Cleared Traditional

TMP MANDIBULAR COMPRESSION SYSTEM (MODIFICATION) (K960514) - FDA 510(k) Clearance

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

K960514 · Anspach Fixation Systems · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1996
Decision
81d
Days
Class 2
Risk

K960514 is an FDA 510(k) clearance for the TMP MANDIBULAR COMPRESSION SYSTEM (MODIFICATION). Classified as Plate, Bone (product code JEY), Class II - Special Controls.

Submitted by Anspach Fixation Systems (Palm Beach Gardens, US). The FDA issued a Cleared decision on April 15, 1996 after a review of 81 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 Anspach Fixation Systems devices

Submission Details

510(k) Number K960514 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 25, 1996
Decision Date April 15, 1996
Days to Decision 81 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
46d faster than avg
Panel avg: 127d · This submission: 81d
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 93
Devices cleared under the same product code (JEY) and FDA review panel - the closest regulatory comparables to K960514.
SYNTHES (USA) [SYNTHES] MINI EXTERNAL FIXATOR
K971987 · Synthes (Usa) · Jun 1997
SYNTHES (USA) SYNTHES MMFS-ADJUSTABLE SAGITTAL SPLIT PLATE
K964328 · Synthes (Usa) · Dec 1996
SYNTHES 2.4 MM UNIVERSAL LOCKING PLATE SYSTEM
K961421 · Synthes (Usa) · Jun 1996
SYNTHES (USA) MIDFACIAL SYSTEM
K953806 · Synthes (Usa) · Mar 1996
SYNTHES MANDIBULAR MODULAR FIXATION SYSTEM
K954385 · Synthes (Usa) · Mar 1996
LUHR MANDIBULAR/SMALL FIXATION IMPLANTS
K950595 · Howmedica Corp. · Jul 1995