(72 days)
Not Found
No
The device description and intended use describe a simple mechanical device with no mention of AI or ML capabilities. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
No
The description indicates it is a cleansing device for removing plaque and food, intended for personal oral hygiene use, and is substantially equivalent to other plaque removers. It is not described as treating or preventing a specific disease or condition beyond general oral hygiene.
No
Explanation: The device is described as an "effective cleansing device which removes plaque and food between the teeth." Its intended use is for "personal oral hygiene use" and it supplements "regular professional care." There is no mention of it being used to diagnose conditions or diseases.
No
The device description explicitly states it is a "plastic product" with a "handle" and "points," indicating it is a physical, hardware-based device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for personal oral hygiene to remove plaque and food between teeth. This is a mechanical action performed directly on the body (or in this case, the teeth and gums), not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The device is a simple plastic tool with points for scraping. It doesn't involve any reagents, assays, or analysis of biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Testing of biological samples (blood, urine, saliva, etc.)
- Diagnosis, monitoring, or screening of diseases or conditions
- Use of reagents or analytical methods
- Measurement of biomarkers or other biological indicators
The device is clearly intended for physical cleaning and is classified as a personal oral hygiene product, similar to a toothpick or dental floss.
N/A
Intended Use / Indications for Use
The Plaque Scraper-A Interproximal (between teeth) Plaque Remover is an effective cleansing device, which removes plaque and food from between the teeth as part of a program for good oral hygiene to supplement the regular professional care required for oral health. This product is intended for personal oral hygiene use.
Product codes (comma separated list FDA assigned to the subject device)
JET, EMN
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
between the teeth
Indicated Patient Age Range
Not Found
Intended User / Care Setting
personal oral hygiene use
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)
The information in the Premarket Notification on safety and effectiveness supports a finding of substantial equivalence to devices already in commercial distribution. Equivalence is demonstrated through intended use, materials and design.
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
§ 872.4565 Dental hand instrument.
(a)
Identification. A dental hand instrument is a hand-held device intended to perform various tasks in general dentistry and oral surgery procedures. The device includes the operative burnisher, operative amalgam carrier, operative dental amalgam carver, surgical bone chisel, operative amalgam and foil condenser, endodontic curette, operative curette, periodontic curette, surgical curette, dental surgical elevator, operative dental excavator, operative explorer surgical bone file, operative margin finishing file, periodontic file, periodontic probe, surgical rongeur forceps, surgical tooth extractor forceps, surgical hemostat, periodontic hoe, operative matrix contouring instrument, operative cutting instrument, operative margin finishing periodontic knife, periodontic marker, operative pliers, endodontic root canal plugger, endodontic root canal preparer, surgical biopsy punch, endodontic pulp canal reamer, crown remover, periodontic scaler, collar and crown scissors, endodontic pulp canal filling material spreader, surgical osteotome chisel, endodontic broach, dental wax carver, endodontic pulp canal file, hand instrument for calculus removal, dental depth gauge instrument, plastic dental filling instrument, dental instrument handle, surgical tissue scissors, mouth mirror, orthodontic band driver, orthodontic band pusher, orthodontic band setter, orthodontic bracket aligner, orthodontic pliers, orthodontic ligature tucking instrument, forceps, for articulation paper, forceps for dental dressing, dental matrix band, matrix retainer, dental retractor, dental retractor accessories, periodontic or endodontic irrigating syringe, and restorative or impression material syringe.(b)
Classification. Class I (general controls). If the device is made of the same materials that were used in the device before May 28, 1976, it is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.
0
Section 5: 510(k) Summary
Submitted By: 1.0
MAR 2 9 2007
Kevin Vu, DDS 2755 S. Nellis #12 Las Vegas, NV 89121 Establishment Registration Number: Pending
Primary Contact:
Glen Feye President Accurate Consultants, Inc. 1340 West Pennsylvania Ave. San Diego, CA 92103 Telephone: 619-517-1762 Fax: 619-393-0582 glenfeye@earthlink.net
2.0 Date Submitted:
December 20, 2006
3.0 Device Name(s):
3.1 Proprietary Names
Plaque Scraper-A Interproximal (between teeth) Plaque Remover
Classification Name 3.2
21 CFR 872.6650 (Massaging pick or tip for oral hygiene) Product code - JET (Pick, Massaging).
1
K0 70127
2083
4.0 Predicate Devices:
| Candidate | Predicate | Manufacturer | Docket
Number |
|-------------------------------------------------------------------------|-------------------------------------|----------------------------------|------------------|
| Plaque Scraper-
A Interproximal
(between teeth)
Plaque Remover | Reach Stim-U-Dent
Plaque Remover | Whitehill
Manufacturing, Inc. | K963747 |
5.0 Intended Use:
The Plaque Scraper-A Interproximal (between teeth) Plaque Remover is an effective cleansing device, which removes plaque and food from between the teeth as part of a program for good oral hygiene to supplement the regular professional care required for oral health. This product is intended for personal oral hygiene use.
6.0 Comparison to Predicate(s):
The following tables show similarities and differences between the predicate identified in Section 4.0 of this summary.
| Product | Aspect/Characteristic | Comments |
|---|---|---|
| Plaque | ||
| Scraper | Basic Intended Use | Similar to Stim-U- |
| Dent Plaque | ||
| Remover | ||
| Basic Instructions for Use | ||
| Provided Non-Sterile | ||
| Rigid Material | ||
| Beveled Edge Design | ||
| Contraindications for Use |
Similarities to the Predicate
2
K070127
393
| Product | Aspect/Characteristic | Comments |
|---|---|---|
| Plaque | ||
| Scraper | Material Composition | The Stim-U-Dent product is a bass |
| wood based product whereas the | ||
| Plaque Remover is a plastic product. | ||
| Plaque | ||
| Scraper | Design | The Stim-U-Dent product is a |
| toothpick shaped product with a | ||
| beveled point on one end whereas | ||
| the Plaque Remover is designed | ||
| with an elongated handle for | ||
| ergonomic convenience and has | ||
| dual rounded and beveled points on | ||
| each end. |
Differences from the Predicate
7.0 Summary of Performance Data:
The information in the Premarket Notification on safety and effectiveness supports a finding of substantial equivalence to devices already in commercial distribution. Equivalence is demonstrated through intended use, materials and design.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" is arranged in a circular pattern around the symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Kevin VU, DDS C/O Mr. Glen Feye Accurate Consultants, Incorporated 1340 West Pennsylvania Avenue San Diego, California 92103
MAR 2 9 2007
Re: K070127
Trade/Device Name: Plaque Scraper-A Interproximal (between teeth) Plaque Remover Regulation Number: 21 CFR 872.4565 Regulation Name: Dental Hand Instrument Regulatory Class: I Product Code: EMN Dated: March 14, 2007 Received: March 18, 2007
Dear Mr. Feye:
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.
4
Page 2 - Mr. Feye
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); 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 (240) 276-0115. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Snyte y. Michael Omd.
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Section 4: Indications for Use Statements
Indications for Use
510(k) Number (if known): Unknown
Device Name: Plaque Scraper-A Interproximal (between teeth) Plaque Remover
Indications for Use:
The Plaque Scraper-A Interproximal (between teeth) Plaque Remover is an effective cleansing device which removes plaque and food between the teeth as part of a program for good oral hygiene to supplement the regular professional care required for oral health. This product is intended for personal oral hygiene use.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Suaser
Page 1 of
Anesthesiology, General Hospital ontrol. Dental Device
c(k) Number: K670127
Dr. Kevin Vu Section 510(k) Notification Plaque Scraper Indications For Use Revised_032307 (2).doc, December 20, 2006