Cleared Traditional

K974358 - FRIALIT -2 SCREW

K974358 is an FDA 510(k) clearance for FRIALIT -2 SCREW, manufactured by Friatec AG. The device is a Class 2 Dental device with product code DZE cleared through the Traditional 510(k) pathway after a 83-day FDA review.

K974358 · Friatec AG · Dental device
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Feb 1998
Decision
83d
Days
Class 2
Risk

K974358 is an FDA 510(k) clearance for the FRIALIT -2 SCREW. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Friatec AG (Potomac, US). The FDA issued a Cleared decision on February 10, 1998 after a review of 83 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3640 - 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 Friatec AG devices

FDA 510(k) Submission Details - K974358

510(k) Number K974358 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 19, 1997
Decision Date February 10, 1998
Days to Decision 83 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
44d faster than avg
Panel avg: 127d · This submission: 83d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DZE Device Classification - Class 2, Special Controls

Product Code DZE Implant, Endosseous, Root-form
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3640
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 - DZE Implant, Endosseous, Root-form

All 940
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K974358.
3.25 MM SIMPLER ONE THREADED DENTAL IMPLANT
K974402 · Vancouver Implant Resources, Inc. · Feb 1998
3.25MM SIMPLER ONE PUSHIN DENTAL IMPLANT
K974403 · Vancouver Implant Resources, Inc. · Feb 1998
4.0MM SIMPLER ONE PUSHIN DENTAL IMPLANT
K974404 · Vancouver Implant Resources, Inc. · Feb 1998
FRIALIT-2 CYLINDER
K974359 · Friatec AG · Feb 1998
IMCOR 3.75 AND 5.00MM EXTERNALLY HEXED, SELF TAPPING HA COATED SCREW IMPLANTS WITH COVER SCREW
K974126 · Imcor · Jan 1998
DUAL INTEGRATOR DENTAL IMPLANT ACCESSORIES PARALLEL PIN, DEPTH GAGE, AND SURGICAL RATCHET
K970572 · Implant Integration Systems, Inc. · Jan 1998