(164 days)
Not Found
No
The device description explicitly states it is a red dye agent and does not involve chemical reactions or power-assisted devices. There is no mention of AI, ML, image processing, or data sets for training or testing.
No.
The device is a diagnostic tool used to detect carious dentin, not to treat or cure a disease.
Yes
The device is indicated for use "to detect carious dentin" and is described as a "caries detector," which directly relates to diagnosing a condition.
No
The device description explicitly states that DiscovRED™ is a "red dye agent" and describes its application and use as a chemical stain, not a software program.
Based on the provided information, no, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- DiscovRED™'s Function: DiscovRED™ is a dye applied directly to the tooth in vivo (within the living body) to stain carious dentin. It is used as a visual aid during a dental procedure to guide the removal of diseased tissue.
- Lack of Specimen Examination: The device does not involve the collection or examination of a specimen taken from the body. The dye is applied directly to the anatomical site (the tooth).
While it is a diagnostic aid in the sense that it helps the dentist identify diseased tissue, its mechanism of action and application do not fit the definition of an In Vitro Diagnostic device. It is a topical agent used in vivo to facilitate a diagnostic and treatment procedure.
N/A
Intended Use / Indications for Use
"DiscovRED™ is indicated for use to detect carious dentine."
Product codes (comma separated list FDA assigned to the subject device)
LFC
Device Description
The product, DiscovRED™, is classified into the Caries Detection Device category of CFR 21, Section 872.1740.
DiscovRED™, as well as the Predicate Device, Caries Detector, is a red dye agent that when applied to the suspected carious areas of the tooth stains the carious dentine.
DiscovRED™ is a caries detector. Both devices have a two year shelf-life.
DiscovRED™ is for Prescription Use only and not over-the-counter use.
The method of operation and placement of DiscovRED™ is similar to that of the Predicate Device, Caries Detector. A drop of the detector is applied to the carious dentine, rinsed with water and air dispersed. The stained carious tissue is then removed with a low speed rotary bur. The process may be repeated until there are no more stainable tissues in the cavity.
DiscovRED™ and the Predicate Device do not involve chemical reactions.
DiscovRED™ and the Predicate Device do not use any power-assisted devices such as optical light emitting or electrical energy forms.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Tooth
Indicated Patient Age Range
Not Found
Intended User / Care Setting
dental professional, i.e. dentist
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
§ 872.1740 Caries detection device.
(a)
Identification. The caries detection device is a device intended to show the existence of decay in a patient's tooth by use of electrical current.(b)
Classification. Class II.
0
PHOENIX DENTAL IN
"Better Dentistry through Chemistry"
11224 Phoenix Drive
Fenton, MI 48430
MAKERS OF SUPER SEAL®
Phone: 810.750.2328 or Toll-free: 877.463.9905 Fax: 810.750.7495 www.phoenixdental.com
| Submitting Applicant Company | |
|---|---|
| 1) Name | Phoenix Dental, Inc. |
| 2) Address | 3452 West Thompson Road |
| Fenton, Michigan, 48430 | |
| 3) Contact Person | Jeffrey S. Cox, President/CEO |
| Telephone: 877-463-9905 | |
| Facsimile: 810-750-7495 | |
| 4) Establishment Registration Number | 1836322 |
| 5) Date | September 22, 2010 |
| MAR 11 20 |
510(k) SUMMARY
| 2. Name of Device | |
|---|---|
| 1) Proprietary Name | DiscovRED™ |
| 2) Common / Usual Name | Caries Detector |
| 3) Classification Name | Caries Detection Device |
-
- Legally marketed device to which the submitter claims equivalence Predicate Device Caries Detector by Kuraray Medical Inc. (K012733) 1) Class = 2) Regulation Number 872.1740 3) Panel Dental 4) Classification Product Number LFC 5) Prescription Use Only Yes
-
- Description of device subject to this premarket notification submission The product, DiscovRED™, is classified into the Caries Detection Device category of CFR 21, Section 872.1740.
DiscovRED™, as well as the Predicate Device, Caries Detector, is a red dye agent that when applied to the suspected carious areas of the tooth stains the carious dentine.
DiscovRED™ is a caries detector. Both devices have a two year shelf-life.
DiscovRED™ is for Prescription Use only and not over-the-counter use.
The method of operation and placement of DiscovRED™ is similar to that of the Predicate Device, Caries Detector. A drop of the detector is applied to the carious dentine, rinsed with water and air dispersed. The stained carious tissue is then removed with a low speed rotary bur. The process may be repeated until there are no more stainable tissues in the cavity.
DiscovRED™ and the Predicate Device do not involve chemical reactions.
DiscovRED™ and the Predicate Device do not use any power-assisted devices such as optical light emitting or electrical energy forms.
1
510(k) Summary (continued)
5. Statement of the intended use
The intended use of the device, DiscovRED™, is as follows:
"DiscovRED™ is indicated for use to detect carious dentine."
DiscovRED™ has the same intended clinical use as the Predicate Device, Caries Detector, of detecting carious dentine when a dental patient presents with an area of suspected tooth decay.
-
- Statement of technological characteristics and safety DiscovRED™ has similar technological characteristics as the Predicate Device, Caries Detector.
Both devices are composed of glycol based chemistries in combination with a red dye colorant that is used to stain/detect carious dentine of the tooth.
- Statement of technological characteristics and safety DiscovRED™ has similar technological characteristics as the Predicate Device, Caries Detector.
The safety of DiscovRED™ is very similar to the commercially available Predicate Device, Caries Detector. Both devices must be handled by a dental professional, i.e. dentist, according to their Instructions for Use and Material Safety Data Sheets.
The two devices' main ingredients, polyethylene glycol for DiscovRED™ and propylene glycol for Caries Detector, have similar potential health effects. Repeated or prolonged exposure of either product is not known to aggravate any medical condition.
The first aid measures of both devices are similar in that for any skin contact, wash the area with soap and water, and for eye contact, flush with water and seek medical attention. For inhalation, remove to fresh air, and for ingestion, rinse the mouth with water and spit into sink.
Toxicological data on the primary ingredients of both DiscovRED™ and Caries Detector are also similar; however, LDso values for oral toxicity indicate that the primary ingredient in Caries Detector, propylene glycol, is more toxic (lower values) than the primary ingredient, polyethylene glycol, in DiscovRED™. Therefore, one may summize that DiscovRED™ is less toxic than the commercially available Predicate Device, Caries Detector. The small amount, less than one drop, used on a micro sponge in a single application of the device is unlikely a sufficient amount to cause harmful affects to a human. The Instructions for Use and MSDS information should be followed.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular arrangement of the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" surrounding a stylized eagle symbol. The eagle is depicted with its wings spread, and its body is formed by three curved lines.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Mr. Jeffrev S. Cox President/ Chief Executive Officer Phoenix Dental. Incorporated 3452 West Thompson Road Fenton, Michigan 48430
- Re: K102821
MAR 1 1 2011
Trade/Device Name: DiscovREDTM Regulation Number: 21 CFR 872.1740 Regulation Name: Caries Detection Device Regulatory Class: II Product Code: LFC Dated: March 4, 2011 Received: March 7, 2011
Dear Mr. Cox:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
3
Page 2- Mr. Cox
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm 115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Anthony D. Watson
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number: K102821
Device Name: DiscovRED™
Indications for Use:
DiscovRED™ is indicated for use to detect carious dentin.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Per 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (Per 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Rump
(Division Sign-Off Division of Anesthesiology, General Hospital Infection Control, Dental Devices
Page 1 of ____________________________________________________________________________________________________________________________________________________________________
510(k) Number:
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