(74 days)
Not Found
Not Found
No
The description focuses on the material properties and intended use as a dental sealant, with no mention of AI or ML.
No.
The device is used to fill and seal pits and fissures in teeth (i.e., a sealant), which is a preventive measure rather than a therapeutic treatment for an existing condition.
No
Explanation: This device is a resin-based material used for filling and sealing pits and fissures in teeth (restorative/preventative), not for diagnosing conditions.
No
The device description clearly states it is a "fluoride-releasing, light-cured, resin-based material," which is a physical substance, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use is to "fill and seal the pits and fissures in teeth." This is a direct application to the patient's body for a therapeutic or preventative purpose, not for examining specimens derived from the human body to provide information for diagnosis, monitoring, or compatibility testing.
- Device Description: The description reinforces the intended use as a material applied to teeth.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), providing diagnostic information, or being used in a laboratory setting for testing purposes.
Therefore, this device falls under the category of a dental material used for direct patient treatment, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Pulpdent Dentition Integrating Material is a fluoride-releasing, light-cured, resin-based material that bonds tightly to dentition and is used to fill and seal the pits and fissures in teeth.
Product codes
76 EBC
Device Description
Dentition Integrating Material is a fluoride-releasing, light-cured, resin-based material that bonds tightly to dentition and is used to fill and seal the pits and fissures in teeth.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
teeth
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Pulpdent Flows-Rite, Pulpdent Seal-Rite Pit and Fissure Sealant, Pulpdent Seal-Rite Low Viscosity Pit and Fissure Sealant, Pulodent Seal-Rite UDMA, Kuraray Clear-Fil, Kerr OptiBond Solo Plus 3
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.3765 Pit and fissure sealant and conditioner.
(a)
Identification. A pit and fissure sealant and conditioner is a device composed of resin, such as polymethylmethacrylate, intended for use primarily in young children to seal pit and fissure depressions (faults in the enamel) in the biting surfaces of teeth to prevent cavities.(b)
Classification. Class II.
0
APR 1 2 2002
PULPDENT CORPORATION
510 k Promarket Notification K 020287 Pulpdent Dentition Integrating Material
EXHIBIT 2
SUMMARY OF SAFETY AND EFFECTIVENESS DATA
Kenneth J. Berk 80 Oakland Street PO Box 780 Watertown, MA 02472 USA
Telephone: 617-926-6666 Fax: 617-926-6262 ken@pulpdent.com
DEVICE:
Trade Name: PULPDENT DENTITION INTEGRATING MATERIAL Classification Name: Sealant, Pit and Fissure, and Conditioner FDA Product Code: 76 EBC, 21 CFR Part 872.3765
PREDICATE DEVICE:
Pulpdent Flows-Rite Pulpdent Seal-Rite Pit and Fissure Sealant Pulpdent Seal-Rite Low Viscosity Pit and Fissure Sealant Pulodent Seal-Rite UDMA Kuraray Clear-Fil Kerr OptiBond Solo Plus 3
DESCRIPTION AND INTENDED USE:
Dentition Integrating Material is a fluoride-releasing, light-cured, resin-based material that bonds tightly to dentition and is used to fill and seal the pits and fissures in teeth.
COMPARISON WITH PREDICATE PRODUCTS:
PULPDENT DENTITION INTEGRATING MATERIAL Is substantially equivalent in design, composition, r of DENT DENTITUTY in a safety and effectiveness to the predicate products listed above.
SAFETY AND EFFECTIVENESS:
PULPDENT DENTITION INTEGRATING MATERIAL is substantially equivalent in design, composition, performance, intended use, safety and effectiveness to the predicate products listed above . The periormance, intended bost, but strantially equivalent under the 510(k) premarket notification process as Class II Dental Devices under CFR 872.3690, 872.3765 or 872.3200. The chemical process as Class II Dentifican Integrating Material are used in the predicate products. Though there is no Ingledients dsed in Demittion Integraing Material, laboratory testing Material, laboratory testing has shown that Dentifian Integrating Material is equivalent in physical and mechanical properties to the predicale products.
According to the NIH Technology Assessment Conference on Effects and Side-Effects of Dential Accurative Materials: "General usage of these materials over about 20 years indicates a high benefit-torisk rationals. " Ocheral assge of these are relatively trouble free. There is no evidence of shorthis fratu... Dour composites and grass londiners are relatively billions of procedures in the United States.
1
Image /page/1/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. Inside the circle is an abstract image of an eagle's head.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 1 2 2002
Mr. Kenneth J. Berk Director Pulpdent Corporation 80 Oakland Street Watertown, Massachusetts 02472
Re: K020287
Trade/Device Name: Pulpdent Dentition Integrating Material Regulation Number: 872.3765 Regulation Name: Pit and Fissure Sealant and Conditioner Regulatory Class: II Product Code: EBC Dated: January 23, 2002 Received: January 28, 2002
Dear Mr. Berk:
We have reviewed your Section 510(k) premarket notification of intent to market the device wo nave 10 row and have determined the device is substantially equivalent (for the recenced above and in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Interstate commerce prior to hay are 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 approvisions of the Act. The general controls provisions of the Act include controls providents of an 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 If your device is classified (see a siditional controls. Existing major regulations affecting (I MA), it may of subject to the Code of Federal Regulations, Title 21, Parts 800 to 898. In your device ear or roublish 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 mount that I Dr may Federal statutes and regulations administered by other Federal agencies.
2
Page 2 - Mr. Berk
You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic 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 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 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 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
3
K.020.28"
Page 1 of 1
INDICATIONS FOR USE STATEMENT
K 020287 510 (k) Number
PULPDENT DENTITION INTEGRATING MATERIAL Device Name
Indications for Use:
Pulpdent Dentition Integrating Material is a fluoride-releasing, light-cured, resin-based material that bonds tightly to dentition and is used to fill and seal the pits and fissures in teeth.
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 Runo
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Revice 510(k) Number ________________________________________________________________________________________________________________________________________________________________