(63 days)
No
The description focuses on piezoelectric ultrasonic technology and mechanical vibrations, with no mention of AI or ML.
Yes
The device is described as being used for various dental applications for bone cutting, removing calculus, periodontal pocket lavage, scaling, root planing, and retrograde preparation of root canals, all of which aretherapeutic procedures.
No
The device description and intended use clearly state that it is used for surgical procedures like bone cutting, removing calculus, and root planing, which are therapeutic interventions rather than diagnostic actions. Its functions involve physical alteration or removal of tissue/deposits.
No
The device description explicitly states it uses "piezoelectric ultrasonic technology to generate mechanical microvibrations" and is supplied with "insert tips," indicating it is a hardware device with physical components that perform the intended function.
Based on the provided information, the Piezosurgery® device is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- The Piezosurgery® device is a surgical tool used directly on the patient's body for procedures like bone cutting, scaling, and root planing. It performs physical actions on tissues rather than analyzing biological samples.
The description clearly outlines its use in dental surgical procedures, which falls outside the scope of in vitro diagnostics.
N/A
Intended Use / Indications for Use
The Piezosurgery® device is intended for use in the following dental applications:
- 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 -
Product codes (comma separated list FDA assigned to the subject device)
ELC
Device Description
The Piezosurgery® device 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 sharp, smoothing and blunt insert tips for use in oral surgery, including implantology, periodontal surgery, endodontic surgery and surgical orthodontics.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance and safety evaluations were based on clinical data on the characteristics of the F enomance and Salety Cranadiens wersurely risk of adjacent tissue damage, inselt in Vibration, Suking proclain and on J. The evaluations demonstrated precisely delineated tiosac noating, and the need for limited pressure on the handpiece to achieve the desired cutting inction, which improves surgical control and reduces the possibility of trauma to soft tissue.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
EMS Piezon® Master 600 (K022328)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 872.4850 Ultrasonic scaler.
(a)
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.(b)
Classification. Class II.
0
Piezosurgery 510(k) Summary of Safety and Effectiveness in accordance with 21 CFR 807.92 (c)
Appendix H
| K number: | |
|---|---|
| 1. Submitter's information: | Tomaso Vercellotti, M.D., D.D.S. |
| Piezosurgery s.r.l. | |
| Molo Ponte Morosini 41/7 | |
| 16126 Genoa, Italy | |
| Phone: +39 010 254 1934 | |
| E-mail: perfler@piezosurgery.com | |
| 2. Contact person: | Maria E. Donawa, M.D. |
| Donawa Consulting | |
| P.zza Albania, 10 | |
| 00153 Rome, Italy | |
| Phone: +39 06 578 2665 | |
| E-mail: medonawa@donawa.com | |
| 3. Date summary prepared: | September 1, 2005 |
| 4. Device name and classification: | |
| a. Trade/device name: | Piezosurgery ® |
| b. Classification name: | Ultrasonic scaler |
| (per 21 CFR section 872.4850) | |
| c. Classification panel: | Dental |
| d. Regulatory class: | Class II |
| e. Product code: | ELC |
5. Device description:
Korzz18
The Piezosurgery® device 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 sharp, smoothing and blunt insert tips for use in oral surgery, including implantology, periodontal surgery, endodontic surgery and surgical orthodontics.
6. Intended use:
The Piezosurgery® device is intended for use in the following dental applications:
- Bone cutting for use in oral surgery (K043408) -
- Removing supra and subgingival calculus deposits and stains from teeth -
- Periodontal pocket lavage with simultaneous ultrasonic tip movement -
- Scaling and root planing -
- ﺖ Retrograde preparation of root canals
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7. Predicate device:
EMS Piezon® Master 600 (K022328) for ultrasonic scaling.
8. Substantial equivalence comparison:
Technical, clinical and histologic comparisons presented in this submission support a finding of Technical, billiour and historogio orient Piezosurgery and the predicate device.
9. Performance evaluations:
Performance and safety evaluations were based on clinical data on the characteristics of the F enomance and Salety Cranadiens wersurely risk of adjacent tissue damage, inselt in Vibration, Suking proclain and on J. The evaluations demonstrated precisely delineated tiosac noating, and the need for limited pressure on the handpiece to achieve the desired cutting inction, which improves surgical control and reduces the possibility of trauma to soft tissue.
10. Conclusion:
The performance and safety data presented in this premarket notification support a finding of substantial equivalence between the Piezosurgery device and the predicate device specified in this submission.
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Image /page/2/Picture/1 description: The image is a black and white circular logo. The logo features an emblem of an eagle with three stylized wings. The text "HEALTH & HUMAN SERVICES - USA" is arranged around the top half of the circle, and "DEPARTMENT" is arranged around the bottom half of the circle. The eagle emblem is positioned in the center of the circle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 6 2005
Piezosurgery S.R.L. C/O Ms. Maria E. Donawa Donawa Consulting S.R.L. Piazza Albania 10 00153 Rome, ITALY
Re: K052518
Trade/Device Name: Piezosurgerv® Regulation Number: 872.4850 Regulation Name: Ultrasonic Scaler Regulatory Class: II Product Code: ELC Dated: September 12, 2005 Received: September 14, 2005
Dear Ms. Donawa:
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 application (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 such 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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Page 2 - Ms. Donawa
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); 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.
This letter will allow you to begin marketing your device as described in your Section 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 regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Sujite Y. Michie Omd
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
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KUy218
Indications for Use Statement
510(k) Number:
Device Name:
Piezosurgery®
Indications for Use:
The Piezosurgery® device is intended for use in the following dental applications:
- 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 -
Prescription Use × (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)
Susan Rumm
( Tivision Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devic
510(k) Number: K65
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