Cleared Special

K023810 - MODIFICATION TO BIOPLATE RIGID FIXATION...

K023810 is an FDA 510(k) clearance for MODIFICATION TO BIOPLATE RIGID FIXATION..., manufactured by Bioplate, Inc.. The device is a Class 2 Dental device with product code JEY cleared through the Special 510(k) pathway after a 19-day FDA review.

K023810 · Bioplate, Inc. · Dental device
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Dec 2002
Decision
19d
Days
Class 2
Risk

K023810 is an FDA 510(k) clearance for the MODIFICATION TO BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLO.... Classified as Plate, Bone (product code JEY), Class II - Special Controls.

Submitted by Bioplate, Inc. (Los Angeles, US). The FDA issued a Cleared decision on December 4, 2002 after a review of 19 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4760 - the FDA dental device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Bioplate, Inc. devices

FDA 510(k) Submission Details - K023810

510(k) Number K023810 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 15, 2002
Decision Date December 04, 2002
Days to Decision 19 days
Submission Type Special
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
108d faster than avg
Panel avg: 127d · This submission: 19d
Pathway characteristics
Modification to existing cleared device.

JEY Device Classification - Class 2, Special Controls

Product Code JEY Plate, Bone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.4760
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 - JEY Plate, Bone

All 193
Devices cleared under the same product code (JEY) and FDA review panel - the closest regulatory comparables to K023810.
BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY
K030806 · Bioplate, Inc. · Apr 2003
SYNTHES RESORBABLE CONTOURABLE MESH
K022844 · Synthes (Usa) · Jan 2003
UNIVERSAL CMF SYSTEM
K022185 · Stryker Instruments · Dec 2002
MODIFICATION TO BIOPLATE RIGID BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY
K023665 · Bioplate, Inc. · Nov 2002
SYNTHES LOW PROFILE NEURO SYSTEM
K022012 · Synthes (Usa) · Nov 2002
SYNTHES (USA) RESORBABLE FIXATION SYSTEM
K021928 · Synthes (Usa) · Sep 2002