Cleared Traditional

K952811 - 3I ORAL/MAXILLOFACIAL BONE FIXATION SYSTEM: STAINLESS STEEL BONE-MESH/PLATE & SCREWS

K952811 is an FDA 510(k) clearance for 3I ORAL/MAXILLOFACIAL BONE FIXATION SYS..., manufactured by Implant Innovations, Inc.. The device is a Class 2 Dental device with product code JEY cleared through the Traditional 510(k) pathway after a 72-day FDA review.

K952811 · Implant Innovations, Inc. · Dental device
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Aug 1995
Decision
72d
Days
Class 2
Risk

K952811 is an FDA 510(k) clearance for the 3I ORAL/MAXILLOFACIAL BONE FIXATION SYSTEM: STAINLESS STEEL BONE-MESH/PLATE &.... Classified as Plate, Bone (product code JEY), Class II - Special Controls.

Submitted by Implant Innovations, Inc. (West Palm Baeach, US). The FDA issued a Cleared decision on August 30, 1995 after a review of 72 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Implant Innovations, Inc. devices

FDA 510(k) Submission Details - K952811

510(k) Number K952811 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 19, 1995
Decision Date August 30, 1995
Days to Decision 72 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
55d faster than avg
Panel avg: 127d · This submission: 72d
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 249
Devices cleared under the same product code (JEY) and FDA review panel - the closest regulatory comparables to K952811.
SYNTHES MANDIBULAR MODULAR FIXATION SYSTEM
K954385 · Synthes (Usa) · Mar 1996
LORENZ 1.0MM, 1.5MM, 2.0MM SYSTEM
K953385 · Walter Lorenz Surgical, Inc. · Sep 1995
9I ORAL/MAXILLOFACIAL BONE FIXATION SYSTEM: BONE MESH-PLATE & SCREWS
K953386 · Implant Innovations, Inc. · Sep 1995
3I ORAL/MAXILLOFACIAL BONE FIXATION SYSTEM: COCRMO ALLOY (VITALIUM) BONE-MESH/PLATE & SCREWS
K952812 · Implant Innovations, Inc. · Aug 1995
MESH TITANIUM IMPLANT SYSTEM
K951687 · Medicon EG · Jul 1995
TITANIUM MANDIBULAT RECONSTRUCTION SYSTEM
K951689 · Medicon EG · Jul 1995