The DentaSeptic HPC device is intended as a single use, disposable, transparent, plastic, disposable, non-sterile protective cover to be placed over various high speed and low speed dental handpieces used in the dental/ clinical setting. The cover acts as a physical barrier that assists in providing surface protection for the handpieces, reducing cross contamination of equipment, augmenting existing infection control techniques and making clean up and disinfection less time consuming.

Device Description

The DentaSeptic HPC device is a disposable plastic cover that is made of high density polyethylene (HDPE), that fits over the ends of various high speed and low speed dental handpieces used in the dental/ clinical setting. The cover allows for the attachment and/or protrusion, where applicable, of those parts of the devices that are inserted into the patient's mouth.

AI/ML Overview

This looks like a 510(k) premarket notification for a medical device called DentaSeptic HPC, a disposable cover for dental handpieces. The document is a submission to the FDA, not a study report. Therefore, it does not contain the information requested in your prompt regarding acceptance criteria, study details, expert qualifications, or ground truth establishment.

A 510(k) submission primarily demonstrates substantial equivalence to a legally marketed predicate device rather than providing extensive clinical study data with acceptance criteria in the manner you've described for AI/ML device evaluations. Such submissions often rely on bench testing, material safety, and performance comparisons to predicates, not typically large-scale human-centric studies.

Therefore, I cannot provide the requested information based on the provided text.

Summary

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K031851

510(K) SUMMARY

December 30, 2002

A. Submitter's Name and Address

Bethel, Inc. 320 S. Vine Avenue Tyler Texas, 75702 Telephone (903) 593-0543 Facsimile (903) 533-9561

B. Contact Person
Dr. Eric Wade 320 S. Vine Avenue Tyler Texas, 75702 Telephone (903) 372-1838 Facsimile (903) 533-9561

C. Establishment Registration Number of Submitter

Submitter has not established a registration number

D. Device Name
Proprietary Name: DentaSeptic HPC Common Name: Dental handpiece control barrier

E. Device Description

F. Intended Use: (Indications of Use)

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G. Device Classification

Classification Name: Dental Handpiece and Accessory FDA Classification: Class II per 21 CFR 872.4200 Classification Panel: 76 Classification Product Code: EFB

H. Contract Manufacturing Facility

Manufacturing Address: D&L Tooling & Plastics 950 S. Loop 456 Jacksonville, Texas 75766 Telephone: (903) 586-8357 Facsimile: (800) 227-4829

Mailing Address: D&L Tooling & Plastics P.O. Box 1149 Jacksonville, Texas 75766 Telephone: (903) 586-8357 Facsimile: (800) 227-4829

I. Action Taken to Comply with Section 514 of the Act.
None required under Section 514

J. Reasons for 510(k) Submission

This submission precedes an initial product introduction

K. Predicate Devices

Filmtech, Inc.'s Brixton Infection Control Barrier 510(k) Document Control Number -- K963664

Dentsply International, Inc.'s Disposa-Shield Infection Control Barrier 510(k) Document Control Number -- K900093

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized design featuring three abstract human profiles facing right, with a small star above them.

Public Health Service

AUG - 1 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Dr. Eric Wade Bethel, Incorporated 320 South Vine Avenue Tyler, Texas 75702

Re: K031851

Trade/Device Name: DentaSeptic HPC Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: I Product Code: EFB Dated: June 01, 2003 Received: June 16, 2003

Dear Dr. Wade:

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.

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Page 2 - Dr. Eric Wade

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device ccmplies 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 (301) 594-4613. 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" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained 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

Sincerely yours.

Patricia Cucentifor

Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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INTENDED USE: (INDICATIONS FOR USE)

Intended Use.

Kein Muely for MSV

(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices

510(k) Number: K031851

Regulation Number and Section

§ 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.