VIP VICTOR INTERACTIVE PROBE

K960245 · Pro-Dentec · EIX · Apr 4, 1996 · Dental

Device Facts

• Record ID: K960245
• Device Name: VIP VICTOR INTERACTIVE PROBE
• Applicant: Pro-Dentec
• Product Code: EIX · Dental
• Decision Date: Apr 4, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4565
• Device Class: Class 1

Intended Use

Pro-Dentec’s VICTOR Interactive Probe is an automated periodontal probe intended for use during periodontal examinations to measure and chart the depth of a gingival sulcus in millimeters.

Device Story

Electronic periodontal probe; used by dental professionals during periodontal exams. System comprises control unit, transducer with cable, and single-use disposable handpieces. Device measures and charts gingival sulcus depth in millimeters. Automates traditional manual probing process; provides digital output for clinical charting. Benefits include standardized, automated measurement of periodontal pocket depth, assisting clinicians in periodontal assessment and decision-making.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and intended use comparison to predicate devices.

Technological Characteristics

Electronic periodontal probe; consists of control unit, transducer, and disposable handpieces. Automated measurement system. Connectivity via cable between transducer and control unit.

Indications for Use

Indicated for dental professionals performing periodontal examinations to measure and chart gingival sulcus depth in millimeters.

Regulatory Classification

Identification

A dental hand instrument is a hand-held device intended to perform various tasks in general dentistry and oral surgery procedures. The device includes the operative burnisher, operative amalgam carrier, operative dental amalgam carver, surgical bone chisel, operative amalgam and foil condenser, endodontic curette, operative curette, periodontic curette, surgical curette, dental surgical elevator, operative dental excavator, operative explorer surgical bone file, operative margin finishing file, periodontic file, periodontic probe, surgical rongeur forceps, surgical tooth extractor forceps, surgical hemostat, periodontic hoe, operative matrix contouring instrument, operative cutting instrument, operative margin finishing periodontic knife, periodontic marker, operative pliers, endodontic root canal plugger, endodontic root canal preparer, surgical biopsy punch, endodontic pulp canal reamer, crown remover, periodontic scaler, collar and crown scissors, endodontic pulp canal filling material spreader, surgical osteotome chisel, endodontic broach, dental wax carver, endodontic pulp canal file, hand instrument for calculus removal, dental depth gauge instrument, plastic dental filling instrument, dental instrument handle, surgical tissue scissors, mouth mirror, orthodontic band driver, orthodontic band pusher, orthodontic band setter, orthodontic bracket aligner, orthodontic pliers, orthodontic ligature tucking instrument, forceps, for articulation paper, forceps for dental dressing, dental matrix band, matrix retainer, dental retractor, dental retractor accessories, periodontic or endodontic irrigating syringe, and restorative or impression material syringe.

Predicate Devices

• Florida Probe (K875076)
• Manual Michigan periodontal probes

Submission Summary (Full Text)

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K960245

# I. 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

## 1. Name and Address

This Summary of Safety and Effectiveness is being submitted by Pro-Dentec, Inc., P.O. Box 4129, Batesville, Arkansas 72503. The telephone number is 501-793-2300.

## 2. Name of the Device

The device is generally known as an Electronic Periodontal Probe.

## 3. Identification of Predicate Device(s)

Florida Probe Corporation’s "Florida Probe," K875076, and the manual Michigan periodontal probes.

## 4. Description of the Device

The device is a periodontal probe which is used by dental professionals during periodontal examinations. The device consists of a control unit, a transducer connected by a cable to the control unit and single use, disposable handpieces.

## 5. Intended Use of the Device

Pro-Dentec’s VICTOR Interactive Probe is an automated periodontal probe intended for use during periodontal examinations to measure and chart the depth of a gingival sulcus in millimeters.

## 6. Comparison of Technological Characteristics

The differences between Pro-Dentec’s VICTOR Interactive Probe and the predicate device are minor and do not impact the safety and effectiveness of the device in any significant way.

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