Cleared Traditional

K941575 - SMOOTH FIT

K941575 is an FDA 510(k) clearance for SMOOTH FIT, manufactured by Hi-Tec Implants. The device is a Class 2 Dental device with product code DZE cleared through the Traditional 510(k) pathway after a 231-day FDA review.

K941575 · Hi-Tec Implants · Dental device
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Nov 1994
Decision
231d
Days
Class 2
Risk

K941575 is an FDA 510(k) clearance for the SMOOTH FIT. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Hi-Tec Implants (Herzlia, IL). The FDA issued a Cleared decision on November 17, 1994 after a review of 231 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Hi-Tec Implants devices

FDA 510(k) Submission Details - K941575

510(k) Number K941575 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 31, 1994
Decision Date November 17, 1994
Days to Decision 231 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
104d slower than avg
Panel avg: 127d · This submission: 231d
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 1319
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K941575.
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K941620 · Biomet, Inc. · Sep 1994
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K941621 · Biomet, Inc. · Sep 1994