Cleared Traditional

K951016 - DISPOSABLE PROPHYLAXIS ANGLE

K951016 is an FDA 510(k) clearance for DISPOSABLE PROPHYLAXIS ANGLE, manufactured by Preventive Technologies, Inc.. The device is a Class 1 Dental device with product code EHK cleared through the Traditional 510(k) pathway after a 57-day FDA review.

K951016 · Preventive Technologies, Inc. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 1995
Decision
57d
Days
Class 1
Risk

K951016 is an FDA 510(k) clearance for the DISPOSABLE PROPHYLAXIS ANGLE. Classified as Cup, Prophylaxis (product code EHK), Class I - General Controls.

Submitted by Preventive Technologies, Inc. (Charlotte, US). The FDA issued a Cleared decision on May 2, 1995 after a review of 57 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6290 - 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.

FDA 510(k) Submission Details - K951016

510(k) Number K951016 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 06, 1995
Decision Date May 02, 1995
Days to Decision 57 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
71d faster than avg
Panel avg: 128d · This submission: 57d
Pathway characteristics
Predicate-based equivalence.

EHK Device Classification - Class 1, General Controls

Product Code EHK Cup, Prophylaxis
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.6290
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 - EHK Cup, Prophylaxis

All 7
Devices cleared under the same product code (EHK) and FDA review panel - the closest regulatory comparables to K951016.
PROPHY ANGLE
K953628 · Rolence Enterprise Co. , Ltd. · Sep 1995
DISPOSABLE SCREW TYPE PROPHY BRUSH
K900507 · Dentsply Intl. · Apr 1990
DENTAL PROPHY CUPS (VARIOUS TYPES)
K864059 · Mission White Dental, Inc. · Nov 1986
PROPHYLAXIS CUP.
K803155 · Teledyne Densco · Jan 1981
PROPHYLAXIS CUPS AND POLISHERS
K790723 · Young Dental Manufacturing Co. 1, LLC · Jun 1979
PROPHY CUPS, R&R
K780198 · Ransom and Randolph · Feb 1978
K951016 · DISPOSABLE PROPHYLAXIS ANGLE
Download PDF FDA Summary Preventive Technologi…