Cleared Traditional

K951392 - MINIBONEPLATE SYSTEM

K951392 is an FDA 510(k) clearance for MINIBONEPLATE SYSTEM, manufactured by Ace Surgical Supply Co., Inc.. The device is a Class 2 Dental device with product code JEY cleared through the Traditional 510(k) pathway after a 45-day FDA review.

K951392 · Ace Surgical Supply Co., Inc. · Dental device
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May 1995
Decision
45d
Days
Class 2
Risk

K951392 is an FDA 510(k) clearance for the MINIBONEPLATE SYSTEM. Classified as Plate, Bone (product code JEY), Class II - Special Controls.

Submitted by Ace Surgical Supply Co., Inc. (Brockton, US). The FDA issued a Cleared decision on May 5, 1995 after a review of 45 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 Ace Surgical Supply Co., Inc. devices

FDA 510(k) Submission Details - K951392

510(k) Number K951392 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 21, 1995
Decision Date May 05, 1995
Days to Decision 45 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
82d faster than avg
Panel avg: 127d · This submission: 45d
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 197
Devices cleared under the same product code (JEY) and FDA review panel - the closest regulatory comparables to K951392.
3I ORAL/MAXILLOFACIAL BONE FIXATION SYSTEM: STAINLESS STEEL BONE-MESH/PLATE & SCREWS
K952811 · Implant Innovations, Inc. · Aug 1995
3I ORAL/MAXILLOFACIAL BONE FIXATION SYSTEM: COCRMO ALLOY (VITALIUM) BONE-MESH/PLATE & SCREWS
K952812 · 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
KLS-MARTIN MICRO OSTEOSYTHESIS SYSTEM(1.5MM)
K944565 · KLS-Martin L.P. · Oct 1994