Cleared Traditional

K881662 - EXPANDED CLAIMES TO OSTEOGEN(R)

K881662 is an FDA 510(k) clearance for EXPANDED CLAIMES TO OSTEOGEN, manufactured by Impladent. The device is a Class 2 Dental device with product code DZE cleared through the Traditional 510(k) pathway after a 139-day FDA review.

K881662 · Impladent · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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.

View all Impladent devices

FDA 510(k) Submission Details - K881662

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.

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 1319
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K881662.
SURGICAL DRILLS
K891615 · Implant Innovations International, Inc. · Apr 1989
TITANIUM FORCEPS
K891618 · Implant Innovations International, Inc. · Apr 1989
IMZ O-RING ATTACHMENT
K883211 · Interpore Intl. · Nov 1988
INNOVATIVE IMPLANTS AND COVER SCREWS
K874590 · Implant Innovations International, Inc. · May 1988
THE MICRO-VENT/HA
K873255 · Core-Vent Corp. · Mar 1988
NON-ROTATING GOLD CYLINDER AND SCREW
K874400 · Implant Innovations International, Inc. · Mar 1988