Cleared Traditional

MODUS SAGITTAL SPLIT PLATE (K993862) - FDA 510(k) Clearance

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

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

Submission Details

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
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.

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 90
Devices cleared under the same product code (JEY) and FDA review panel - the closest regulatory comparables to K993862.
SMF RESORBABLE MESHES AND SHEETS
K003786 · Synthes (Usa) · Feb 2001
MAXILLARY DISTRACTOR
K003393 · Synthes (Usa) · Jan 2001
SYNTHES (USA) RESORBABLE TACK SYSTEM
K000560 · Synthes (Usa) · Jan 2001
LACTOSORB SHEETS
K992158 · Biomet, Inc. · Aug 1999
MICRO DYNAMIC MESH
K983528 · Howmedica Corp. · Dec 1998
SYNTHES (USA) [SYNTHES] MMFS - 2.0 MM SAGITTAL SPLIT PLATES
K981890 · Synthes (Usa) · Aug 1998