(225 days)
K 811154
Not Found
No
The device description and performance studies focus on the physical properties and delivery mechanism of a custom-fit tray, with no mention of AI or ML technologies.
Yes
The device is intended to deliver solutions deeper into gingival crevices or periodontal pockets, which suggests a therapeutic action to treat or prevent dental conditions.
No
Explanation: The device is intended for delivering solutions to gingival crevices, which is a therapeutic rather than a diagnostic function. It does not identify a disease, condition, or state of health.
No
The device is a physical, custom-fit tray made from impressions of a patient's mouth, indicating it is a hardware device, not software.
Based on the provided information, the Perio Protect Tray is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Perio Protect Tray's Function: The Perio Protect Tray is a delivery system. Its purpose is to place solutions into the gingival crevices or periodontal pockets in the patient's mouth. It does not analyze or test any biological specimens outside the body.
- Intended Use: The intended use clearly states it's for placing solutions into the mouth, not for analyzing samples.
- Device Description: The description focuses on the physical tray and its custom fit, not on any analytical components.
- Performance Studies: The performance studies described focus on the delivery of the solution (dye presence) and the physical properties of the tray (removal force), not on the analysis of biological samples.
Therefore, the Perio Protect Tray is a medical device, but it falls under a different classification than an IVD. It's a device used for treatment or delivery of substances within the body.
N/A
Intended Use / Indications for Use
The Perio Protect Tray is intended to be used to place solutions of the clinician's choice into gingival crevices or periodontal pockets. The design of the Perio Protect Tray permits placement of solutions deeper into the crevice/pocket than is possible with traditional fluoride trays.
The choice of solution, the frequency of use, and the time the tray is to be in place are a part of the practice of dentistry, and are to be determined by the clinician.
Product codes
KMT
Device Description
The Perio Protect Tray is a custom fit tray made from impressions of the patents mouth taken by a licensed dentist. The patient impressions are then sent to a specialized dental laboratory which makes a custom fit tray for the individual patient.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
gingival crevices or periodontal pockets, gingival sulcus, teeth and surrounding tissues
Indicated Patient Age Range
Not Found
Intended User / Care Setting
licensed dentist, clinician
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
- A. Data demonstrating different solutions used in the clinician's practice of dentistry are delivered to the teeth and surrounding tissues by use of the Perio Protect Tray.
Sodium Fluorescein dye was mixed in an aqueous solution and applied to the Perio Protect Tray with one drop of Peroxyl (hydrogen peroxide) gel. Sodium Fluorescein is a phosphorescent dye that can be illuminated under a black light.
The patients wore the trays 10 – 15 minutes in the morning and evening for one day. The patients were examined 24 hours later and a black light was used to illuminate the region around the teeth. Sodium fluorescein dye was observed in the gingival sulcus.
- B. The force necessary to remove the Perio Protect Tray was also tested.
Trays were also placed in the patient's mouth. A gram gauge was used to remove the tray from the patient's mouth. Each of these tests was repeated 10 times and an average of the force necessary to remove the tray was computed.
Key Metrics
Not Found
Predicate Device(s)
K 811154
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.6870 Disposable fluoride tray.
(a)
Identification. A disposable fluoride tray is a device made of styrofoam intended to apply fluoride topically to the teeth. To use the tray, the patient bites down on the tray which has been filled with a fluoride solution.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9. If the device is not labeled or otherwise represented as sterile, it is exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.
0
510(k) Summary
for
Perio Protect Tray
1. DATE PREPARED
January 14, 2004
2. SPONSOR INFORMATION
Main Office
Perio Protect LLC 3929 Bayless Avenue St. Louis, MO 63125
Mailing Address
Perio Protect LLC 3929 Bayless Avenue St. Louis, MO 63125
Contact Person: Duane C. Keller, D.M.D.
(314) 638-4190 (telephone) (314) 638-3900 (facsimile)
Outside Regulatory Counsel
Gray Cary Ware & Freidenrich દામ 1625 Massachusetts Ave., NW - Ste 300 Washington, DC 20036
(202) 238-7749 (telephone) (202) 238-7701 (facsimile)
Contact Person: David L. Rosen, R.Ph., J.D.
1
3. DEVICE NAME
Proprietary Name: Perio Protect Tray Common/Usual Name: Dental Tray Classification Name: Disposable Fluoride Tray (per 21 C.F.R § 872.6870 (2002))
4. DEVICE DESCRIPTION AND INTENDED USE
The Perio Protect Tray is a custom fit tray made from impressions of the patents mouth taken by a licensed dentist. The patient impressions are then sent to a specialized dental laboratory which makes a custom fit tray for the individual patient.
The Perio Protect Tray is intended to be used to place solutions of the clinician's choice into gingival crevices or periodontal pockets. The design of the Perio Protect Tray permits placement of solutions deeper into the crevice/pocket than is possible with traditional fluoride trays.
The choice of solution, the frequency of use, and the time the tray is to be in place are a part of the practice of dentistry, and are to be determined by the clinician.
5. PREDICATE DEVICE
Hoyt Laboratories
Disposable Fluoride Tray - K 811154
Such products are now Class I Exempt per 21 C.F.R § 872.6870 (2002)
2
Substantial Equivalence Comparison
| | Delivery of Oral Irrigation Materials | Indication for Use | Design | Materials | Anatomic
Sites |
|--------------------------------------------------------|---------------------------------------|------------------------------|-----------|-------------|-------------------|
| rio Protect Tray
Fluoride Tray
Hoyt Laboratories | Site specific | Irrigation / solutions | Custom | Elastomeric | Teeth / gingiva |
| 11154 | General area specific | Topical fluoride application | Preformed | Foam | Teeth |
6. DEVICE TESTING
PERFORMANCE DATA
- A. Data demonstrating different solutions used in the clinician's practice of dentistry are delivered to the teeth and surrounding tissues by use of the Perio Protect Tray.
Sodium Fluorescein dye was mixed in an aqueous solution and applied to the Perio Protect Tray with one drop of Peroxyl (hydrogen peroxide) gel. Sodium Fluorescein is a phosphorescent dye that can be illuminated under a black light.
The patients wore the trays 10 – 15 minutes in the morning and evening for one day. The patients were examined 24 hours later and a black light was used to illuminate the region around the teeth. Sodium fluorescein dye was observed in the gingival sulcus.
- B. The force necessary to remove the Perio Protect Tray was also tested.
Trays were also placed in the patient's mouth. A gram gauge was used to remove the tray from the patient's mouth. Each of these tests was repeated 10 times and an average of the force necessary to remove the tray was computed.
3
Image /page/3/Picture/0 description: The image shows two drawings of teeth. The top drawing shows a set of teeth labeled 44. The bottom drawing shows a set of teeth labeled 32 and 34.
.
4
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles a bird or a person with outstretched arms, composed of three curved lines.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 2 3 2004
Perio Protect LLC C/O Dr. David L. Rosen Gray Cary Ware & Freidenrich LLP 1625 Massachusetts Avenue NW, Suite 300 Washington, D.C. 20036-2247
Re: K031809/S1
Trade/Device Name: Perio Protect Tray Regulation Number: 21 CFR 872.6870 Regulation Name: Disposable Flouride Tray Regulatory Class: I Product Code: KMT Dated: October 27, 2003 Received: October 30, 2003
Dear Dr. Rosen:
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.
5
Page 2 - Dr. Rosen
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 (OS) 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. 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
Sincerely vours,
Chis
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
6
510(k) Number (if known):
Device Name:
Indications for Use:
Trade Name: Perio Protect Tray
The Perio Protect Tray is intended to be used to place solutions of the clinician's choice into gingival crevices or periodontal pockets. The design of the Perio Protect Tray permits placement of solutions deeper into the crevice/pocket than is possible with traditional fluoride trays.
The choice of solution, the frequency of use, and the time the tray is to be in place are a part of the practice of dentistry, and are to be determined by the clinician.
PLEASE DO NOT WRITE BELOW THIS LINE (Continue on Another Page If Needed)
Concurrence of CDRH, Office of Evaluation (ODE)
(Division Sign-Off)
Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices
510(k) Number K031809
Prescription Use
(Per 21 CFR 801.109)
Over-The-Counter Use