(86 days)
No
The summary describes a mechanical drive unit with a pump for dental surgery, with no mention of AI or ML capabilities.
Yes
The device is described for "treatment of dental hard tissue" in dental surgery, implantology, and maxillo-facial surgery, which indicates a therapeutic purpose.
No
The device is described as a "Mechanical drive unit with coolant supply for transmission instruments" used for "treatment of dental hard tissue." It is a drive unit and not mentioned to diagnose any condition.
No
The device description explicitly lists 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:
- Intended Use: The intended use is for "Mechanical drive unit with coolant supply for transmission instruments... for use in dental surgery, implantology and maxillo-facial surgery for treatment of dental hard tissue." This describes a device used directly on the patient for a surgical procedure.
- Device Description: The description details a "small hand held motor, a foot control and a controller" with an integrated pump for coolant. This is consistent with a surgical or procedural device, not a device used to examine samples in vitro (outside the body).
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, tissue, etc.), detecting markers, or providing diagnostic information based on laboratory tests.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is mechanical and procedural, not 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 and maxillo-facial surgery for treatment of dental hard tissue.
Product codes
EBW
Device Description
The device consists of a small hand held motor, a foot control and a controller. Accessories complete the device. They are designed for use in dental surrery. Optimum irrigation of the treatment site is an important factor for successful treatment. An integrated pump is used to supply the treatment fluid / oooolant 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 and maxillo-facial surgery
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)
implantMED SI-95 (K002469), implantmed SI 915/923 ( K052741)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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/0 description: The image shows the logo for W&H Dentalwerk. The logo consists of the letters "W&H" inside of a hexagon on the left, and the word "DENTALWERK" on the right. The text is in bold, sans-serif font.
3 2006 MAY 510(k) Section 5
abel Versions of "implantMED Si-915/923"
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: | 01/20/2006 |
| Device name: | Private Label Versions of "implantMED SI-915/923"
Such as "DrillTech", "Ism", " Implant Unit" and "Zimmer
Surgical Motor Unit" |
| Common Name: | Surgical motor unit for implantology and maxillo
surgery |
| Classification Name: | Controller, foot, handpiece and cord |
| Predicate devices: | implantMED SI-95 (K002469)
implantmed SI 915/923 ( K052741) |
Device Description:
The device consists of a small hand held motor, a foot control and a controller. Accessories complete the device. They are designed for use in dental surrery. Optimum irrigation of the treatment site is an important factor for successful treatment. An integrated pump is used to supply the treatment fluid / oooolant 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 and maxillo-facial surgery for treatment of dental hard tissue.
Technological Characteristics:
The technological characteristics of the private label versions are very similar to the previous implantMED versions. Differences result from the modification of the Intended Use and become manifest in programs and factory settings. Furthermore we offer an alternative foot control.
Substantial equivalence:
The private label versions and the predicate device "implantMED SI-95" share the same indication for use.
1
The comparison of the subject and the predicate device "implantMED SI-915/923" shows very similar technological characteristics. Performance properties and biocompatibility are the same.
The private label versions are substantially equivalent to those devices it was modified from.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol featuring three abstract human profiles facing to the right, with three parallel lines above them.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 3 2006
Ms. Gabriele Wienbeck Regulatory Affairs W&H Dentalwerk Büermoos GmbH Ignaz Glaser Strasse 53 Büermoos, Austria A-5111
Re: K060287
Trade/Device Name: Private Label Versions of implantMED SI-915/923 including accessories such as "Drilltech" "Ism" "ImplantUnit" "Zimmer Surgical Motor Unit" Regulation Number: 872.4200
Regulation Name: Dental Handpiece and Accessories Regulatory Class: I
Product Code: EBW Dated: February 2, 2006
Received: February 7, 2006
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.
3
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,
Clue
Chiu Lin, Ph.D.
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
4
| W&H | DENTALWERK |
|---|---|
| ----- | ------------ |
INDICATION FOR USE
510(k) (if known):____________________________________________________________________________________________________________________________________________________________ Device Name: Private Label Versions of implantMED SI-915/923 incl. accessories such as "Drilltech" "Ism" "ImplantUnit" "Zimmer Surgical Motor Unit" 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 and maxillo-facial surgery for treatment of dental hard tissue.
Prescription Use (Part 21 CFR 801 Subpart D)
X
AND/OR
Over- The -Counter Use (21 CFR 807 Subpart C)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Roe Muler for MCR
Technology, General Hospital,
Control, Luminal Devices