Cleared Traditional

K971278 - PURE COMPANY FLUID DELIVERY SYSTEM

K971278 is an FDA 510(k) clearance for PURE COMPANY FLUID DELIVERY SYSTEM, manufactured by Pure Co.. The device is a Class 1 Dental device with product code EIA cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K971278 · Pure Co. · Dental device
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Jul 1997
Decision
87d
Days
Class 1
Risk

K971278 is an FDA 510(k) clearance for the PURE COMPANY FLUID DELIVERY SYSTEM. Classified as Unit, Operative Dental (product code EIA), Class I - General Controls.

Submitted by Pure Co. (Santa Maria, US). The FDA issued a Cleared decision on July 3, 1997 after a review of 87 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6640 - 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 Pure Co. devices

FDA 510(k) Submission Details - K971278

510(k) Number K971278 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 07, 1997
Decision Date July 03, 1997
Days to Decision 87 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
40d faster than avg
Panel avg: 127d · This submission: 87d
Pathway characteristics
Predicate-based equivalence.

EIA Device Classification - Class 1, General Controls

Product Code EIA Unit, Operative Dental
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.6640
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 - EIA Unit, Operative Dental

All 109
Devices cleared under the same product code (EIA) and FDA review panel - the closest regulatory comparables to K971278.
DENTALVIEW PERIOVIEW SYSTEM
K973492 · Dentalview, Inc. · Oct 1997
VIOLA II DENTAL CAMERA SYSTEM
K973035 · Innovative Medical Systems, Inc. · Sep 1997
DCI WATER PURIFIER
K971727 · Dental Components, Inc. · Sep 1997
PEFECT SHOT
K972019 · International Imaging Electronics · Jul 1997
PLANMECA INTRACAM
K972033 · Planmeca Oy · Jun 1997
INFECTION CONTROL CARTRIDGE
K964942 · Dentalpure Corp. · Jun 1997