Cleared Traditional

K993188 - ENDOSTEPPER 1

K993188 is an FDA 510(k) clearance for ENDOSTEPPER 1, manufactured by Phytron- Elektronik GmbH. The device is a Class 1 Dental device with product code EKX cleared through the Traditional 510(k) pathway after a 5-day FDA review.

K993188 · Phytron- Elektronik GmbH · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1999
Decision
5d
Days
Class 1
Risk

K993188 is an FDA 510(k) clearance for the ENDOSTEPPER 1. Classified as Handpiece, Direct Drive, Ac-powered (product code EKX), Class I - General Controls.

Submitted by Phytron- Elektronik GmbH (Grobenzell, DE). The FDA issued a Cleared decision on September 28, 1999 after a review of 5 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4200 - 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 Phytron- Elektronik GmbH devices

FDA 510(k) Submission Details - K993188

510(k) Number K993188 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 23, 1999
Decision Date September 28, 1999
Days to Decision 5 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
122d faster than avg
Panel avg: 127d · This submission: 5d
Pathway characteristics
Predicate-based equivalence. Third-party reviewed.

EKX Device Classification - Class 1, General Controls

Product Code EKX Handpiece, Direct Drive, Ac-powered
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.4200
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 Consultant

Tuv Product Service, Inc.
CAROLE STAMP

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - EKX Handpiece, Direct Drive, Ac-powered

All 59
Devices cleared under the same product code (EKX) and FDA review panel - the closest regulatory comparables to K993188.
IMPLANT HANDPIECES
K051661 · Sirona Dental Systems GmbH · Sep 2005
DENTAPORT ZX
K031204 · J. Morita USA, Inc. · Aug 2003
ASEPTICO VCT VERSATILE COMMAND TECHNOLOGY MODEL AEU-925
K030163 · Aseptico, Inc. · Mar 2003
QUANTEC-E ENDO SYSTEM
K990739 · Sybron Dental Specialties, Inc. · May 1999
PROPHY-MATE MOTOR HANDPIECE, MODELS PROPHY-MATE (2000 RPM MAX), ENDO-MATE (600RPM MAX.)
K990682 · Nsk Nakanishi, Inc. · Mar 1999
PORTABLE ELECTRIC MOTOR-HANDPIECE UNIT, HANDY-MATE
K990646 · Nsk Nakanishi, Inc. · Mar 1999