Cleared Traditional

K993862 - MODUS SAGITTAL SPLIT PLATE

K993862 is an FDA 510(k) clearance for MODUS SAGITTAL SPLIT PLATE, manufactured by The Straumann Co.. The device is a Class 2 Dental device with product code JEY cleared through the Traditional 510(k) pathway after a 44-day FDA review.

K993862 · The Straumann Co. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1999
Decision
44d
Days
Class 2
Risk

K993862 is an FDA 510(k) clearance for the MODUS SAGITTAL SPLIT PLATE. Classified as Plate, Bone (product code JEY), Class II - Special Controls.

Submitted by The Straumann Co. (Waltham, US). The FDA issued a Cleared decision on December 29, 1999 after a review of 44 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 The Straumann Co. devices

FDA 510(k) Submission Details - K993862

510(k) Number K993862 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 15, 1999
Decision Date December 29, 1999
Days to Decision 44 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
83d faster than avg
Panel avg: 127d · This submission: 44d
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 237
Devices cleared under the same product code (JEY) and FDA review panel - the closest regulatory comparables to K993862.
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THE BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY
K992330 · Biomedics · Nov 1999