Cleared Traditional

K081811 - CARE3 PLUS

K081811 is an FDA 510(k) clearance for CARE3 PLUS, manufactured by Nakanishi, Inc.. The device is a Class 1 Dental device with product code EFB cleared through the Traditional 510(k) pathway after a 209-day FDA review.

K081811 · Nakanishi, Inc. · Dental device
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Jan 2009
Decision
209d
Days
Class 1
Risk

K081811 is an FDA 510(k) clearance for the CARE3 PLUS. Classified as Handpiece, Air-powered, Dental (product code EFB), Class I - General Controls.

Submitted by Nakanishi, Inc. (Washington, US). The FDA issued a Cleared decision on January 21, 2009 after a review of 209 days - an extended review 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: 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 Nakanishi, Inc. devices

FDA 510(k) Submission Details - K081811

510(k) Number K081811 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 26, 2008
Decision Date January 21, 2009
Days to Decision 209 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
82d slower than avg
Panel avg: 127d · This submission: 209d
Pathway characteristics
Predicate-based equivalence.

EFB Device Classification - Class 1, General Controls

Product Code EFB Handpiece, Air-powered, 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 - EFB Handpiece, Air-powered, Dental

All 161
Devices cleared under the same product code (EFB) and FDA review panel - the closest regulatory comparables to K081811.
AIR TORX, MODEL TRA-200, TRA-200-CP3, TRA-200-CP4
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