Cleared Traditional

K952812 - 3I ORAL/MAXILLOFACIAL BONE FIXATION SYS...

K952812 is the FDA 510(k) clearance for 3I ORAL/MAXILLOFACIAL BONE FIXATION SYS... by Implant Innovations, Inc.. It is a Class 2 Dental device (product code JEY) cleared through the Traditional 510(k) pathway after a 72-day FDA review.

K952812 · Implant Innovations, Inc. · Dental device
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Aug 1995
Decision
72d
Days
Class 2
Risk

K952812 is an FDA 510(k) clearance for the 3I ORAL/MAXILLOFACIAL BONE FIXATION SYSTEM: COCRMO ALLOY (VITALIUM) BONE-MESH.... 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

Submission Details

510(k) Number K952812 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.

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 156
Devices cleared under the same product code (JEY) and FDA review panel - the closest regulatory comparables to K952812.
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: STAINLESS STEEL BONE-MESH/PLATE & SCREWS
K952811 · Implant Innovations, Inc. · Aug 1995
LUHR MANDIBULAR/SMALL FIXATION IMPLANTS
K950595 · Howmedica Corp. · Jul 1995
MAN SURG INSTR/ACCESS TO KLS-MARTIN MICRO OSTEO SYST
K944560 · KLS-Martin L.P. · Oct 1994
MICRO OSTEOSYNTHESIS SYSTEM (1.0)
K944561 · KLS-Martin L.P. · Oct 1994