Cleared Traditional

K974280 - ABUTMENT - COMPLETE

K974280 is an FDA 510(k) clearance for ABUTMENT - COMPLETE, manufactured by The Implant Center of the Palm Beaches. The device is a Class 2 Dental device with product code DZE cleared through the Traditional 510(k) pathway after a 107-day FDA review.

K974280 · The Implant Center of the Palm Beaches · Dental device
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Feb 1998
Decision
107d
Days
Class 2
Risk

K974280 is an FDA 510(k) clearance for the ABUTMENT - COMPLETE. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by The Implant Center of the Palm Beaches (N. Palm Beach, US). The FDA issued a Cleared decision on February 20, 1998 after a review of 107 days - within the typical 510(k) review window.

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 The Implant Center of the Palm Beaches devices

FDA 510(k) Submission Details - K974280

510(k) Number K974280 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 05, 1997
Decision Date February 20, 1998
Days to Decision 107 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
20d faster than avg
Panel avg: 127d · This submission: 107d
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 K974280.
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K974403 · Vancouver Implant Resources, Inc. · Feb 1998
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K974404 · Vancouver Implant Resources, Inc. · Feb 1998