Cleared Traditional

K922779 - IMPLANT-PROPHY & PLASTIC DENTAL INSTRUMENT SYSTEM

K922779 is an FDA 510(k) clearance for IMPLANT-PROPHY & PLASTIC DENTAL INSTRUM..., manufactured by Advanced Implant Technologies, Inc.. The device is a Class 2 Dental device with product code DZE cleared through the Traditional 510(k) pathway after a 233-day FDA review.

K922779 · Advanced Implant Technologies, Inc. · Dental device
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Jan 1993
Decision
233d
Days
Class 2
Risk

K922779 is an FDA 510(k) clearance for the IMPLANT-PROPHY & PLASTIC DENTAL INSTRUMENT SYSTEM. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Advanced Implant Technologies, Inc. (Beverly Hills, US). The FDA issued a Cleared decision on January 28, 1993 after a review of 233 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 Advanced Implant Technologies, Inc. devices

FDA 510(k) Submission Details - K922779

510(k) Number K922779 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 09, 1992
Decision Date January 28, 1993
Days to Decision 233 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
106d slower than avg
Panel avg: 127d · This submission: 233d
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 1321
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