(42 days)
K 974014
K 974014, K 926074, K 931710
No
The device description and intended use clearly describe a chemical bonding agent kit, with no mention of software, data processing, or AI/ML terms.
No
The device is a bonding agent used to adhere materials to anatomical structures, not to treat, mitigate, or prevent a disease or condition.
No
This device is described as a bonding resin and catalyst used by dentists to bond to various dental materials. Its stated purpose is for adhesion, not for diagnosing medical conditions or diseases.
No
The device description clearly states it is a "kit containing DenTASTIC UNO, a single-component light cure dental primer / bonding resin and a Dual Cure Catalyst," indicating it is a physical product, 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 clearly states that the device is used by a dentist to bond materials (dentin, enamel, metals, resins) in the mouth. This is a direct application within the body for a therapeutic or restorative purpose.
- Device Description: The description reinforces the intended use by describing a dental bonding kit used by a dentist.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
IVD devices are used outside the body to analyze samples for diagnostic purposes. This device is used inside the body for a dental procedure.
N/A
Intended Use / Indications for Use
PULPDENT DENTASTIC UNO-DUO is a kit containing DenTASTIC UNO, a singlecomponent light cure dental primer / bonding resin [K 974014] and a Dual Cure Catalyst [K 926074, K 931710]. PULPDENT UNO-DUO is used by the dentist to bond to dentin, enamel, metals and resins in those situations in which a dual cure product is indicated.
Product codes (comma separated list FDA assigned to the subject device)
KLE
Device Description
PULPDENT UNO-DUO is a kit containing DenTASTIC UNO, a single-component light cure dental primer / bonding resin [K 974014] and a Dual Cure Catalyst [K 926074, K 931710]. PULPDENT UNC-DUO is used by the dentist to bond to dentin, enamel, metals and resins in those situations in which helshe prefers a self-cure or dual cure product.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
dentin, enamel
Indicated Patient Age Range
Not Found
Intended User / Care Setting
dentist
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): 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 UNO PULPDENT DENTASTIC Dentsply / Caulk PRIME & BOND NT DUAL CURE
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.
K 974014, K 926074, K 931710
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.
0
Image /page/0/Picture/2 description: The image shows a sequence of characters, seemingly handwritten or stylized. The characters are 'K93683'. The characters are bold and black, set against a white background. A horizontal line is above the characters.
DEC 1 3 1999
EXHIBIT 2
RESPONSE TO SMDA OF 1990
SUMMARY OF SAFETY AND EFFECTIVENESS DATA
Kenneth J. Berk 80 Oakland Street PO Box 780 Watertown, MA 02472 USA Telephone: Fax:
617-926-6666 617-926-6262
DEVICE NAME: PULPDENT UNO-DUO
PREDICATE DEVICES:
PULPDENT UNO PULPDENT DENTASTIC Dentsply / Caulk PRIME & BOND NT DUAL CURE
DESCRIPTION AND INTENDED USE:
PULPDENT UNO-DUO is a kit containing DenTASTIC UNO, a single-component light cure dental primer / bonding resin [K 974014] and a Dual Cure Catalyst [K 926074, K 931710]. PULPDENT UNC-DUO is used by the dentist to bond to dentin, enamel, metals and resins in those situations in which helshe prefers a self-cure or dual cure product.
DenTASTIC UNO-DUO is based on the same technology from the American Dental Association (ADA) Health Foundation as Pulpdent DenTASTIC (Parts A, B and C) and Pulpdent DenTASTIC UNO. The formula for this product is based on research done by the ADA Health Foundation. Pulpdent manufactures DenTASTIC and DenTASTIC UNO under license from the ADA Health Foundation.
COMPARISON WITH PREDICATE PRODUCTS:
DenTASTIC UNC-DUO is substantially equivalent in composition and intended use to the abovementioned predicate product. Please see Exhibit 5 for the entire comparison.
SAFETY AND EFFECTIVENESS:
All of the components used in DenTASTIC UNO-DUO have been used in legally marketed predicate dental devices.
According to the NIH 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...[they] are relatively trouble-free. There is no evidence of short-term or long-term risk... There is no suspicion of any problems after virtually billions of procedures in the United States.
The effectiveness of this type of adhesive system is supported by research performed at the ADA Health Foundation, by research papers, and by evaluation by the editors of Reality, 1999. In addition, the predicate product listed above has been given 510 (k) Premarket approval as Class II Dental Devices under CFR 872.3690 Please see Exhibit 5 for full comparison and 510(k) numbers and Exhibit 10 for references.
1
Image /page/1/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 image of three human profiles facing right, with flowing lines representing hair or clothing.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 3 1899
Mr. Kenneth J. Berk Director, Pulpdent Corporation 80 Oakland Street 02472 Watertown, MA
Re : K993683 Pulpdent UNO-DUO Trade Name: Requlatory Class: II Product Code: KLE Dated: October 22, 1999 November 1, 1999 Received:
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 regulations 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
2
Page 2 - Mr. Berk
obligation you might have under sections 531 through 542 of obligation you might have 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 debeling of substantial equivalence of your device to a legally marketed predicate device results in a classification for your markeed production 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 origios or centitled, "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.fdp.gov/cdrh/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Timothy A. Diredtor Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
INDICATIONS FOR USE STATE
510 (k) Number (if known)
PULPDENT DENTASTIC UNO-DUO KIT Device Name
Indications for Use:
PULPDENT DENTASTIC UNO-DUO is a kit containing DenTASTIC UNO, a singlecomponent light cure dental primer / bonding resin [K 974014] and a Dual Cure Catalyst [K 926074, K 931710]. PULPDENT UNO-DUO is used by the dentist to bond to dentin, enamel, metals and resins in those situations in which a dual cure product is indicated.
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)
Susan Runne
Over-The-Counter Use
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital D 510(k) Number .