(128 days)
Not Found
No
The description details a standard electrically controlled screwdriver with adjustable torque, battery, and mechanical components. There is no mention of AI/ML terms, image processing, or data-driven performance metrics.
No
The device is described as an "electrically controlled screwdriver with adjustable torques to tighten and unscrew prosthodontic screws." Its function is mechanical in nature, used to assemble and disassemble dental prosthetics, which is not considered a therapeutic function.
No
This device is an electrically controlled screwdriver used to tighten and unscrew prosthodontic screws, indicating it is an operative device rather than a diagnostic one.
No
The device description clearly outlines physical hardware components including a cordless drive unit, mechanical transmission instrument, contra-angle attachment, key pad, battery, and charging station. It is a physical medical device with embedded software for control.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The device is described as an "electrically controlled screwdriver with adjustable torques to tighten and unscrew prosthodontic screws." This is a mechanical function performed directly on a patient's dental prosthesis, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The description details a cordless drive unit, mechanical transmission, battery, and controls for torque and rotation. This aligns with a surgical or procedural tool, not an in vitro diagnostic device.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on laboratory testing.
The device is clearly intended for use in a dental setting for a mechanical procedure related to prosthodontics.
N/A
Intended Use / Indications for Use
The drive unit is an electrically controlled screwdriver with adjustable torques to tighten and unscrew prosthodontic screws. Consisting of: - Cordless drive unit - Mechanical transmission instrument 80:1
Product codes (comma separated list FDA assigned to the subject device)
EKX
Device Description
The cordless Prosthodontic Screwdriver IA-400 consists of the cordless drive IA-40H, the contra-angle attachment IA-80 and a key pad (finger switch).
The drive is fitted out with a 3.7 V Li-Ion battery, which can be re-charged using the provided charging station.
The drive and the contra-angle attachment are connected via a special coupling, based on ISO 3964.
By means of the different buttons on the drive the user controls the various settings, such as ON, forward/reverse and the torque. The attached key pad (finger switch) allows starting and stopping the screwdriver's rotation.
The handpiece's application is intended in dentistry.
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
dentistry
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)
W&H's Prosthodontic Screwdriver IA-400 was developed and is produced under consideration of all applicable technical standards and quality management directives. The product's conformance with the applicable technical standards was verified in the course of type testing. Bench testing results demonstrated substantially equivalence. Perfect functionality and accuracy of all serial devices are controlled in the final step of production.
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
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ે.
વર્ષના વિદ્યાર્થો વિભાગના પાકની ખેત
ﺗ
Section 5
Page 1 of 2
JUL·- 9 2010
510(k) SUMMARY
| Applicant and Owner | W&H Dentalwerk Buermoos GmbH
Ignaz-Glaser-Strasse 53
A - 5111 Buermoos
Austria
Tel.: 0043 -6274 / 6236 -297
Fax: 0043 -6274 / 6236 -234 |
|---------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Johann Georg SCHARL |
| Date of Submission | March 1st, 2010 |
| Device Name | Prosthodontic Screwdriver IA-400 |
| Classification Name | Handpiece, Direct Drive, Ac-Powered |
| Regulation Number | 21 CFR872.4200 |
| Product Code | EKX |
| Predicate Devices | - "implantMED SI-915", cleared by W&H Dentalwerk Buermoos under K052741
- "WS-75 E/KM", cleared by W&H Dentalwerk Buermoos as an accessory to the
"implantMED SI-915" in file K052741
- Cordless Endo Handpc. "ENTRAN", W&H Dentalwerk Buermoos, K090931 |
| Device Description | The cordless Prosthodontic Screwdriver IA-400 consists of the
cordless drive IA-40H, the contra-angle attachment IA-80 and a
key pad (finger switch).
The drive is fitted out with a 3.7 V Li-Ion battery, which can be re-
charged using the provided charging station.
The drive and the contra-angle attachment are connected via a
special coupling, based on ISO 3964.
By means of the different buttons on the drive the user controls
the various settings, such as ON, forward/reverse and the torque.
The attached key pad (finger switch) allows starting and stopping
the screwdriver's rotation.
The handpiece's application is intended in dentistry. |
| Intended Use: | The drive unit is an electrically controlled screwdriver with
adjustable torques to tighten and unscrew prosthodontic screws.
Consisting of:
- Cordless drive unit
- Mechanical transmission instrument 80:1 |
July 8th, 2010
1
| Image: W&H logo | 510(k)
Prosthodontic Screwdriver IA-400 | Section 5
Page 2 of 2 |
| ----------------- | -------------------------------------------- | -------------------------- |
|---|
| Technological
Characteristics | W&H's "Prosthodontic Screwdriver IA-400" represents a device
combining the technical principle of the cordless ENDO-
Handpiece "ENTRAN" (510(k) no. K090931) with a special field of
applicability of W&H's drive unit "implantMED SI-915", provided
with the contra-angle handpiece attachment type WS-75 E/KM
(both cleared for market under 510(k) K052741). |
|--------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Comparison of the
device to the predicate
device | The advantage of the new product is based, above all, on the fact
that the "Prosthodontic Screwdriver IA-400" was designed for a
detail of the "implantMED's" applicability. So it offers advantages
with respect to usability and flexibility: cordless, less weight,
smaller size, better balanced, ergonomically designed. |
| | The intended purpose of the predicate device "implantMED"
covers the new device's intended use; "implantMED's"
performance parameters are very similar in this respect to the
new device's ones.
The technological characteristics and materials, on the other
hand, are very similar to those of the predicate device "ENTRAN". |
| | With respect to the functions considered as intended use, the new
device can be judged to be substantially equivalent to the
predicate devices. |
| Performance Testing | W&H's Prosthodontic Screwdriver IA-400 was developed and is
produced under consideration of all applicable technical
standards and quality management directives. |
| | The product's conformance with the applicable technical
standards was verified in the course of type testing. Bench testing
results demonstrated substantially equivalence. Perfect
functionality and accuracy of all serial devices are controlled in the
final step of production. |
| | Corresponding certificates and the application of the CE-mark
give evidence of the product's high quality. |
| Clinical Testing | Clinical data were not needed for this new product. |
July 8th, 2010
.
:
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ﺎ ﻟﻠﻬ
ﺮﺓ ﺍﻟﻘﺮﻥ ﺍﻟﻤﺮﺍﺟﻊ ﺍﻟﻤﺮﺍﺟﻊ
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
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 with three stripes representing the department's mission. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Mr. Johann G. Scharl Regulatory Affairs Manager W & H Dentalwerk Buermoos GMBH 53 Ignaz-Glaser- Strasse Buermoos Austria 5111
JUL - 9 2010
Re: K100600
Trade/Device Name: Prosthodontic Screwdriver IA-400 Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: I Product Code: EKX Dated: June 25, 2010 Received: June 25, 2010
Dear Mr. Scharl:
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.
3
Page 2- Mr. Scharl
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.goy/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.
h 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
4
[W&H]
510(k)
Prosthodontic Screwdriver IA-400
Section 4
Page 1 of 1
`[K100600](https://510k.innolitics.com/search/K100600)`
Indications for Use
| Labels | Values |
|-------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) number: | not known yet |
| Device Name: | Prosthodontic Screwdriver IA-400 |
| Indication for Use: | The drive unit is an electrically controlled screwdriver with adjustable torques to tighten and unscrew prosthodontic screws. Consisting of: - Cordless drive unit - Mechanical transmission instrument 80:1 |
| Labels | Values |
|--------------------------------------------------|-------------------------|
| Prescription Use (Part 21 CFR 801 Subpart D) | X |
| Over The Counter Use (Part 21 CFR 807 Subpart C) | |
AND/OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
Kein Muluy for MSR
(Division Sign-Off)
Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: [K100600](https://510k.innolitics.com/search/K100600)
.. '