Cleared Traditional

K081811 - CARE3 PLUS

K081811 is the FDA 510(k) clearance for CARE3 PLUS by Nakanishi, Inc.. It is a Class 1 Dental device (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

Submission Details

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.

Device Classification

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 77
Devices cleared under the same product code (EFB) and FDA review panel - the closest regulatory comparables to K081811.
BOSWORTH AIR POLISHER
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CENTURY MODEL 105C
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K091065 · J. Morita USA, Inc. · Oct 2009
A-DEC/W&H ALEGRA AIR-DRIVEN HIGHSPEED HANDPIECE, MODEL TE-97, TE-98, A-DEC/W&H ALEGRA HANDPIECE ATTACHMENT, MODEL HE-43
K082716 · A-Dec, Inc. · Jan 2009
A-DEC/W&H PROFIN RECIPROCATING CONTRA-ANGLE HANDPIECE ATTACHMENT
K082827 · A-Dec, Inc. · Jan 2009
SUPERTORQUE HIGH-SPEED HANDPIECES AND GENTLEPOWER HANDPIECES AND ATTACHEMENTS
K073478 · Sybron Dental Specialties, Inc. · Sep 2008