K Number
K971732
Device Name
DENTAL HANDPIECE
Date Cleared
2000-01-11

(977 days)

Product Code
Regulation Number
872.4200
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
AS ALL OTHER DENTAL HANDPIECES, WILL THIS DENTAL HANDPIECE, BE USED INTRA AND EXTRA ORALLY TO CENTAL DEVICES CRIND AND POLISH TEETH, OR ITEMS RELATED TO TEETH AND DENTAL DEVICES THAT MAY BE IN THE MOUTH OR TO BE PLACED IN THE MOUTH.
Device Description
THE DENTAL HANDPIECE, PATENT NUMBER 5575647, WAS DESIGNED TO INTRA-ORALLY, ALIGNED WITH THE LONG AXIS OF EACH TOOTH. THIS EASE OF ALIGNMENT IN ALL AREAS OF THE MOUTH DECIDEDLY GIVES THE HANDPIECE A SAFETY MARGIN OVER ANY EXISTING HIGHSPEED HANDPIECE, UPON WHICH THE SUBSTANTIAL EQUIVALENCE IS BASED. ALL DENTAL HANDPIECES, SINCE THEIR INCEPTION IN THE LATE 1800'S, HAVE BEEN CONSRUCTED OF THE SAME MATERIALS: BRASS AND CHROME,OR STAINLESS, OR A COMBINATION OF BOTH. AALL DENTAL HANDPIECES HAVE BEEN BOTH DURABLE AND SAFE.
More Information

Not Found

Not Found

No
The description focuses on the mechanical design, materials, and intended use of a dental handpiece, with no mention of AI or ML capabilities.

No
The device is used to grind and polish teeth, which are procedures rather than therapeutic interventions aimed at treating a disease or condition.

No

Explanation: The "Intended Use" section states the device "CRIND AND POLISH TEETH, OR ITEMS RELATED TO TEETH AND DENTAL DEVICES." This describes a restorative or procedural function, not a diagnostic one. There is no mention of identifying, measuring, or analyzing any condition or disease.

No

The device description explicitly describes a physical dental handpiece constructed of materials like brass, chrome, and stainless steel, indicating it is a hardware device.

Based on the provided text, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use clearly states the device is used "INTRA AND EXTRA ORALLY TO CENTAL DEVICES CRIND AND POLISH TEETH, OR ITEMS RELATED TO TEETH AND DENTAL DEVICES THAT MAY BE IN THE MOUTH OR TO BE PLACED IN THE MOUTH." This describes a mechanical action on teeth and dental items, not a diagnostic test performed on biological samples in vitro (outside the body).
  • Device Description: The description focuses on the physical construction and function of a dental handpiece for grinding and polishing. It does not mention any components or processes related to analyzing biological samples.
  • Lack of IVD Indicators: The text does not mention any of the typical characteristics of an IVD, such as:
    • Analysis of biological samples (blood, urine, tissue, etc.)
    • Detection or measurement of analytes
    • Diagnostic purposes (identifying diseases, conditions, etc.)
    • Reagents or test kits

Therefore, this device is a dental tool used for mechanical procedures, not an in vitro diagnostic device.

N/A

Intended Use / Indications for Use

AS ALL OTHER DENTAL HANDPIECES, WILL THIS DENTAL HANDPIECE, BE USED INTRA AND EXTRA ORALLY TO CENTAL DEVICES CRIND AND POLISH TEETH, OR ITEMS RELATED TO TEETH AND DENTAL DEVICES THAT MAY BE IN THE MOUTH OR TO BE PLACED IN THE MOUTH.

Product codes

EFB

Device Description

THE DENTAL HANDPIECE, PATENT NUMBER 5575647, WAS DESIGNED TO INTRA-ORALLY, ALIGNED WITH THE LONG AXIS OF EACH TOOTH. This ease of alignment in all areas of the mouth decidedly gives the handpiece a safety margin over any existing highspeed handpiece, upon which the substantial equivalence is based. All dental handpieces, since their inception in the late 1800's, have been consructed of the same materials: brass and chrome,or stainless, or a combination of both. AALL DENTAL HANDPIECES HAVE BEEN BOTH DURABLE AND SAFE.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Intra-oral, teeth

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

§ 872.4200 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

JAN 1 1 2000

510(k) SUMMARY OR STATEMENT

THE DEVICE CONCERNED IS 510(k) NUMBER K971732, DENTAL HANDPIECE.

THE DENTAL HANDPIECE, PATENT NUMBER 5575647, WAS DESIGNED TO INTRA-ORALLY, ALIGNED WITH THE LONG AXIS OF EACH TOOTH. THIS EASE OF ALIGNMENT IN ALL AREAS OF THE MOUTH DECIDEDLY GIVES THE HANDPIECE A SAFETY MARGIN OVER ANY EXISTING HIGHSPEED HANDPIECE, UPON WHICH THE SUBSTANTIAL EQUIVALENCE IS BASED.

ALL DENTAL HANDPIECES, SINCE THEIR INCEPTION IN THE LATE 1800'S, HAVE BEEN CONSRUCTED OF THE SAME MATERIALS: BRASS AND CHROME,OR STAINLESS, OR A COMBINATION OF BOTH. AALL DENTAL HANDPIECES HAVE BEEN BOTH DURABLE AND SAFE.

1

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

'JAN 1 1 2000

Dr. Kenneth Grubbs, D.D.S. 101 Davis Street Monroe, Georgia 30655

K971732 Re : Dental Handpiece Trade Name: Requlatory Class: I Product Code: EFB Dated: October 21, 1999 Received: October 25, 1999

Dear Dr. Grubbs:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any

2

Page 2 - Dr. Grubbs

obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fdaygov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

3

510(K) #971732

STATEMENT OF INDICATIONS FOR USE

THIS IS A STATEMENT OF INDICATIONS FOR USE, CONCERNING 510(K) NUMBER K971732, DENTAL HANDPIECE.

AS ALL OTHER DENTAL HANDPIECES, WILL THIS DENTAL HANDPIECE, BE USED INTRA AND EXTRA ORALLY TO CENTAL DEVICES CRIND AND POLISH
TEETH, OR ITEMS RELATED TO TEETH AND DENTAL DEVICES THAT MAY BE IN THE MOUTH OR TO BE PLACED IN THE MOUTH.

Susan Runyon

(Division Sign-Off) (Division of Dental, Infection Control, and General Hospital 510(k) Number

Prescription Use _ (Per 21 CFR 801.109)