(90 days)
Not Found
Not Found
No
The document describes a dental resin and does not mention any AI or ML components or functionalities.
Yes
The device is used as a penetrating composite sealer and bonding agent that "seals composite margins, penetrates and seals composite surface, reducing micro-leakage, wear and marginal breakdown." These functions are therapeutic as they directly treat or prevent issues related to dental restorations.
No.
The device is described as a light-cured, unfilled resin used as a penetrating composite sealer and bonding agent. Its function is to seal and bond, reducing micro-leakage, wear, and marginal breakdown, which are therapeutic and preventative actions, not diagnostic.
No
The device description clearly states it is a "light-cured, unfilled resin," which is a physical material, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that Pulpdent Glaze II is a dental material used as a penetrating composite sealer and bonding agent. It is applied directly to teeth and composite restorations.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections.
- Lack of Diagnostic Function: The description of Pulpdent Glaze II focuses on its physical properties and how it seals and bonds dental materials. There is no mention of it being used to analyze biological samples or provide diagnostic information.
Therefore, Pulpdent Glaze II is a dental device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Pulpdent Glaze II is a light-cured, unfilled resin that contains no Bisphenol A and is used as a penetrating composite sealer and bonding agent. Pulpdent Glaze II bonds to composite and etched enamel, seals composite margins, penetrates and seals composite surface, reducing micro-leakage, wear and marginal breakdown.
Product codes (comma separated list FDA assigned to the subject device)
76 KLE
Device Description
Pulpdent Glaze II is a light-cured, unfilled resin that contains no Bisphenol A and is used as a penetrating composite sealer and bonding agent. Pulpdent Glaze II bonds to composite and etched enamel, seals composite margins, penetrates and seals composite surface, reducing micro-leakage, wear and marginal breakdown.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
laboratory testing has shown that Pulpdent Glaze II is equivalent in physical and mechanical properties to the predicate products
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.
Pulpdent Resin Bonding Agent, Bisco Fortify, UltraDent PermaSeal
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
§ 872.3200 Resin tooth bonding agent.
(a)
Identification. A resin tooth bonding agent is a device material, such as methylmethacrylate, intended to be painted on the interior of a prepared cavity of a tooth to improve retention of a restoration, such as a filling.(b)
Classification. Class II.
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PULPDENT CORPORATION
MAY 1 6 2002
KO20514
EXHIBIT 2
SUMMARY OF SAFETY AND EFFECTIVENESS DATA
Kenneth J. Berk 80 Oakland Street PO Box 780 Watertown, MA 02472 USA
617-926-6666 Telephone: Fax: 617-926-6262 ken@pulpdent.com
DEVICE: Trade Name: PULPDENT GLAZE II Classification Name: Agent, Tooth Bonding, Resin FDA Product Code: 76 KLE, 21 CFR Part 872.3200
PREDICATE DEVICE:
Pulpdent Resin Bonding Agent Bisco Fortify UltraDent PermaSeal
DESCRIPTION AND INTENDED USE:
Pulpdent Glaze II is a light-cured, unfilled resin that contains no Bisphenol A and is used as a penetrating composite sealer and bonding agent. Pulpdent Glaze II bonds to composite and etched enamel, seals composite margins, penetrates and seals composite surface, reducing micro-leakage, wear and marginal breakdown.
COMPARISON WITH PREDICATE PRODUCTS:
PULPDENT GLAZE II substantially equivalent in design, composition, performance, intended use, safety and effectiveness to the predicate products listed above.
SAFETY AND EFFECTIVENESS:
PULPDENT GLAZE II is substantially equivalent in design, composition, performance, intended use, safety and effectiveness to the predicate products listed above. The predicate products have been found substantially equivalent under the 510(k) premarket notification process as Class II Dental Devices under CFR 872.3200. Though there is no ISO or ANSI/ADA standard applicable to Pulpdent Glaze II, laboratory testing has shown that Pulpdent Glaze II is equivalent in physical and mechanical properties to the predicate products,
According to the NH Technology Assessment Conference on Effects and Side-Effects of Dental Restorative Materials: "General usage of these materials over about 20 years indicates a high benefit-torisk ratio...both composites and glass ionomers are relatively trouble-free. There is no evidence of shortterm or long-term risk...There is no suspicion of any problems after virtually billions of procedures in the United States.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 1 6 2002
Mr. Kenneth J. Berk Director Pulpdent Corporation 80 Oakland Street Watertown, Massachusetts 02472
Re: K020514
Trade/Device Name: Pulpdent Glaze II Regulation Number: 21 CFR 872.3200 Regulation Name: Agent, Tooth Bonding, Resin Regulatory Class: II Product Code: KLE Dated: February 12, 2002 Received: February 15, 2002
Dear Mr. Berk:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
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
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Page 2 - Mr. Berk
and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice alle libang (21 CFF an in the quality systems (QS) regulation (21 CFR Part 820); and if requirements as between a product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 110(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 n you debire ope 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely,
Patricia Curente /for
Timothy A. Ulatowski 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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INDICATIONS FOR USE STATEMENT
510 (k) Number (if known)
PULPDENT GLAZE II Device Name
Indications for Use:
Pulpdent Glaze II is a light-cured, unfilled resin that contains no Bisphenol A and is r alpaon. One if to a light sealer and bonding agent. Pulpdent Glaze II bonds to composite and etched enamel, seals composite margins, penetrates and seals composite surface, reducing micro-leakage, wear and marginal breakdown.
Please do not write below this line. Continue on another page if needed.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Runne
Division Sign-Off
fon of Dental, Infection Control, and General Hospital Devices
510(k) Number K020514
Prescription Use レ (Per 21 CFR 801.109) - or
Over-The-Counter Use
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