(81 days)
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No
The device description and intended use clearly describe a chemical solution for dental preparation, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
The device is described as a cavity preparation solution used for cleaning and moistening tooth structure, and the manufacturer explicitly states it makes "no therapeutic claim" regarding its ingredients.
No
The document describes the device as being used to clean and moisten tooth structure to facilitate bonding or prior to sealing dentin tubules, which are all therapeutic or preparatory actions, not diagnostic.
No
The device description clearly states it is an "aqueous solution," indicating a liquid chemical product, 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 preparing teeth for various dental restorations (veneers, inlays, crowns, etc.). This is a direct treatment or preparation of the patient's tooth structure, not an analysis of a sample taken from the body.
- Device Description: The description focuses on the chemical composition and its function in cleaning and moistening tooth structure. This is a topical application for a physical effect on the tooth.
- Lack of Diagnostic Claims: The text explicitly states that Pulpdent makes no claim as to the antimicrobial effect of chlorhexidine gluconate or any therapeutic claim regarding the fluoride. This further reinforces that its purpose is not diagnostic.
- No mention of analyzing samples: IVDs are designed to analyze samples (blood, urine, tissue, etc.) to provide information about a patient's health status. This device is applied directly to the tooth.
Therefore, Pulpdent Cavity Preparation II is a dental material used in the preparation of teeth for restorative procedures, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Pulpdent Cavity Preparation II is used by the dental professional as one step in the preparation of teeth for veneers, inlays, crowns, onlays, amalgam and composite resin restorations. Pulpdent Cavity Preparation II. an aqueous solution of chlorhexidine gluconate, cleans and moistens tooth structure to facilitate bonding with adhesives that require moist surfaces. It can also be used prior to sealing dentin tubules. Recent studies have suggested that this cleansing step reduces micro leakage sensitivity in teeth undergoing treatment or restoration. Pulpdent makes no claim as to the antimicrobial effect of chlorhexidine gluconate. Pulpdent Cavity Preparation II with Fluoride combines all the features of Pulpdent Cavity Preparation II with the addition of sodium fluoride as a stabilizer. Pulpdent makes no therapeutic claim with regard to the addition of fluoride.
Product codes
LBH
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
teeth
Indicated Patient Age Range
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Intended User / Care Setting
dental professional
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 872.3260 Cavity varnish.
(a)
Identification. Cavity varnish is a device that consists of a compound intended to coat a prepared cavity of a tooth before insertion of restorative materials. The device is intended to prevent penetration of restorative materials, such as amalgam, into the dentinal tissue.(b)
Classification. Class II (special controls). The device, when it is an external cleaning solution, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.
0
Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's seal, which includes the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern. Inside the circle is a stylized representation of a human figure, consisting of three overlapping profiles facing to the right.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 9 2000
Mr. Kenneth J. Berk Director Pulpdent Corporation 80 Oakland Street Watertown, Massachusetts 02472
Re : K994181 Pulpdent Cavity Preparation II Trade Name: Requlatory Class: II Product Code: LBH Dated: December 7, 1999 Received: December 10, 1999
Dear Mr. Berk:
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, Druq, 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 aqainst 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. A substantially equivalent determination assumes compliance with the Good Manufacturinq Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in
1
Page 2 - Mr. Berk
Please note: this response to your the Federal Register. premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. 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 Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Patricia Cucentiffor
Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
INDICATIONS FOR USE STATEMENT
19994181
510 (k) Number (if known)
Device Name: PULPDENT CAVITY PREPARATION II
Indications for Use:
Pulpdent Cavity Preparation II is used by the dental professional as one step in the preparation of teeth for veneers, inlays, crowns, onlays, amalgam and composite resin restorations.
Pulpdent Cavity Preparation II. an aqueous solution of chlorhexidine gluconate, cleans and moistens tooth structure to facilitate bonding with adhesives that require moist surfaces. It can also be used prior to sealing dentin tubules. Recent studies have suggested that this cleansing step reduces micro leakage sensitivity in teeth undergoing treatment or restoration. Pulpdent makes no claim as to the antimicrobial effect of chlorhexidine gluconate.
Pulpdent Cavity Preparation II with Fluoride combines all the features of Pulpdent Cavity Preparation II with the addition of sodium fluoride as a stabilizer. Pulpdent makes no therapeutic claim with regard to the addition of fluoride.
Please do not write below this line. Continue on another page if needed.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
or
Over-The-Counter Use
Susan Rumm
(Division Sign-Off Division of Dental. Infection Con and General Hospital Devic 510(k) Number