Cleared Traditional

K994060 - THE BIOPLATE RESORBABLE BONE PLATING SY...

K994060 is an FDA 510(k) clearance for THE BIOPLATE RESORBABLE BONE PLATING SY..., manufactured by Bioplate, Inc.. The device is a Class 2 Dental device with product code JEY cleared through the Traditional 510(k) pathway after a 421-day FDA review.

K994060 · Bioplate, Inc. · Dental device
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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

FDA 510(k) Submission Details - K994060

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
Combination Product No
PCCP Authorized No
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.

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 K994060.
CODMAN CRANIOSORB ABSORBABLE FIXATION SYSTEM PURPLE RIVETS
K003549 · Codman & Shurtleff, Inc. · Feb 2001
LORENZ RESORBABLE DISTRACTOR SYSTEM
K002083 · Walter Lorenz Surgical, Inc. · Feb 2001
THE BIOPLATE REGID FIXATION BONE PLATING SYSTEM FOR CRANOMAXILLOFACIAL SURGERY
K002426 · Bioplate, Inc. · Jan 2001
MOLINA ORBITAL MALAR DISTRACTOR
K003883 · KLS-Martin L.P. · Jan 2001
MAXILLARY DISTRACTOR
K003393 · Synthes (Usa) · Jan 2001
SYNTHES (USA) RESORBABLE TACK SYSTEM
K000560 · Synthes (Usa) · Jan 2001