Cleared Traditional

K972569 - E-TYPE SPEED INCREASER CONTRA ANGLE, EXTERNAL IRRIGATION, INTERNAL IRRIGATION

K972569 is an FDA 510(k) clearance for E-TYPE SPEED INCREASER CONTRA ANGLE, manufactured by Nsk Nakanishi, Inc.. The device is a Class 1 Dental device with product code EGS cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K972569 · Nsk Nakanishi, Inc. · Dental device
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Oct 1997
Decision
90d
Days
Class 1
Risk

K972569 is an FDA 510(k) clearance for the E-TYPE SPEED INCREASER CONTRA ANGLE, EXTERNAL IRRIGATION, INTERNAL IRRIGATION. Classified as Handpiece, Contra- And Right-angle Attachment, Dental (product code EGS), Class I - General Controls.

Submitted by Nsk Nakanishi, Inc. (Tochigi-Ken, JP). The FDA issued a Cleared decision on October 8, 1997 after a review of 90 days - within the typical 510(k) review window.

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: 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 Nsk Nakanishi, Inc. devices

FDA 510(k) Submission Details - K972569

510(k) Number K972569 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 10, 1997
Decision Date October 08, 1997
Days to Decision 90 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
37d faster than avg
Panel avg: 127d · This submission: 90d
Pathway characteristics
Predicate-based equivalence.

EGS Device Classification - Class 1, General Controls

Product Code EGS Handpiece, Contra- And Right-angle Attachment, Dental
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 Peers - EGS Handpiece, Contra- And Right-angle Attachment, Dental

All 43
Devices cleared under the same product code (EGS) and FDA review panel - the closest regulatory comparables to K972569.
EXTENDED STRAIGHT ATTACHMENT
K994024 · Team Technologies, Inc. · Feb 2000
STARDENTAL TITAN 3 LUBEFREE MOTOR ATTACHMENTS
K983574 · Dentalez Group · Jan 1999
23:1 REDUCTION ANGLE
K973800 · Midwest Dental Products Corp. · Mar 1998
SERIES XE, SERIES SE, SERIES TE
K971350 · Micro-Mega Societe Anonyme · Jun 1997
E-TYPE CONTRA ANGLE NAC-E
K962540 · Nsk Nakanishi, Inc. · Sep 1996
SERIES XE 140XE,40XE,10XE/SERIES SE 140SE,40SE,10SE/SERIES 10TE
K961494 · Micro-Mega Societe Anonyme · Jun 1996