(105 days)
Not Found
No
The description focuses on a standard electric motor system for dental applications, with no mention of AI or ML terms or functionalities.
No.
The device is used for mechanical dental procedures (cutting, polishing, filing, etc.) rather than treating a disease or condition with a therapeutic effect.
No
The device is described as being used for general dental applications such as cutting, finishing, filing, polishing, and endodontic treatment, which are therapeutic and procedural actions, not diagnostic ones.
No
The device description explicitly states it is a "device system comprised of a control unit that drives a D.C. brushless micromotor that is activated by means of a footswitch," indicating it includes hardware components (control unit, motor, footswitch).
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states the device is an electric motor kit used for mechanical procedures in dentistry, such as cutting, finishing, and polishing teeth. It operates directly on the tooth.
- Lack of Biological Sample Analysis: There is no mention of the device analyzing any biological samples from the patient.
Therefore, the A-dec/W&H Electric Motor kit falls under the category of a dental device used for direct treatment, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The A-dec/W&H Electric Motor kit is a device system comprised of a control unit that drives a D.C. micromotor that is activated by means of a footswitch. It is indicated for general dental applications such as: cutting a tooth for cavity preparation, finishing, inlay, filing, polishing, prophylaxis and endodontic treatment, with use of a straight, right-angle, or contra-angle ISO E-type handpiece attachment of equal speed, gear-reduction speed, or gear-increasing speed.
Product codes (comma separated list FDA assigned to the subject device)
EBW
Device Description
The A-dec/W&H Electric Motor kit is a device system comprised of a control unit that drives a D.C. micromotor that is activated by means of a footswitch.
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.
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/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the department's name around the perimeter. In the center of the seal is an abstract symbol that resembles an eagle or a bird in flight. The symbol is composed of three curved lines that form the wings and body of the bird.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC - 3 2003
Mr. Tom Louisell A-dec. Incorporation 2601 Crestview Drive Newberg, Oregon 97132
Re: K032572
18052972
Trade/Device Name: A-Dec/ W&H Electric Motor Motor, Model EA-50LT Regulation Number: 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: I Product Code: EBW Dated: November 14, 2003 Received: November 19, 2003
Dear Mr. Louisell:
We have reviewed your Section 510(k) premarket notification of intent to market the device we mayor of the would your 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 Intersule comments prices that have been reclassified in accordance with the provisions of Amendinents, or to actrices that motic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general approvisions of the Act. The general controls provisions of the Act include ennifols provisions of a 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 (1 Mr.), it may be subject to the Code of Federal Regulations, Title 21, Parts 800 to 898. In your device can be nother announcements concerning your device in the Federal Register.
1
Page 2 -Mr. Louisell
Please be advised that FDA's issuance of a substantial equivalence determination does not r lease be act 100 a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. or the rece of ally I outs 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 requirements as betronic 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 (301) 594-4613. 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/dsma/dsmamain.html
Sincercly yours,
Patticia Cucurulloe
Chiu Lin, Ph.D. Director Division of Anesthesiology, Gcneral Hospital, Infection Control and Dental Devices Office of Device Livaluation Center for Devices and Radiological Health
Enclosure
2
510(k) Number (if known):
Device Name: A-dec/W&H Electric Motor
Indications For Use:
The A-dec/W&H Electric Motor kit is a device system comprised of a control unit The A doorward Lloothe micromotor that is activated by means of a footswitch. It that drived a D C Chowneral dental applications such as: cutting a tooth for cavity lo anondou for alle in gown finishing, inlay, filing, polishing, polishing, prophylaxis and endodontic treatment, with use of a straight, right-angle, or contra-angle ISO E-type handpiece attachment of equal speed, gear-reduction speed, or gearincreasing speed.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
OROver-The-Counter Use (Optional Format 1-2-96)
Susan Richard
(Division Sign-Off ion of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number: K032570