Cleared Traditional

K812909 - HYGIENTIST

Also marketed or referenced as:
CYCLOSON I & II RETROFIT

K812909 is an FDA 510(k) clearance for HYGIENTIST, manufactured by Fibra Sonics, Inc.. The device is a Class 2 Dental device with product code ELC cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K812909 · Fibra Sonics, Inc. · Dental device
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Dec 1981
Decision
56d
Days
Class 2
Risk

K812909 is an FDA 510(k) clearance for the HYGIENTIST. Classified as Scaler, Ultrasonic (product code ELC), Class II - Special Controls.

Submitted by Fibra Sonics, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 14, 1981 after a review of 56 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.

View all Fibra Sonics, Inc. devices

FDA 510(k) Submission Details - K812909

510(k) Number K812909 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 19, 1981
Decision Date December 14, 1981
Days to Decision 56 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
71d faster than avg
Panel avg: 127d · This submission: 56d
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 66
Devices cleared under the same product code (ELC) and FDA review panel - the closest regulatory comparables to K812909.
ULTRASONIC TOOTH SCALER MODEL DSCIOP
K852540 · Parkell, Inc. · Jul 1985
CAVI-MED
K842581 · Cooper Lasersonics, Inc. · Aug 1984
DENTAL ULTRASONIC SCALER/ENDOSONIC
K840141 · CooperVision, Inc. · Mar 1984
ROOT CANAL KIT
K811023 · Dentsply Intl. · May 1981
MODEL G-61 ULTRASONIC DENTAL UNIT
K791585 · Cavitron Corp. · Sep 1979
ULTRASONIC DENTAL PROPHYLAXIS DEVICE
K760805 · Cavitron Corp. · Oct 1976