(89 days)
Not Found
No
The 510(k) summary describes a chemical formulation (varnish) for dental use and does not mention any software, algorithms, or AI/ML capabilities.
No.
The device acts as a protective coating and barrier to alleviate symptoms like sensitivity and thermal shock, but it does not treat or cure a disease or condition. It is a desensitizing and sealing agent rather than a therapeutic treatment for the underlying issue.
No
The device is described as a desensitizing cavity varnish and dentinal tubule sealer used to protect dentin and pulp and reduce sensitivity, which are therapeutic functions, not diagnostic ones.
No
The device description clearly states it is a mixture of resins and strontium chloride in an organic solvent, which are physical components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a product applied directly to the patient's teeth (dentin, cementum, enamel) to treat sensitivity, seal tubules, and act as a protective coating. This is a direct therapeutic or protective application within the body, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The description details the chemical composition of a varnish applied to the tooth surface. This aligns with a topical dental product, not a diagnostic reagent or instrument used for testing biological samples.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring specific substances in samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
The device is clearly intended for direct application to the patient's teeth by a dental professional for therapeutic and protective purposes.
N/A
Intended Use / Indications for Use
Pulpdent VARNISH I, II, III, and IV are desensitizing cavity varnishes and dentinal tubule sealers. They are indicated for exposed sensitive dentin or cementum after scaling, prophylaxis, cavity preparation and prior to any cementation and pin or post seating. Pulpdent VARNISH forms a hard protective coating which protects dentin and pulp, reduces acid diffusion from cements, minimizes marginal leaks and acts as a thermal insulator. This coating controls dentinal fluid flow by sealing the dentinal tubules and producing a physiologic barrier. Pulpdent VARNISH is used by the dental professional to control thermal shock and sensitivity in teeth undergoing treatment or restoration. It can be applied to all prepared cavities, to dentin and enamel, with or without the smear layer removed. Pulpdent VARNISH can be used under veneers, inlays, crowns, onlays, amalgams and composite resins and to treat cervical or root sensitivity.
Product codes
GBH
Device Description
Pulpdent VARNISH I, II, III, and IV are desensitizing cavity varnishes and dentinal tubule sealers. Pulpdent VARNISH is a mixture of either copal resin or polyamide resin and strontium chloride in organic solvent. Formulas for Pulpdent Vamish III and IV also contain the surfactant cetyl pyridinium chloride.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Dentin, cementum, enamel (teeth)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Dental professional
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)
According to the scientific and clinical literature, use of cavity varnishes made from the materials present in Pulpdent Varnish have been effective and safe over about twenty years of experience. There is no evidence of short or long term risk or suspicion of any problems after literally billions of procedures in the United States.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Pulpdent VARNISH I, II, III, IV, Pulpdent Polyamide Dentin Liner, Pulpdent Copal Varnish, Cetylite Zarosen, Cooley & Cooley Copalite Varnish
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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
PULPDENT CORPORATION
510 k PREMARKET NOTIFICATION: CAVITY VARNISH
EXHIBIT 2
FEB | 8 1998
RESPONSE TO SMDA OF 1990
SUMMARY OF SAFETY AND EFFECTIVENESS DATA
Kenneth J. Berk 80 Oakland Street PO Box 780 Watertown, MA 02272-0780 USA TELEPHONE: (617) 926-6666 (617) 926-6262 FAX:
DEVICE NAME:
PREDICATE DEVICES:
Pulpdent VARNISH I, II. III. IV
Pulpdent Polyamide Dentin Liner Pulpdent Copal Varnish Cetylite Zarosen Cooley & Cooley Copalite Varnish
DESCRIPTION AND INTENDED USE:
Pulpdent VARNISH I, II, III, IV are desensitizing cavity varnishes and dentinal tubule sealers, They are indicated for exposed sensitive dentin or cementum after scaling, prophylaxis, cavity preparation and prior to any cementation and pin or post seating. Pulpdent VARNISH forms a hard protective coating which protects dentin and pulp, reduces acid diffusion from cements. minimizes marginal leaks and acts as a thermal insulator. This coating controls dentinal fluid flow by sealing the dentinal tubules and producing a physiologic barrier. It can be applied to all prepared cavities, to dentin and enamel, with or without the smear layer removed.
Pulpdent VARNISH is used by the dental professional to control thermal shock and sensitivity in teeth undergoing treatment or restoration. It can be used under veneers, inlays, crowns, onlays, amalgams and composite resins and to treat cervical or root sensitivity. Pulpdent VARNISH is a mixture of either copal resin or polyamide resin and strontium chloride in organic solvent. Formulas for Pulpdent Vamish III and IV also contain the surfactant cetyl pyridinium chlonde.
COMPARISON WITH PREDICATE PRODUCTS:
Pulpdent VARNISH is substantially equivalent in composition and intended use to the predicate products. Please see Exhibit 4 for the entire comparison.
SAFETY AND EFFECTIVENESS:
According to the scientific and clinical literature, use of cavity varnishes made from the materials present in Pulpdent Varnish have been effective and safe over about twenty years of experience. There is no evidence of short or long term risk or suspicion of any problems after literally billions of procedures in the United States. Please see Exhibit 8 for representative references.
1
Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three human profiles incorporated into its design. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 8 1998
Mr. Kenneth J. Berk Director Pulpdent Corporation 80 Oakland Street 02272-0780 Watertown, Massachusetts
Re : K974398 Trade Name: Pulpdent Cavity Varnish Regulatory Class: II Product Code: ГВН Dated: November 17, 1997 Received: November 21, 1997
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, 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 requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਸ 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 requlation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. 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
2
Page 2 - Mr. Berk
through 542 of the Act for devices under the Electronic Product Radiation Control 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 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. 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
Timot A. Ulatowski Directdr Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Page 1 ol 1
5 1 O(k) Number (il known):
Device Name: PULPDENT CAVITY VARNISH
Indications I-or Use:
Pulpdent VARNISH I, II, III, and IV are desensitizing cavity varnishes and dentinal tubule sealers. They are indicated for exposed sensitive dentin or cementum after scaling, prophylaxis, cavity preparation and prior to any cementation and pin or post seating. Pulpdent VARNISH forms a hard protective coating which protects dentin and pulp, reduces acid diffusion from cements, minimizes marginal leaks and acts as a thermal insulator. This coating controls dentinal fluid flow by sealing the dentinal tubules and producing a physiologic barrier. Pulpdent VARNISH is used by the dental professional to control thermal shock and sensitivity in teeth undergoing treatment or restoration. It can be applied to all prepared cavities, to dentin and enamel, with or without the smear layer removed. Pulpdent VARNISH can be used under veneers, inlays, crowns, onlays, amalgams and composite resins and to treat cervical or root sensitivity. Pulpdent VARNISH I, II, III and IV are mixtures of either copal resin or polyamide resin and strontium chloride in organic solvent. The formulas for Varnish III and IV also contain the surfactant, cetyl pyridinium chloride.
(PLEASE DO NOT WRITE:BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED!
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Susan Purser | |
|---|---|
| (Division Sign-Off) | |
| Division of Dental, Infection Control, and General Hospital Devices | |
| 510(k) Number | K974138 |
| Prescription Use
| (Per 21 CFR 801.109) | OR | Over-The-Counter Use |
|---|---|---|
| ------------------------------------------ | ---- | ---------------------- |
(Optional Format 1-2-96)