Cleared Traditional

K971575 - BENCHMARK-IV

K971575 is an FDA 510(k) clearance for BENCHMARK-IV, manufactured by J.F. Jelenko & Co., Inc.. The device is a Class 2 Dental device with product code EJT cleared through the Traditional 510(k) pathway after a 58-day FDA review.

K971575 · J.F. Jelenko & Co., Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1997
Decision
58d
Days
Class 2
Risk

K971575 is an FDA 510(k) clearance for the BENCHMARK-IV. Classified as Alloy, Gold-based Noble Metal (product code EJT), Class II - Special Controls.

Submitted by J.F. Jelenko & Co., Inc. (Armonk, US). The FDA issued a Cleared decision on June 4, 1997 after a review of 58 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3060 - 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 J.F. Jelenko & Co., Inc. devices

FDA 510(k) Submission Details - K971575

510(k) Number K971575 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 07, 1997
Decision Date June 04, 1997
Days to Decision 58 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
69d faster than avg
Panel avg: 127d · This submission: 58d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EJT Device Classification - Class 2, Special Controls

Product Code EJT Alloy, Gold-based Noble Metal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3060
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Peers - EJT Alloy, Gold-based Noble Metal

All 551
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