Cleared Traditional

K852305 - FLEXIROOT

K852305 is an FDA 510(k) clearance for FLEXIROOT, manufactured by Facial Alveodental Implant Rehabilitation, Inc.. The device is a Class 2 Dental device with product code DZE cleared through the Traditional 510(k) pathway after a 140-day FDA review.

K852305 · Facial Alveodental Implant Rehabilitation, Inc. · Dental device
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Oct 1985
Decision
140d
Days
Class 2
Risk

K852305 is an FDA 510(k) clearance for the FLEXIROOT. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Facial Alveodental Implant Rehabilitation, Inc. (Vallejo, US). The FDA issued a Cleared decision on October 16, 1985 after a review of 140 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 Facial Alveodental Implant Rehabilitation, Inc. devices

FDA 510(k) Submission Details - K852305

510(k) Number K852305 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 29, 1985
Decision Date October 16, 1985
Days to Decision 140 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
12d slower than avg
Panel avg: 128d · This submission: 140d
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 1331
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K852305.
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K791237 · Carbomedics, Inc. · Aug 1979