Cleared Traditional

K884308 - MANDIBLE MANIPULATOR

K884308 is an FDA 510(k) clearance for MANDIBLE MANIPULATOR, manufactured by Leonard Medical, Inc.. The device is a Class 1 Dental device with product code EKJ cleared through the Traditional 510(k) pathway after a 169-day FDA review.

K884308 · Leonard Medical, Inc. · Dental device
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Mar 1989
Decision
169d
Days
Class 1
Risk

K884308 is an FDA 510(k) clearance for the MANDIBLE MANIPULATOR. Classified as Burnisher, Operative (product code EKJ), Class I - General Controls.

Submitted by Leonard Medical, Inc. (Huntingdon Valley, US). The FDA issued a Cleared decision on March 31, 1989 after a review of 169 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4565 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Leonard Medical, Inc. devices

FDA 510(k) Submission Details - K884308

510(k) Number K884308 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 13, 1988
Decision Date March 31, 1989
Days to Decision 169 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
42d slower than avg
Panel avg: 127d · This submission: 169d
Pathway characteristics
Predicate-based equivalence.

EKJ Device Classification - Class 1, General Controls

Product Code EKJ Burnisher, Operative
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.4565
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - EKJ Burnisher, Operative

All 23
Devices cleared under the same product code (EKJ) and FDA review panel - the closest regulatory comparables to K884308.
MIRROR SHIELD
K901053 · Pulpdent Corp. · May 1990
RUBBER DAM CLAMPS/FORCEPS
K892261 · Zinnanti Surgical Instruments, Inc. · May 1989
PRICHARD PERIOSTEAL RETRACTOR #3
K892260 · Zinnanti Surgical Instruments, Inc. · May 1989
DENTAL SYRINGE APPLICATION TIP
K890064 · Centrix, Inc. · Feb 1989
RACESTYPTINE
K884653 · Specialites Septodont · Jan 1989
BENDA BRUSH
K885162 · Centrix, Inc. · Jan 1989