 1983 after a review of 76 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel. 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 Amorient Ent. devices

Submission Details

510(k) Number K833592 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 12, 1983
Decision Date December 27, 1983
Days to Decision 76 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
51d faster than avg
Panel avg: 127d · This submission: 76d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -