PIEZOSURGERY 3; OSSTEM PIEZO

K091227 · Piezosurgery S.R.L. · DZI · Dec 29, 2009 · Dental

Device Facts

• Record ID: K091227
• Device Name: PIEZOSURGERY 3; OSSTEM PIEZO
• Applicant: Piezosurgery S.R.L.
• Product Code: DZI · Dental
• Decision Date: Dec 29, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4120
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The OSSTEMPiezo is intended for use in the following dental applications: - Bone cutting for use in oral surgery - Removing supra and subgingival calculus deposits and stains from teeth - Periodontal pocket lavage with simultaneous ultrasonic tip movement - Scaling and root planing - Retrograde preparation of root canals

Device Story

OSSTEMPiezo uses piezoelectric ultrasonic technology to generate mechanical microvibrations in insert tips. Device performs bone cutting and ultrasonic scaling in dental settings. Operated by dental professionals. Microvibrations allow precise cutting of mineralized structures while minimizing trauma to adjacent soft tissue; reduces tissue heating; improves surgical tactile control. Benefits include improved post-operative healing and safer osteotomies. Device includes blunt and smoothing tips for various surgical applications.

Clinical Evidence

Bench testing only. Evaluations demonstrated that piezoelectric ultrasonic microvibrations enable effective cutting of mineralized structures with minimal soft tissue trauma, reduced tissue heating, and improved surgical control compared to traditional methods.

Technological Characteristics

Piezoelectric ultrasonic generator; mechanical microvibration principle; insert tips for bone cutting and scaling; dental handpiece form factor; Class II device.

Indications for Use

Indicated for dental patients requiring oral surgery (bone cutting), periodontal treatment (scaling, root planing, pocket lavage), or endodontic surgery (retrograde root canal preparation).

Regulatory Classification

Identification

A bone cutting instrument and accessories is a metal device intended for use in reconstructive oral surgery to drill or cut into the upper or lower jaw and may be used to prepare bone to insert a wire, pin, or screw. The device includes the manual bone drill and wire driver, powered bone drill, rotary bone cutting handpiece, and AC-powered bone saw.

Predicate Devices

• Piezosurgery® device (K052518)

Submission Summary (Full Text)

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**PIEZOSURGERY**®

K091227

162

Piezosurgery s.r.l. Registered Office: Molo Ponte Morosini 41/7 - 16126 Genoa, Italy Headquarter: Via Portobello, 12 - 16039 Sestri Levante, Italy Tel:[phone], Fax:[phone] E-mail: [e-mail]

DEC 2 9 2009

# 510(k) Summary

- Mectron S.p.A. Submitter's information Via Loreto 15/A 16042 Carasco (GE), Italy Tel. [phone] Fax [phone] E-mail: [e-mail]
- 510(k) Contact person 2.

1.

4.

Enrico Perfler Executive Manager, Regulatory & Quality Assurance Meditrial s.r.l. Via Aldo Moro, 20 - 25124 Brescia, Italy [phone] Tel: [phone] Fax: [phone] Cell: Email: [e-mail]

#### Summary's date 3.

- Device name and classification

| a. Trade/device name<br>b. Classification name | OSSTEMPiezo<br>Bone cutting instrument and accessories<br>(per 21 CFR section 872.4120)<br>Ultrasonic scaler<br>(per 21 CFR section 872.4850) |
|--------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|
| c. Classification panel<br>d. Regulatory class<br>e. Product code | Dental<br>Class II<br>DZI, ELC |

3 April 2009

#### Device description ട്.

The OSSTEMPiezo uses piezoelectric ultrasonic technology to generate mechanical microvibrations for bone cutting and ultrasonic scaling, with minimal trauma to soft tissue. The device is supplied with rer smoothing and blunt insert tips for use in oral surgery, including implantology, periodontal surgery, endodontic surgery and surgical orthodontics.

## Intendend use/Indications for use 6.

The OSSTEMPiezo is intended for use in the following dental applications:

- Bone cutting for use in oral surgery •
- Removing supra and subgingival calculus deposits and stains from teeth -
- Periodontal pocket lavage with simultaneous ultrasonic tip movement .
- Scaling and root planing -
- Retrograde preparation of root canals -

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**PIEZOSURGERY**®

/K091227

६०१२

Piezosurgery s.r.l. Registered Office: Molo Ponte Morosini 41/7 - 16126 Genoa, Italy Headquarter: Via Portobello, 12 - 16039 Sestri Levante, Italy Tel:[phone], Fax:[phone] E-mail: [e-mail]

#### 7. Predicate device

Piezosurgery® device (K052518).

### 8. Performance evaluations

The device uses piezoeledric ultrasonic technology to generate mechanical microvibrations of insert tips for cutting mineralized structures with minimal trauma to soft tissue and for ultrasonic scaling. The insert tip microvibration results in a safe and effective cut, preserving the osteotomized surfaces, surgical tactile control, reduction of risk of adjacent tissue damage, reduction of tissue heating, and improved post-operative healing. The evaluations demonstrated precisely delineated incisions and the need for limited pressure on the handpiece to achieve the desired cutting action, which improves surgical control and reduces the possibility of trauma to soft tissue.

#### Conclusion 9.

We believe the information provided in this premarket notification support a finding of substantial equivalence between the OSSTEMPiezo and the predicate device Piezosurgery currently marketed.

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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 stylized eagle or bird-like symbol with three curved lines representing its wings or body. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.

# FEB 2 2 2010

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Piezosurgery S.R.L. C/O Mr. Ing. Enrico Perfler Executive Manager. Regulatory and Quality Assurance Meditrial S.R.L. Via Aldo Moro 20 - 25124 Brescia ITALY

Re: K091227

Trade/Device Name: Piezosurgery 3, OSSTEMPiezo Regulation Number: 21CFR 872.4120 Regulation Name: Bone Cutting Instrument and Accessories Regulatory Class: II Product Code: DZI, ELC Dated: December 17, 2009 Received: December 22, 2009

Dear Mr. Perfler:

This letter corrects our substantially equivalent letter of December 29, 2009.

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

for

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):

Device Name: Piezosurgery 3

Indications for Use: The Piezosurgery 3 is intended for use in the following dental applications:

6417

Indications for Use

- Bone cutting for use in oral surgery
- Removing supra and subgingival calculus deposits and stains from teeth
- Periodontal pocket lavage with simultaneous ultrasonic tip movement
- Scaling and root planing
- Retrograde preparation of root canals

RS. Betz DNS for Dr. K.P. Mulky (Acting)
(Division Sign-Off)

Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number. K09/227

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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