(105 days)
Not Found
No
The summary describes a mechanical drive unit with a pump and motor, and explicitly states that AI, DNN, or ML were not found in the description.
Yes
Explanation: The device is described as a drive unit for use in dental surgery, implantology, maxillo-facial surgery, and endodontics for the treatment of dental hard tissue and mechanical rotating root canal preparation, indicating it provides therapy.
No
The device description states it is a "Mechanical drive unit with coolant supply for transmission instruments" used for "treatment of dental hard tissue and mechanical rotating root canal preparation." This indicates it is a therapeutic or surgical device, not one that gathers or analyzes data for diagnosis.
No
The device description explicitly mentions hardware components such as a hand held motor, foot control, controller, and an integrated pump.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside the body (in vitro).
- Device Function: The description clearly states the device is a "Mechanical drive unit with coolant supply for transmission instruments" used in dental procedures. It's a tool used directly on the patient for treatment (drilling, preparing root canals).
- Lack of Specimen Analysis: There is no mention of the device analyzing any biological specimens taken from the patient. Its function is mechanical and involves direct interaction with the patient's tissues.
Therefore, this device falls under the category of a surgical or dental instrument, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Mechanical drive unit with coolant supply for transmission instruments with coupling system according to ISO 3964. The equipment is a drive unit for use in dental surgery, implantology, maxillo-facial surgery and endodontics for treatment of dental hard tissue and mechanical rotating root canal preparation
Product codes (comma separated list FDA assigned to the subject device)
EBW
Device Description
The implantMED SI-915/923 consist of a small hand held motor, a foot control and a controller. Accessories complete the device. They are designed for use in dental surgery.
Optimum irrigation of the treatment site is an important factor for successful treatment. An integrated pump is used to supply the treatment fluid / coolant from its reservoir via a pump to the motor / handpiece.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
dental hard tissue
Indicated Patient Age Range
Not Found
Intended User / Care Setting
dental surgery, implantology, maxillofacial surgery and endodontics
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.
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
§ 872.4200 Dental handpiece and accessories.
(a)
Identification. A dental handpiece and accessories is an AC-powered, water-powered, air-powered, or belt-driven, hand-held device that may include a foot controller for regulation of speed and direction of rotation or a contra-angle attachment for difficult to reach areas intended to prepare dental cavities for restorations, such as fillings, and for cleaning teeth.(b)
Classification. Class I.
0
Image /page/0/Picture/2 description: The image shows the logo for W&H DENTALWERK. The logo consists of two parts: a hexagon containing the letters "W&H" and the word "DENTALWERK" written in bold, sans-serif font. The hexagon is located to the left of the word "DENTALWERK". The logo is simple and professional, and it is likely used to represent a dental company or organization.
510(k) implantMED SI-915/923
Section 5 Page 1 of 1
510(k) SUMMARY
| Submitted by: | W & H Dentalwerk Buermoos GmbH
Ignaz-Glaser-Strasse 53
A - 5111 Buermoos
Austria |
|----------------------|-------------------------------------------------------------------------------------------|
| Contact person: | Gabriele Wienbeck
Tel.: +43-6274-6236-397
Fax: +43-6274-6236-234 |
| Date of Preparation: | 15/08/2005 |
| Device name: | implantMED SI-915/923 |
| Common Name: | Surgical motor unit for implantology and maxill
surgery |
| Classification Name: | Controller, foot, handpiece and cord |
| Predicate device: | implantMED (K002469) |
Device Description:
The implantMED SI-915/923 consist of a small hand held motor, a foot control and a controller. Accessories complete the device. They are designed for use in dental surgery.
Optimum irrigation of the treatment site is an important factor for successful treatment. An integrated pump is used to supply the treatment fluid / coolant from its reservoir via a pump to the motor / handpiece.
Intended use:
Mechanical drive unit with coolant supply for transmission instruments with coupling system according to ISO 3964.
The equipment is a drive unit for use in dental surgery, implantology, maxillofacial surgery and endodontics for treatment of dental hard tissue and mechanical rotating root canal preparation.
Technological Characteristics:
The "implantMED SI-915/923" is the update of the previous version. The technological characteristics are very similar to the old device.
Substantial equivalence:
The updated and the predicate device share the same indication for use. Comparisons of the subject and the previous version show similar technological characteristics, performance properties and biocompatibility. The "implantMED SI-915/923" is substantially equivalent to the device it was modified from, the "implantMED SI-95"
1
Image /page/1/Picture/1 description: The image shows the logo for the Department of Health and Human Services, USA. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or movement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN I 3 2006
Ms. Gabriele Wienbeck Regulatory Affairs W&H Dentalwerk Buermoos GmbH Ignaz-Glaser Strasse 53 A-5111 Büermoos AUSTRIA
Re: K052741
Trade/Device Name: ImplantMED SI-915 (115V Version) ImplantMED SI-923 (230V Version) Incl. Accessories Regulation Number: 872.4200 Regulation Name: dental Handpiece and Accessories Regulatory Class: I Product Code: EBW Dated: December 16, 2005 Received: December 16, 2005
Dear Ms. Wienbeck:
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.
2
Page 2 - Ms. Wienbeck
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,
Suyle y. Michael Davis
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
Enclosure
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Image /page/3/Picture/0 description: The image shows a logo with the letters "W&H" inside of a hexagon. To the right of the logo, the word "DENT" is written in bold, sans-serif font. The logo and the word are both in black and white.
INDICATION FOR USE
510(k) (if known):_____________K052741
Device Name: implantMED SI-915 (115V version) implantMED SI-923 (230V version) incl. accessories
Indication for Use:
Mechanical drive unit with coolant supply for transmission instruments with coupling system according to ISO 3964. The equipment is a drive unit for use in dental surgery, implantology, maxillo-facial surgery and endodontics for treatment of dental hard tissue and mechanical rotating root canal preparation
Prescription Use × (Part 21 CFR 801 Subpart D)
AND/OR
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Over- The -Counter Use________________________________________________________________________________________________________________________________________________________ (21 CFR 807 Subpart C)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Russe
ന്റേറ്റ് അവനം on Corrist, Dental Devices