PERIO CONTROL II

K972642 · Estrad B.V. · EIK · Jan 26, 1998 · Dental

Device Facts

• Record ID: K972642
• Device Name: PERIO CONTROL II
• Applicant: Estrad B.V.
• Product Code: EIK · Dental
• Decision Date: Jan 26, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4565
• Device Class: Class 1
• Attributes: Pediatric

Intended Use

The intended use of the "Perio Control II™" device is to screen patients and to track disease progression in the target population of patients who are suspected of having or already have periodontal disease. Both pediatric and adult patients may be tested.

Device Story

Perio Control II is an electronic periodontal probe used by clinicians during dental examinations. It measures gingival pocket depth by inserting a probe tip into the pocket and forcing a filament into a sleeve until a reference point is reached. The clinician presses a button on the handpiece to trigger the measurement, which is then displayed on an electronics unit. The device also allows manual registration of bleeding on probing and supra-gingival plaque via handpiece buttons. Data can be exported to an external PC or Psion Series 3C computer. The device assists clinicians in quantifying periodontal status, enabling tracking of disease progression over time.

Clinical Evidence

Bench testing and user testing were conducted to compare the Perio Control II against the predicate device. No clinical trials were performed. Testing confirmed that the device meets performance specifications for accuracy (0.2mm) and functionality comparable to the predicate.

Technological Characteristics

Electronic periodontal probe; stainless steel spherical probe tip; measuring range 0-10.5mm; probing force 0.17-0.32 N; probing pressure 100-200 N/cm2; accuracy 0.2mm; sterilization via autoclave; connectivity to external PC or Psion Series 3C.

Indications for Use

Indicated for screening and tracking disease progression in pediatric and adult patients suspected of having or diagnosed with periodontal disease.

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)

Submission Summary (Full Text)

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.<972642

# EXHIBIT 2

JAN 2-6 1998 ESTRAD B.V. Westeinde 46 7711 CL NIEUWLEUSEN The Netherlands Phone [phone] Fax: [phone] Contact name: H. E. Schuldink July 10, 1997

## 510(k) Summary of Safety and Effectiveness per 21 CFR 807.92

- 1. Identification of the Device: Proprietary-Trade Name: "Perio Control IITM" Classification Name: Probe, Periodontal 76EIX. Common/Usual Name: Electronic Periodontal Probe Measuring Device
- Equivalent legally marketed devices This product is similar in design and 2. function to the FLORIDA PROBE. 510(k) Number: K875076

#### 3. Indications for Use (intended use)

The intended use of the "Perio Control II™" device is to screen patients and to track disease progression in the target population of patients who are suspected of having or already have periodontal disease. Both pediatric and adult patients may be tested.

#### Description of the Device: 4.

The Perio Control II™ is used during periodontal examination to measure gingival pocket depth. The pocket depth is displayed on the electronics unit and can be entered in an external computer system, either a PC or a Psion Series 3C)

Also, the eventual occurrence of bleeding on probing can be registered, as well as the presence of supra-gingival plaque. This is judged visually and registered by pressing one of the buttons on the Perio Control IITM handpiece.

The pocket depth is measured by entering the probe tip into the gingival pocket and forcing the filament of the probe up into the sleeve until the sleeve is at a specific reference point. In this position one of the buttons on the Perio Control II handpiece is pressed. The pocket depth is now displayed on the electronics unit.

#### ડ. Safety and Effectiveness, comparison to predicate device.

The results of bench and user testing indicates that the new device is as safe and effective as the predicate device.

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| Characteristic | Predicate device: The<br>Florida probe (K875076) | New device: "Perio<br>Control II ™" |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------|
| Intended Use: | Screen patients and to track<br>disease progression in the target<br>population of patients who are<br>suspected of having or already<br>have periodontal disease. Both<br>pediatric and adult patients may<br>be tested. | Same |
| Physical characteristics: | | |
| Measuring range | 1-10mm | 0-10.5mm |
| Probe tip shape | Rounded edge | spherical |
| Probe tip dimension | 0.4mm | 0.5mm |
| Probe tip material | Titanium | Stainless steel |
| Sterilization | Autoclave | Same |
| Accuracy | 0.2mm | Same |
| Probing force | 0.23-0.27 N | 0.17-0.32 N |
| Probing pressure | 183-215 N/cm2 | 100-200 N/cm2 |

#### Substantial Equivalence Chart 6.

#### 7. Conclusion

After analyzing both bench and user testing data, it is the conclusion of Estrad B.V. that the "Perio Control IITM" is as safe and effective as the predicate device and has no new indications for use, thus rendering it substantially equivalent to the predicate Device.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of flowing lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 2 6 1998

Estrad B.V. ·c/o Daniel Kamm, P.E. Regulatory Engineer Kamm & Associates P.O. Box 7007 Deerfield, Illinois 60015

K972642 Re: Trade Name: Perio Control II Requlatory Class: I Product Code: EIK Dated: October 22, 1997 October 28, 1997 ----Received:

Dear Mr. Kamm:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਰੇ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

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Page 2 - Daniel Kamm, P.E.

This letter will allow you to begin marketing your device as described in your 510 k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at " its internet address "http://www.fda.qov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski
Director

Division of Dental, Infection Control, and Geheral Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### d) Indications for Use

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Device Name: "Perio Control II TM" Periodontal Probing and Measurement Device.

## Indications for Use:

The Perio Control II is used during periodontal examination to measure gingival pocket depth. The pocket depth is displayed on the electronics unit and can be entered in an external computer system, either a PC or a Psion Series 3C.

Also, the eventual occurrence of bleeding on probing can be registered, as well as the presence of supra-gingival plaque. This is judged visually and registered by pressing one of the buttons on the "Perio Control IITM" handpiece.

The pocket depth is measured by entering the probe tip into the gingival pocket and forcing the filament of the probe up into the sleeve is at a specific reference point. In this position one of the buttons on the "Perio Control IITM" handpiece is pressed. The pocket depth is now displayed on the electronics unit.

The intended use of the "Perio Control II™" device is to screen patients and to track disease progression in the target population of patients who are suspected of having or already have periodontal disease. Both pediatric and adult patients may be tested.

# (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

| | <img alt="Signature" src="signature.png"/> |
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| (Division Sign-Off) | |
| Division of Dental, Infection Control, and General Hospital Devices | |
| 510(k) Number | K972642 |

| Prescription Use<br>(Per 21 CFR 801.109) <img alt="Check" src="check.png"/> | OR Over the Counter Use ______ |
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