Cleared Traditional

K892239 - DENTAL HAND INSTRUMENTS

K892239 is an FDA 510(k) clearance for DENTAL HAND INSTRUMENTS, manufactured by Implant Support Systems, Inc.. The device is a Class 1 Dental device with product code EKJ cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K892239 · Implant Support Systems, Inc. · Dental device
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May 1989
Decision
84d
Days
Class 1
Risk

K892239 is an FDA 510(k) clearance for the DENTAL HAND INSTRUMENTS. Classified as Burnisher, Operative (product code EKJ), Class I - General Controls.

Submitted by Implant Support Systems, Inc. (Irvine, US). The FDA issued a Cleared decision on May 18, 1989 after a review of 84 days - a notably fast clearance 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: 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 Implant Support Systems, Inc. devices

FDA 510(k) Submission Details - K892239

510(k) Number K892239 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 23, 1989
Decision Date May 18, 1989
Days to Decision 84 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
43d faster than avg
Panel avg: 127d · This submission: 84d
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 K892239.
HARDCOATED PLASTIC FILLING INSTRUMENT
K912149 · Premier Dental Products Co. · Jun 1991
PULPDENT PIC N STIC
K911281 · Pulpdent Corp. · May 1991
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