Cleared Traditional

K000837 - PUMA DENTAL CHAIR AND UNIT

K000837 is an FDA 510(k) clearance for PUMA DENTAL CHAIR AND UNIT, manufactured by Castellini S.P.A.. The device is a Class 1 Dental device with product code EIA cleared through the Traditional 510(k) pathway after a 120-day FDA review.

K000837 · Castellini S.P.A. · Dental device
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Jul 2000
Decision
120d
Days
Class 1
Risk

K000837 is an FDA 510(k) clearance for the PUMA DENTAL CHAIR AND UNIT. Classified as Unit, Operative Dental (product code EIA), Class I - General Controls.

Submitted by Castellini S.P.A. (Castel Maggiore, Bologna, IT). The FDA issued a Cleared decision on July 11, 2000 after a review of 120 days - within the typical 510(k) review window.

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 - K000837

510(k) Number K000837 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 13, 2000
Decision Date July 11, 2000
Days to Decision 120 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
8d faster than avg
Panel avg: 128d · This submission: 120d
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 282
Devices cleared under the same product code (EIA) and FDA review panel - the closest regulatory comparables to K000837.
WATER PURIFIER
K001878 · Waterclave, LLC · Aug 2000
SMILIE PC
K001445 · Julie Alliance · Jul 2000
MINICAM
K001541 · Video Dental Concepts, Inc. · Jul 2000
BELMONT UNIT, MODEL 2000 SERIES
K000799 · Belmont Equipment Corp. · May 2000
YOSHIDA WAVE PICT CAM INTRAORAL CAMERA, SIGMA BIOMEDICS SIGMACAM INTRAORAL CAMERA
K000577 · The Yoshida Dental Mfg. Co., Ltd. · May 2000
4631 DUO DELIVERY SYSTEM
K000966 · A-Dec, Inc. · May 2000
K000837 · PUMA DENTAL CHAIR AND UNIT
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