Cleared Traditional

EXPANDED CLAIMES TO OSTEOGEN(R) (K881662) - FDA 510(k) Clearance

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K881662 · Impladent · Dental device
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Sep 1988
Decision
139d
Days
Class 2
Risk

K881662 is an FDA 510(k) clearance for the EXPANDED CLAIMES TO OSTEOGEN(R). Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Impladent (Hollis, US). The FDA issued a Cleared decision on September 1, 1988 after a review of 139 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.

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Submission Details

510(k) Number K881662 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received April 15, 1988
Decision Date September 01, 1988
Days to Decision 139 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: 127d · This submission: 139d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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.