(83 days)
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No
The device description and intended use describe a chemical solution for dental preparation, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
The document explicitly states, "Pulpdent makes no therapeutic claim with regard to the addition of fluoride." Additionally, its primary described functions are cleaning, moistening, and facilitating bonding, not treating a disease or condition. While it mentions reducing sensitivity, this is presented as a consequence of the cleansing step rather than a direct therapeutic claim.
No
The device is described as a solution for cleaning and moistening tooth structure to facilitate bonding, and it may reduce microleakage sensitivity. Its stated uses are for preparation of teeth for various dental restorations. There is no mention of it being used to identify or analyze a condition or disease.
No
The device description clearly states it is a "solution of glutaraldehyde and water," indicating it is a chemical substance, 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 dental restorations and facilitating bonding. This is a direct application to the patient's body (in vivo) for a therapeutic or restorative purpose.
- Device Description: The description focuses on the chemical composition and its function in cleaning and moistening tooth structure. It does not describe a device used to examine specimens derived from the human body for diagnostic purposes.
- Lack of Diagnostic Claims: There are no claims about diagnosing a disease, condition, or state of health. The mention of reducing micro leakage sensitivity is a performance characteristic related to the restoration process, not a diagnostic outcome.
- Anatomical Site: The anatomical site is "teeth," which are part of the living body, not a specimen taken from the body.
IVD devices are specifically designed to be used in vitro (outside the living body) to examine specimens (like blood, urine, tissue samples) to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This device does not fit that description.
N/A
Intended Use / Indications for Use
Pulpdent Cavity Preparation III 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 Preparations III, a solution of glutaraldehyde and water, 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. Sodium fluoride has been included in the formula for Pulpdent Cavity Preparation III to enhance the stability of the solution. Pulpdent makes no therapeutic claim with regard to the addition of fluoride.
Product codes
LBH
Device Description
Pulpdent Cavity Preparation III, a solution of glutaraldehyde and water, cleans and moistens tooth structure to facilitate bonding with adhesives that require moist surfaces. It can also be used prior to sealing dentin tubules. Sodium fluoride has been included in the formula for Pulpdent Cavity Preparation III to enhance the stability of the solution.
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 / Dentin
Indicated Patient Age Range
Not Found
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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc)
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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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles an abstract caduceus or a representation of human figures.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR - 2 2000
Mr. Kenneth J. Berk Director Pulpdent Corporation 80 Oakland Street Watertown, Massachusetts 02472
Re: K994180 Pulpdent Cavity Preparation III Trade Name: Regulatory 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, 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, qood 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 requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug 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 the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of
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Page 2 -- Mr. Berk
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 deberibed in your sieth, promalence 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 diaqnostic devices), please contact the Office of Compliance at (301) 594-4690. 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 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 (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
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
510 (k) Number (if known)
K 994480
PULPDENT CAVITY PREPARATION III Device Name
Indications for Use:
Pulpdent Cavity Preparation III 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 Preparations III, a solution of glutaraldehyde and water, 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. Sodium fluoride has been included in the formula for Pulpdent Cavity Preparation III to enhance the stability of the solution. 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
Sinem Rimmer
· Sign Off) of Dental, Infection Contro eneral Hospital Devices 10(k) Number_10994181