Cleared Traditional

K882526 - DELIVERY PUMP FOR STERILE IRRIGANT & HANDPIECE DR.

K882526 is an FDA 510(k) clearance for DELIVERY PUMP FOR STERILE IRRIGANT & HA..., manufactured by Aseptico, Inc.. The device is a Class 1 Dental device with product code EIA cleared through the Traditional 510(k) pathway after a 191-day FDA review.

K882526 · Aseptico, Inc. · Dental device
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Dec 1988
Decision
191d
Days
Class 1
Risk

K882526 is an FDA 510(k) clearance for the DELIVERY PUMP FOR STERILE IRRIGANT & HANDPIECE DR.. Classified as Unit, Operative Dental (product code EIA), Class I - General Controls.

Submitted by Aseptico, Inc. (Kirkland, US). The FDA issued a Cleared decision on December 8, 1988 after a review of 191 days - an extended review 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: 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.

FDA 510(k) Submission Details - K882526

510(k) Number K882526 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 31, 1988
Decision Date December 08, 1988
Days to Decision 191 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
63d slower than avg
Panel avg: 128d · This submission: 191d
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 268
Devices cleared under the same product code (EIA) and FDA review panel - the closest regulatory comparables to K882526.
QUICK-TIP (DENTAL OPERATORY UNIT)
K891006 · Bernard S Esrock · May 1989
BRACKET TABLE ARM COVER
K884219 · Steri-Shield Products, Inc. · Mar 1989
SANI-SLEEVE DRAPE FOR DENTAL USE
K885299 · Nieusma R & D, Inc. · Mar 1989
APOLLO VS, VT, VR 1000/1500, FREEDOM HS, HT, HR
K883904 · Apollo Dental Products, Inc. · Dec 1988
PORTABLE II DENTAL DELIVERY SYSTEM
K883775 · Dntl Corp. · Oct 1988
EASY-OP, PORTABLE DENTAL CART
K882810 · Wy'East Medical Corp. · Aug 1988
K882526 · DELIVERY PUMP FOR STERILE IRRIGANT & HANDPIECE DR.
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