Cleared Special

K051845 - THE BIOPLATE RESORBABLE ENDOBROW FIXATI...

K051845 is an FDA 510(k) clearance for THE BIOPLATE RESORBABLE ENDOBROW FIXATI..., 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 20-day FDA review.

K051845 · Bioplate, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2005
Decision
20d
Days
Class 2
Risk

K051845 is an FDA 510(k) clearance for the THE BIOPLATE RESORBABLE ENDOBROW FIXATION SYSTEM. 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 July 27, 2005 after a review of 20 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 - K051845

510(k) Number K051845 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 07, 2005
Decision Date July 27, 2005
Days to Decision 20 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
107d faster than avg
Panel avg: 127d · This submission: 20d
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 K051845.
AESCULAP CRANIOFACIAL PLATE AND SCREW
K060492 · Aesculap, Inc. · Apr 2006
INION CPS BABY 1.5 BIOABSORBABLE FIXATION SYSTEM
K052444 · Inion , Ltd. · Sep 2005
RESORB-X SF
K051236 · KLS-Martin L.P. · Aug 2005
INION CPS BABY 1.5 BIOABSORBABLE FIXATION SYSTEM, 40 AND 64 HOLE PLATES, MODELS PLT-1058 AND PLT-1059
K051341 · Inion , Ltd. · May 2005
JEIL BONE FIXATION SYSTEM
K050669 · Jeil Medical Corporation · May 2005
SYNTHES CARNIOFACIAL PLATE AND SCREW SYSTEM
K050608 · Synthes (Usa) · May 2005