Cleared Traditional

K994060 - THE BIOPLATE RESORBABLE BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY, BIOLACTATE (FDA 510(k) Clearance)

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

K994060 · Bioplate, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2001
Decision
421d
Days
Class 2
Risk

K994060 is an FDA 510(k) clearance for the THE BIOPLATE RESORBABLE BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY, .... 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 January 24, 2001 after a review of 421 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4760 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Dental submissions.

View all Bioplate, Inc. devices

Submission Details

510(k) Number K994060 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 30, 1999
Decision Date January 24, 2001
Days to Decision 421 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
294d slower than avg
Panel avg: 127d · This submission: 421d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 291
Devices cleared under the same product code (JEY) and FDA review panel - the closest regulatory comparables to K994060.
Leforte MMF System
K252246 · Jeil Medical Corporation · Apr 2026
Southern Craniomaxillofacial (CMF) System
K253373 · Southern Medical (Pty) , Ltd. · Dec 2025
Inion CPS 1.5 Baby Bioabsorbable Fixation System
K251441 · Inion OY · Nov 2025
KLS Martin Oral-Max Implants MR Conditional (bundled)
K241314 · KLS-Martin L.P. · Aug 2024
MRI Universal
K240651 · Stryker Leibinger GmbH & Co KG · Jul 2024
tmCMF Solution
K233874 · Techmah Cmf · Jul 2024