Cleared Traditional

K012720 - TULSA CONTRA ANGLES

K012720 is the FDA 510(k) clearance for TULSA CONTRA ANGLES by Dentsply Intl.. It is a Class 1 Dental device (product code EFB) cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K012720 · Dentsply Intl. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2001
Decision
85d
Days
Class 1
Risk

K012720 is an FDA 510(k) clearance for the TULSA CONTRA ANGLES. Classified as Handpiece, Air-powered, Dental (product code EFB), Class I - General Controls.

Submitted by Dentsply Intl. (York, US). The FDA issued a Cleared decision on November 8, 2001 after a review of 85 days - a notably fast clearance 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: 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 Dentsply Intl. devices

Submission Details

510(k) Number K012720 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 15, 2001
Decision Date November 08, 2001
Days to Decision 85 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
42d faster than avg
Panel avg: 127d · This submission: 85d
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 78
Devices cleared under the same product code (EFB) and FDA review panel - the closest regulatory comparables to K012720.
SIROAIR L AIR SCALER
K033812 · Sirona Dental Systems GmbH · Feb 2004
PROPHY-MATE
K032395 · Nakanishi, Inc. · Oct 2003
ESTYLUS ELECTRIC MOTOR SYSTEM
K031145 · Dentsply Intl. · Jul 2003
W & H ASSISTINA
K010127 · A-Dec, Inc. · Oct 2001
RAPIDD HIGHSPEED DENTAL HANDPIECE
K003518 · Dentsply Intl. · Jan 2001
SYNEA - LS LOW-SPEED HANDPIECE
K993526 · A-Dec, Inc. · Jan 2000