CARIES STAIN

K973200 · Parkell, Inc. · LFC · Nov 6, 1997 · Dental

Device Facts

• Record ID: K973200
• Device Name: CARIES STAIN
• Applicant: Parkell, Inc.
• Product Code: LFC · Dental
• Decision Date: Nov 6, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.1740
• Device Class: Class 2

Intended Use

For use as a color-indicator of caries demineralized dentin. The water-soluble dye differentiates between dentin infected by caries and uninfected demineralized dentin and serves as a guide for the dentist-user in the removal of caries during restoration.

Device Story

Caries Stain is a water-soluble dye solution applied by dentists during restorative procedures. The dye selectively stains infected, carious dentin, providing a visual color contrast to healthy or remineralizable dentin. This allows the clinician to distinguish between tissue requiring removal and tissue that should be preserved. The device acts as a visual guide to facilitate conservative caries removal, helping the dentist maintain maximum vital tooth structure during cavity preparation.

Clinical Evidence

No clinical data provided; device relies on established chemical properties of caries-staining dyes used in dentistry.

Technological Characteristics

Water-soluble dye solution in solvent. Applied topically to dentin. Functions via selective staining of infected dentin. Non-electronic, non-mechanical, chemical diagnostic aid.

Indications for Use

Indicated for use by dentists as a color-indicator to differentiate between infected carious dentin and remineralizable dentin to guide conservative caries removal during dental restoration procedures.

Regulatory Classification

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.

Predicate Devices

• KAR-D-TEK
• CARIES DETECTOR
• SEEK
• CARIES FINDER
• TEAM CARIES INDICATOR
• PULPDENT SNOOP

Submission Summary (Full Text)

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## 510(k) SUMMARY

NOV - 6 1997

| Submitter: | Parkell Products Inc.<br>155 Schmitt Blvd.<br>Box 376<br>Farmingdale, NY 11735<br>TEL: [phone]<br>FAX: [phone] |
|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Nelson J. Gendusa, DDS<br>Director of Research<br>Parkell<br>155 Schmitt Blvd.<br>Box 376<br>Farmingdale, NY 11735 |
| Submission Date: | 14 August, 1997 |
| Trade Name: | CARIES STAIN |
| Common Name: | Caries Indicator/Detector |
| Classification Name: | Caries Detection Device |
| Equivalence: | KAR-D-TEK; CARIES DETECTOR; SEEK; CARIES FINDER;<br>TEAM CARIES INDICATOR; PULPDENT SNOOP |
| Description/Intended Use: | CARIES STAIN may be described as a water-soluble solution of<br>dye in solvent that selectively stains carious, infected dentin. It<br>differentiates between non-remineralizable and remineralizable<br>dentin to serve as a guide for conservative caries removal while<br>maintaining as much vital tooth structure as possible. |

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Nelson J. Gendusa, DDS Director of Research Parkell Products, Incorporated 155 Schmitt Boulevard Farmingdale, New York 11735

NOV - 6 1997

Re: K973200 Trade Name: Caries Stain Regulatory Class: II Product Code: LFC Dated: August 21, 1997 Received: Auqust 26, 1997

Dear Dr. Gendusa:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਉ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531

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Page 2 - Dr. Gendusa

through 542 of the Act for devices under the Electronic chrough 542 or the not il provisions, or other Federal laws or requlations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA acbeing of substantial equivalence of your device to a legally marketed predicate device results in a classification for your marketed predication with your device to proceed to the market.

If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact ene promotion and [phone]. Also, please note ene regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely Yours,

Timothy J. Ulatowski

Timb Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

. Enclosure

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510(k) Number (if known):

Device Name:

CARIES STAIN

Indications For Use:

For use as a color-indicator of caries demineralized dentin. The water-soluble dye differentiates between dentin infected by caries water-soluble dye differentates occa a guide for the dentist-user in and unancecco demir and be? (es as a games restoration.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Rumsis

(Division Sign-Off Division of Dental and General Ho 510(k) Number

Prescription Use رسم (Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Format 1-2-96)