Cleared Traditional

K933582 - PROFILE SERIES 29 FILES

K933582 is an FDA 510(k) clearance for PROFILE SERIES 29 FILES, manufactured by Tulsa Dental Products, Ltd.. The device is a Class 1 Dental device with product code EKS cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K933582 · Tulsa Dental Products, Ltd. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1993
Decision
89d
Days
Class 1
Risk

K933582 is an FDA 510(k) clearance for the PROFILE SERIES 29 FILES. Classified as File, Pulp Canal, Endodontic (product code EKS), Class I - General Controls.

Submitted by Tulsa Dental Products, Ltd. (Tulsa, US). The FDA issued a Cleared decision on October 20, 1993 after a review of 89 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.

FDA 510(k) Submission Details - K933582

510(k) Number K933582 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 23, 1993
Decision Date October 20, 1993
Days to Decision 89 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
39d faster than avg
Panel avg: 128d · This submission: 89d
Pathway characteristics
Predicate-based equivalence.

EKS Device Classification - Class 1, General Controls

Product Code EKS File, Pulp Canal, Endodontic
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 - EKS File, Pulp Canal, Endodontic

All 16
Devices cleared under the same product code (EKS) and FDA review panel - the closest regulatory comparables to K933582.
SHAPING HEDSTROM N.T.
K953604 · Sybron Dental Specialties, Inc. · Sep 1995
NICKEL-TITANIUM K-TYPE FILE
K935542 · Union Broach, Div. Moyco Industries, Inc. · Jan 1994
LIGHTSPEED DENTAL HAND INSTRUMENT
K932529 · Lightspeed Endodontics · Nov 1993
DENTAURUM CERAMIC DEBONDING UNIT
K902018 · Dentauraum, Inc. · Apr 1991
PROCEDURE KIT/ROUTINE DENTAL PROCEDURES
K905461 · Angiosystems, Inc. · Mar 1991
SOLID CORE GUTTA PERCHA CARRIER
K905640 · The Hygenic Corp. · Mar 1991
K933582 · PROFILE SERIES 29 FILES
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