Cleared Traditional

K881253 - ROTORY SCALER SWIVEL IMPROVEMENT FEATURE, TITAN SW

K881253 is an FDA 510(k) clearance for ROTORY SCALER SWIVEL IMPROVEMENT FEATURE, manufactured by Dentalez Group. The device is a Class 2 Dental device with product code ELC cleared through the Traditional 510(k) pathway after a 29-day FDA review.

K881253 · Dentalez Group · Dental device
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Apr 1988
Decision
29d
Days
Class 2
Risk

K881253 is an FDA 510(k) clearance for the ROTORY SCALER SWIVEL IMPROVEMENT FEATURE, TITAN SW. Classified as Scaler, Ultrasonic (product code ELC), Class II - Special Controls.

Submitted by Dentalez Group (Lancaster, US). The FDA issued a Cleared decision on April 21, 1988 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4850 - 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 - K881253

510(k) Number K881253 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 23, 1988
Decision Date April 21, 1988
Days to Decision 29 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
99d faster than avg
Panel avg: 128d · This submission: 29d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ELC Device Classification - Class 2, Special Controls

Product Code ELC Scaler, Ultrasonic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.4850
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Peers - ELC Scaler, Ultrasonic

All 169
Devices cleared under the same product code (ELC) and FDA review panel - the closest regulatory comparables to K881253.
LYNX-SM, SCLAER DENTAL HANDPIECE
K901488 · Mti Precision Products · May 1990
AIR FLOW SII
K900709 · Electro Medical Systems (Ems Sa) · Apr 1990
PERIODONTAL IRRIGATING SOLUTION-D
K894247 · Dentsply Intl. · Oct 1989
ULTRASONIC SCALER 3000/ PROPHY-JET 30/ CAVI-JET 30
K864996 · Dentsply Intl. · Feb 1987
GENTEEL
K863676 · Luben Dental Co., Inc. · Oct 1986
HARMO SONIC
K853841 · U.S. Shizai Corp. · Feb 1986
K881253 · ROTORY SCALER SWIVEL IMPROVEMENT FEATURE, TITAN SW
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