(127 days)
Not Found
Not Found
No
The summary describes a piezoelectric ultrasonic device for surgical and scaling procedures, with no mention of AI or ML capabilities.
Yes
The device is used for bone cutting, osteotomy, and scaling applications, which are considered therapeutic procedures in dentistry.
No
The device description and intended use outline procedures for cutting, drilling, scaling, and various dental treatments, all of which are interventional or therapeutic, not diagnostic.
No
The device description explicitly states it is a "piezoelectric ultrasonic device, consisting of handpieces and associated tip inserts," indicating it is a hardware device with physical components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes procedures performed directly on the patient's body (bone cutting, scaling, etc.) within the oral cavity. IVDs are used to examine specimens outside the body (in vitro) to provide information about a patient's health.
- Device Description: The device description focuses on the physical components used for these surgical and scaling procedures.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any other elements typically associated with in vitro diagnostics.
Therefore, the Piezosurgery Touch is a medical device used for surgical and dental procedures, not an IVD.
N/A
Intended Use / Indications for Use
Piezosurgery Touch is a piezoelectric ultrasonic device, consisting of handpieces and associated tip inserts, intended for:
- Bone cutting, osteotomy, osteoplasty and drilling in a variety of oral surgical procedures, including implantology, periodontal surgery, surgical orthodontic, and surgical endodontic procedures;
- Scaling applications, including:
- Scaling: All general procedures for removal of supragingival and interdental calculus & plaque deposits;
- Periodontology: Periodontal therapy and debridement for all types of periodontal diseases, including periodontal pocket irrigation and cleaning;
- Endodontics: All treatments for root canal reaming, irrigation, filling, gutta-percha condensation and retrograde preparation;
- Restorative and Prosthetics: Cavity preparation, removal of prostheses, amalgam condensation, finishing of crown preparations and inlay/onlay condensation.
Product codes (comma separated list FDA assigned to the subject device)
DZI, ELC
Device Description
Piezosurgery Touch is a piezoelectric ultrasonic device, consisting of handpieces and associated tip inserts
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)
Not Found
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.
Not Found
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.
Not Found
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
§ 872.4120 Bone cutting instrument and accessories.
(a)
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.(b)
Classification. Class II.
0
medical technology
DEC 0 6 2012
Mectron S. p.A. Via Loreto, 15/A 16042 Carasco - GE (Italy) Tel. +39 0185 35361 Fax +39 0185 351374 www.mectron.com
P.IVA IT00177110996 N. Iscr. Reg. Imprese Genova e C.Fisc .: 01126960101 R.E.A. Genova 253624 Cap. Soc. Euro 1.400.000 i.v. mectron@mectron.com
510(k) Summary in accordance with 21 CFR 807.92
Device Name:
Piezosurgery Touch
Traditional
July 30, 2012
Mectron Spa
3003933619
Mectron Spa
Roger Gray
Italy
Italy
Via Loreto, 15, 16042 Carasco - (GE)
Via Loreto, 15, 16042 Carasco - (GE)
VP, Quality and Regulatory Donawa Lifescience Consulting Piazza Albania, 10, 00153 Rome, Italy
Manufacturer:
Date of Submission:
FDA Registration Number:
Type of 510(k) submission:
510(k) Owner:
510(k) Contact:
Trade name:
Piezosurgery Touch
Drill, Bone, Powered Ultrasonic scaler
21 CFR 872.4120
Dental
Class II
DZI ELC
Tel: +39 06 578 2665 Fax: +39 06 574 3786
Common Name/Regulation Description: Bone cutting instrument and accessories Ultrasonic scaler
Device Classification Name
Classification Regulation:
FDA Panel:
Product Codes:
Class:
510(k) for Piezosurgery Touch - K122322
1
Image /page/1/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" in bold, uppercase letters. The text is centered and takes up most of the image. The font is a serif typeface.
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines forming its body and wings. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
December 6, 2012
Mectron S.PA. C/O Mr. Roger Gray Vice President, Quality and Regulatory Donawa Lifescience Consulting Srl Piazza Albania, 10 Rome, Italy 00153
Re: K122322
Trade/Device Name: Piezosurgery Touch Regulation Number: 21 CFR 872.4120 Regulation Name: Bone Cutting Instrument and Accessories Regulatory Class: II Product Code: DZI, ELC Dated: November 30, 2012 Received: December 3, 2012
Dear Mr. Gray:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling.must be truthful and not misleading.
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.
2
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Kwame O. Ulmer
Anthony D. Watson, B.S., M.S., M.B.A. Director
Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices
Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use Statement
Indications for Use
510(k) Number (if known): K122322
Device Name: Piezosurgery Touch
Indications for Use: Piezosurgery Touch is a piezoelectric ultrasonic device, consisting of handpieces and associated tip inserts, intended for:
- · Bone cutting, osteotomy, osteoplasty and drilling in a variety of oral surgical procedures, including implantology, periodontal surgery, surgical orthodontic, and surgical endodontic procedures;
- · Scaling applications, including:
- · Scaling: All general procedures for removal of supragingival and interdental calculus & plaque deposits;
- · Periodontology: Periodontal therapy and debridement for all types of periodontal diseases, including periodontal pocket irrigation and cleaning;
- · Endodontics: All treatments for root canal reaming, irrigation, filling, gutta-percha condensation and retrograde preparation;
- · Restorative and Prosthetics: Cavity preparation, removal of prostheses, amalgam condensation, finishing of crown preparations and inlay/onlay condensation.
| Prescription Use | AND/OR | Over-The-Counter Use | |
|---|---|---|---|
| (Part 21 CFR 801 Subpart D) | (21 CFR 801 Subpart C) |
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
2012.12.06
Susan Runner DDS, MA
12:17:02 -05'00'
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Davices
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510(k) Number: