(48 days)
Not Found
Not Found
No
The description focuses on the chemical composition and function of a dental adhesive system, with no mention of AI or ML.
No.
The device is described as an adhesive system used to adhere orthodontic brackets to tooth surfaces, which is a supportive material rather than a device designed to directly treat a medical condition or restore health.
No
The device is described as an adhesive system used to bond orthodontic brackets to teeth, which is a treatment function, not a diagnostic one. It does not mention any role in identifying or characterizing a disease or condition.
No
The device description clearly states it is a "two-paste dental adhesive used with a self-cure, two-part sealant," indicating it is a physical material, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The PULPDENT Sealant/Paste Orthodontic Bracket Adhesive System is a dental adhesive used to physically attach orthodontic brackets to teeth. It does not analyze any biological specimens from the body.
- Intended Use: The intended use clearly states its purpose is to "adhere orthodontic brackets to tooth surfaces," which is a mechanical function, not a diagnostic one.
Therefore, based on the provided information, this device falls under the category of a dental adhesive, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
PULPDENT Sealant/Paste Orthodontic Bracket Adhesive System is a self-cure, two-paste dental adhesive used with a self-cure, two-part sealant to adhere orthodontic brackets to tooth surfaces.
Product codes (comma separated list FDA assigned to the subject device)
76 DYH, DYH
Device Description
PULPDENT Sealant/Paste Orthodontic Bracket Adhesive System is a self-cure, two-paste dental adhesive used with a self-cure, two-part sealant to adhere orthodontic brackets to tooth surfaces.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
tooth surfaces
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): 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.
Not Found
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
§ 872.3750 Bracket adhesive resin and tooth conditioner.
(a)
Identification. A bracket adhesive resin and tooth conditioner is a device composed of an adhesive compound, such as polymethylmethacrylate, intended to cement an orthodontic bracket to a tooth surface.(b)
Classification. Class II.
0
Pulpdent Sealant / Paste Orthodontic Bracket Adhesive System
EXHIBIT 2
K02013
FEB 2 8 2002
SUMMARY OF SAFETY AND EFFECTIVENESS DATA
RESPONSE TO SMDA OF 1990
Kenneth J. Berk 80 Oakland Street PO Box 780 Watertown, MA 02472 USA
617-926-6666 Telephone: Fax: 617-926-6262
DEVICE
TRADE NAME: PULPDENT Sealant/ Paste Orthodontic Bracket Adhesive System CLASSIFICATION NAME: Adhesive, Bracket and Tooth Conditioner, Resin FDA Product Code: 76 DYH, 21 CFR Part 872.3750
PREDICATE DEVICES:
GAC AccuBond Sealant/Paste Bonding System GAC ExactaBond Sealant/Paste Bonding System Reliance Excel Bonding Adhesive Reliance Phase 11 Sealant/Paste System 3M Concise Orthodontic Bond System
DESCRIPTION AND INTENDED USE:
PULPDENT Sealant/Paste Orthodontic Bracket Adhesive System is a self-cure, two-paste dental adhesive used with a self-cure, two-part sealant to adhere orthodontic brackets to tooth surfaces.
COMPARISON WITH PREDICATE PRODUCTS:
PULPDENT Sealant/Paste Orthodontic Bracket Adhesive System is substantially equivalent in composition and intended use to the products listed above. Please see Exhibit 4 for the entire comparison.
SAFETY AND EFFECTIVENESS:
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-to-risk ratio...both composites and glass ionomers 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. In addition, the predicate products listed above have been given 510 (k) premarket approval as Class II Dental Devices under CFR 872.3750.
1
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles an abstract caduceus or a bird-like figure with three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 8 2002
Mr. Kenneth J. Berk Director Pulpdent Corporation 80 Oakland Street Watertown, Massachusetts 02472
Re: K020115
Trade/Device Name: Pulpdent Sealant/Paste Orthodontic Bracket Adhesive Regulation Number: 872.3750 Regulation Name: Bracket Adhesive Resin and Tooth Conditioner Regulatory Class: II Product Codes: DYH Dated: January 04, 2002 Received: January 11, 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.
2
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/dsmarnain.html
Sincerely yours,
Tim A. Ulatowski Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
INDICATIONS FOR USE STATEMENT
510 (k) Number (if known)
Device Name: PULPDENT Sealant / Paste Orthodontic Bracket Adhesive System
KO20115
Indications for Use:
PULPDENT Sealant/Paste Orthodontic Bracket Adhesive System is a self-cure, two-paste dental adhesive used with a self-cure, two-part sealant to adhere orthodontic brackets to tooth surfaces.
Please do not write below this line. Continue on another page if needed.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use V (Per 21 CFR 801.109)
or
Over-The-Counter Use
Susan Rinn
(Division Sign-Off) Division of Dental, Infection Control, and General Hospita 510(k) Number_