(46 days)
Not Found
No
The device description and intended use clearly describe a simple physical barrier made of plastic. There is no mention of any software, data processing, or intelligent capabilities. The "Not Found" entries for AI/ML mentions, image processing, training/test sets, and performance studies further confirm the absence of AI/ML.
No
The device is described as a protective cover for dental handpieces, intended to provide surface protection and reduce cross-contamination. Its function is to augment infection control and facilitate cleaning, not to directly treat or diagnose a medical condition.
No
The device is a protective cover for dental handpieces, intended to act as a physical barrier for infection control. It does not perform any diagnostic function such as detecting, analyzing, or identifying diseases or conditions.
No
The device is described as a physical, disposable plastic cover, indicating it is a hardware device, not software.
Based on the provided information, the DentaSeptic HPC device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- DentaSeptic HPC Function: The DentaSeptic HPC device is described as a protective cover for dental handpieces. Its purpose is to act as a physical barrier to reduce cross-contamination and aid in infection control. It does not analyze any biological specimens.
The intended use and device description clearly indicate that this device is a physical barrier for equipment, not a diagnostic tool that analyzes samples from the body.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
EFB
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.
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
dental/ clinical setting
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
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
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.
F. Intended Use: (Indications of Use)
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.
1 0
1
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.
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.
Kein Muely for MSV
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number: K031851