Cleared Traditional

K981141 - SARGON IMMEDIATE LOAD IMPLANT, MODEL D

K981141 is an FDA 510(k) clearance for SARGON IMMEDIATE LOAD IMPLANT, manufactured by Sargon Ent., Inc.. The device is a Class 2 Dental device with product code DZE cleared through the Traditional 510(k) pathway after a 450-day FDA review.

K981141 · Sargon Ent., Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1999
Decision
450d
Days
Class 2
Risk

K981141 is an FDA 510(k) clearance for the SARGON IMMEDIATE LOAD IMPLANT, MODEL D. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Sargon Ent., Inc. (Washington, US). The FDA issued a Cleared decision on June 23, 1999 after a review of 450 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Dental submissions.

View all Sargon Ent., Inc. devices

FDA 510(k) Submission Details - K981141

510(k) Number K981141 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 30, 1998
Decision Date June 23, 1999
Days to Decision 450 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
323d slower than avg
Panel avg: 127d · This submission: 450d
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 922
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