Who is the manufacturer of PROSELECT 3 PERIDONTAL THERAPY SYSTEM?

Professional Dental Mfg., Inc. filed the 510(k) submission for PROSELECT 3 PERIDONTAL THERAPY SYSTEM (K964596).

What is the FDA product code for PROSELECT 3 PERIDONTAL THERAPY SYSTEM?

ELC. It is classified under 21 CFR 872.4850 as a Class 2 device in the Dental panel.

What is the regulatory pathway for PROSELECT 3 PERIDONTAL THERAPY SYSTEM?

510(k) clearance (submission type: Traditional).

What are the predicate devices for PROSELECT 3 PERIDONTAL THERAPY SYSTEM?

Dentsply Cavitron® Ultrasonic 3000; Dentsply Cavitron® 1010; Dentsply Cavitron® 660; Johnson & Johnson Alfa-Sonic Hygienic Scaler Model 300; Healthco Air Flow II Scaler.

Who can help prepare an FDA 510(k) submission like PROSELECT 3 PERIDONTAL THERAPY SYSTEM?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

PROSELECT 3 PERIDONTAL THERAPY SYSTEM

K964596 · Professional Dental Mfg., Inc. · ELC · Apr 22, 1997 · Dental

Device Facts

Record ID	K964596
Device Name	PROSELECT 3 PERIDONTAL THERAPY SYSTEM
Applicant	Professional Dental Mfg., Inc.
Product Code	ELC · Dental
Decision Date	Apr 22, 1997
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 872.4850
Device Class	Class 2
Attributes	Therapeutic

Intended Use

The device for which 510(k) recognition of substantial equivalence is sought is an ultrasonic scaler intended for use during dental and periodontal therapy treatments to remove calculus deposits from teeth by application of an ultrasonic vibrating scaler tip to the teeth.

Device Story

Ultrasonic scaler; removes calculus deposits from teeth via vibrating scaler tip. Used in dental/periodontal therapy. Operated by dental professionals in clinical settings. Device applies ultrasonic energy to tip to mechanically dislodge calculus. Output is mechanical vibration; aids clinician in cleaning procedures; improves periodontal health.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Ultrasonic scaler; utilizes ultrasonic vibration for calculus removal. Form factor: dental handpiece with interchangeable tips. Energy source: electrical power converted to ultrasonic mechanical energy. No software or digital connectivity.

Indications for Use

Indicated for dental and periodontal therapy to remove calculus deposits from teeth in patients requiring professional dental cleaning.

Regulatory Classification

Identification

An ultrasonic scaler is a device intended for use during dental cleaning and periodontal (gum) therapy to remove calculus deposits from teeth by application of an ultrasonic vibrating scaler tip to the teeth.

Predicate Devices

Dentsply Cavitron® Ultrasonic 3000
Dentsply Cavitron® 1010
Dentsply Cavitron® 660
Johnson & Johnson Alfa-Sonic Hygienic Scaler Model 300
Healthco Air Flow II Scaler

Related Devices

K983727 — BIOSONIC ULTRASONIC SCALER SYSTEM · Coltene/Whaledent, Inc. · Jan 20, 1999
K051910 — MAXISONIC FAMILY AND SWIFT ULTRASONIC SCALER · D.B.I. America Corp. · Sep 2, 2005
K062791 — USI DENTAL SCALER, 25XXX SERIES · Ultrasonic Services, Inc. · Dec 11, 2006
K061448 — BONART ART-P3II & P4 PIEZO ELECTRIC ULTRASONIC SCALER UNITS WITH ACCESSORIES · Bonart Co., Ltd. · Aug 17, 2006
K051547 — POWERMAX 25, MODEL PM25; POWERMAX 30, MODEL PM30 · Tpc Advanced Technology, Inc. · Jul 14, 2005

Submission Summary (Full Text)

{0} K 964590 # C. EXECUTIVE SUMMARY APR 22 1997 ## 1. Reason for Submission Premarket notification, as required under Section 510(k) of the Federal Food, Drug, and Cosmetic (FD&C) Act, facilitates the marketing of medical devices that are "new" to a company but substantially equivalent to devices that are already legally marketed. This submission provides the premarket notification required by section 510(k) of the Act and 21 CFR §807.87. ## 2. Description The device for which 510(k) recognition of substantial equivalence is sought is an ultrasonic scaler intended for use during dental and periodontal therapy treatments to remove calculus deposits from teeth by application of an ultrasonic vibrating scaler tip to the teeth. ## 3. Substantial Equivalence Comparison in terms of "substantial equivalence" is made to other marketed devices. Professional Dental Manufacturing, Inc.'s device is substantially equivalent to predicate devices because it has the same intended use as a host of ultrasonic scalers, in particular, Dentsply's Cavitron® Ultrasonic 3000, 1010 and 660 Scalers, Johnson & Johnson's Alfa-Sonic Hygienic Scaler Model 300 and Healthco's Air Flow II Scaler. For purposes of this PMN, we will compare the Pro-Select3™ to the Cavitron® Model 3000. This PMN establishes that the Pro-Select3™ is substantially equivalent to the predicate device in its respective ability to remove calculus deposits from the teeth. Furthermore, this PMN establishes that Pro-Select3™'s technological characteristics are similar enough to the Cavitron® devices that it will not affect safety and effectiveness.