(87 days)
GAC OrthoLoc, GAC One-Step, Reliance Rely-a-Bond No Mix Orthodontic Adhesive, Reliance Rely-a-Bond w/Fluoride No Mix Adhesive
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No
The document describes a chemical adhesive and does not mention any computational or data-driven components.
No.
The device is an adhesive used to bond orthodontic brackets to teeth, which is a structural or supportive function rather than a therapeutic one. Therapeutic devices are typically intended to treat or prevent a disease or condition, or to restore function.
No
The device is described as an adhesive used to bond orthodontic brackets to teeth, which is a therapeutic rather than a diagnostic function.
No
The device is a chemical adhesive product, not a software-only medical device. The description clearly outlines a material used for bonding orthodontic brackets.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "adhere orthodontic brackets to tooth surfaces." This is a direct application to the patient's body for a therapeutic purpose (orthodontic treatment).
- Device Description: The description reinforces its use as an adhesive for orthodontic brackets on tooth surfaces.
- 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, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (on the body) for a structural and therapeutic purpose.
N/A
Intended Use / Indications for Use
Pulpdent No-Mix Orthodontic Bracket Adhesive is a self-cure orthodontic bracket adhesive used with a liquid primer and an enamel etching gel (38% phosphoric acid gel) to adhere orthodontic brackets to tooth surfaces.
Product codes (comma separated list FDA assigned to the subject device)
DYH
Device Description
PULPDENT No-Mix Orthodontic Bracket Adhesive is a fluoride-releasing, self-cure orthodontic bracket adhesive used with a liquid primer and an enamel etching gel (38% phosphoric acid gel) to adhere orthodontic brackets to tooth surfaces.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
tooth surfaces
Indicated Patient Age Range
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Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
GAC OrthoLoc, GAC One-Step, Reliance Rely-a-Bond No Mix Orthodontic Adhesive, Reliance Rely-a-Bond w/Fluoride No Mix Adhesive
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.
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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
2,2
510 k Premarket Notification
Pulpdent No-Mix Orthodontic Bracket Adhesive
EXHIBIT 2
MAR 1 4 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 Telephone: Fax:
617-926-6666 617-926-6262
DEVICE:
Trade Name: PULPDENT No-Mix Orthodontic Bracket Adhesive Classification Name: Adhesive, Bracket and Tooth Conditioner, Resin FDA Product Code: DYH. Part 872.3750
PREDICATE DEVICES:
GAC OrthoLoc GAC One-Step Reliance Rely-a-Bond No Mix Orthodontic Adhesive Reliance Rely-a-Bond w/Fluoride No Mix Adhesive
DESCRIPTION AND INTENDED USE:
PULPDENT No-Mix Orthodontic Bracket Adhesive is a fluoride-releasing, self-cure orthodontic bracket adhesive used with a liquid primer and an enamel etching gel (38% phosphoric acid gel) to adhere orthodontic brackets to tooth surfaces.
COMPARISON WITH PREDICATE PRODUCTS:
PULPDENT No Mix Orthodontic Adhesive is substantially equivalent in composition and intended use to the predicate product 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
Image /page/1/Picture/1 description: The image is a black and white circular logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around the perimeter. In the center of the circle is a stylized symbol that resembles an abstract human figure or bird-like shape, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 4 2002
Mr. Kenneth J. Berk Director Pulpdent Corporation 80 Oakland Street Watertown, Massachusetts 02472
Re: K014133
Trade/Device Name: Pulpdent No-Mix Orthodontic Bracket Adhesive Regulation Number: 872.3750 Regulation Name: Adhesive, Bracket and Tooth Conditioner, Resin Regulatory Class: II Product Code: DYH Dated: December 11, 2001 Received: December 17, 2001
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 (2012) 1) 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/dsmamain.html
Sincerely vours
Timothy A 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
KO14133
510 (k) Number (if known)
PULPDENT NO MIX ORTHODONTIC BRACKET ADHESIVE Device Name
Indications for Use:
Pulpdent No-Mix Orthodontic Bracket Adhesive is a self-cure orthodontic bracket adhesive used with a liquid primer and an enamel etching gel (38% phosphoric acid gel) 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 | ||
|---|---|---|
| (Per 21 CFR 801.109) | or | Over-The-Counter Use |
| (Division Sign-Off) | ||
| Division of Dental, Infection Control, | ||
| and General Hospital Devices | ||
| K014133 |
F 1 (k) Number _
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