(111 days)
No
The device description and intended use clearly define it as a light-cure orthodontic adhesive composite, with no mention of AI or ML capabilities. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No
The device is an adhesive composite used for bonding orthodontic brackets, which is a supportive rather than a therapeutic function. While it releases ions, its primary role is structural bonding, not treating a disease or condition.
No
The device is an adhesive composite used for bonding orthodontic brackets, which is a treatment procedure, not a diagnostic one.
No
The device description clearly states it is a "light-cure orthodontic adhesive composite," 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 is for the direct bonding of orthodontic brackets. This is a procedure performed directly on a patient's teeth, not on a sample of biological material outside the body.
- Device Description: The description details a composite material used for bonding, not a reagent, instrument, or system intended for the examination of specimens from the human body.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as analyzing biological samples (blood, urine, tissue), detecting specific substances, or providing diagnostic information.
Therefore, PULPDENT OBA-MCP is a medical device used in a clinical setting for a therapeutic/restorative purpose, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
PULPDENT OBA-MCP is a light-cure orthodontic adhesive composite for the direct bonding of orthodontic brackets. For dental professional use only.
Product codes (comma separated list FDA assigned to the subject device)
DYH
Device Description
PULPDENT OBA-MCP is a light-cure orthodontic adhesive composite containing modified calcium phosphate that releases fluoride, calcium, and phosphate ions into the oral environment. OBA-MCP is not formulated with Bisphenol A. BisGMA, or BPA derivatives.
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
Dental professional use only.
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)
Pulpdent OBA-MCP is substantially equivalent to the predicate device, Pulpdent OBA, which has an established history of safe and effective use as a dental material. Pulpdent OBA-MCP is also substantially equivalent in chemical composition to the reference device, Pulpdent Solo Flowable Composite with MCP, which has been tested with a Cytotoxicity Test (ISO 10993-5 2009) and an Implantation Test (ANSI/ADA Specification 41 and ISO 7405) and found to be biocompatible.
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 OBA-Orthodontic Bracket Adhesive, Pulpdent Corporation, K911286, 3M Unitek Transbond XT Light Cure Adhesive, 3M, K880393, GC Fuji ORTHO LC Liquid, Fuji, K950556
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.
PULPDENT Solo Flowable Composite with MCP, Pulpdent Corporation, K153249
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
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
January 17, 2018
Pulpdent Corporation % Roger Mastrony President MedTek LLC 2516 Kettle Creek Court Lincolnton, North Carolina 28092
Re: K173020
Trade/Device Name: OBA-MCP, Orthodontic Bracket Adhesive with MCP Regulation Number: 21 CFR 872.3750 Regulation Name: Bracket Adhesive Resin And Tooth Conditioner Regulatory Class: Class II Product Code: DYH Dated: December 12, 2017 Received: December 18, 2017
Dear Roger Mastrony:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good
1
manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Mary S. Runner -S
For Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K173020
Device Name
PULPDENT OBA-MCP - Orthodontic Bracket Adhesive with MCP
Indications for Use (Describe)
PULPDENT OBA-MCP is a light-cure orthodontic adhesive composite for the direct bonding of orthodontic brackets. For dental professional use only.
Type of Use (Select one or both, as applicable)
| ☒ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ----------------------------------------------------------------------------------------- |
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|
| ---------------------------------------------------------------------------------------- |
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3
PULPDENT CORPORATION
80 Oakland Street Watertown, MA 02472 USA
Tel: 617 926 6666 Fax: 617 926 6262 Email: Pulpdent@pulpdent.com
510(k) SUMMARY K173020
DATE OF SUBMISSION: 1/11/18
OWNER: Pulpdent Corporation 80 Oakland Street Watertown, MA 02472 USA
- CONTACT: Roger S. Mastrony 2516 Kettle Creek Court Lincolnton NC 28092 Tel: 1 203 640 5047 / Email: rogermastrony@gmail.com
TYPE OF SUBMISSION: Traditional 510(k).
DEVICE:
Trade Name: PULPDENT OBA-MCP- Orthodontic Bracket Adhesive with MCP Device Class: II Review Panel: Dental Classification Name: Orthodontic Bracket Adhesive FDA Product Code: DYH; 21 CFR Part 872.3750
PREDICATE DEVICE:
PULPDENT OBA-Orthodontic Bracket Adhesive, Pulpdent Corporation, K911286
REFERENCE DEVICE:
PULPDENT Solo Flowable Composite with MCP, Pulpdent Corporation, K153249
ADDITIONAL PREDICATE DEVICES:
Comparable chemical compositions for the below referenced devices can be found in the Safety Data Sheets for the each product.
3M Unitek Transbond XT Light Cure Adhesive, 3M, K880393 (file 046 in the e-copy)
GC Fuji ORTHO LC Liquid, Fuji, K950556 (file 045 in the e-copy)
DESCRIPTION: PULPDENT OBA-MCP is a light-cure orthodontic adhesive composite containing modified calcium phosphate that releases fluoride, calcium, and phosphate ions into the oral environment. OBA-MCP is not formulated with Bisphenol A. BisGMA, or BPA derivatives.
The standards applicable to the subject device, and referenced within the submission, include: ાડવ 4049:2009 Dentistry – Polymer based filling, restorative and luting materials, ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity, ISO 7405:2008 Dentistry -Evaluation of biocompatibility of medical devices used in dentistry, ANSI/ADA Standard No. 41 Evaluation of Biocompatibility of Medical Devices Used in Dentistry - ADA41-2005D.
INDICATIONS FOR USE: PULPDENT OBA-MCP is a light cure orthodontic adhesive composite for the direct and indirect bonding of orthodontic brackets. For dental professional use only.
4
80 Oakland Street Watertown, MA 02472 USA
BIOCOMPATIBILITY EVALUATION:
PULPDENT OBA-MCP is substantially equivalent to the predicate device, Pulpdent OBA, which has an established history of safe and effective use as a dental material. Pulpdent OBA-MCP is also substantially equiavalent in chemcial composition to the reference device, Pulpdent Solo Flowable Composite with MCP, which has been tested with a Cytotoxicity Test (ISO 10993-5 2009) and an Implantation Test (ANSI/ADA Specification 41 and ISO 7405) and found to be biocompatible.
DEVICE COMPARISON WITH PREDICATE AND REFERENCE PRODUCTS
The predicate product has been found to be substantially equivalent under the 510(k) Premarket Notification process as Class II Dental Device under CFR 872.3750, Code DYH.
| | Pulpdent OBA – MCP
Orthodontic Bracket
Adhesive with MCP | Predicate Product:
PULPDENT OBA, K911286,
Orthodontic Bracket Adhesive | Reference Product: optional
PULPDENT Solo Flowable
Composite with MCP, K153249 |
|----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| DESCRIPTION | Light cured, adhesive
composite, with modified
calcium phosphate | Light cured, adhesive composite | Light cured, resin composite with
modified calcium phosphate |
| TECHNOLOGY /
MECHANISM OF
ACTION | Direct and indirect bonding of
orthodontic brackets | Direct and indirect bonding of
orthodontic brackets | Dental cavity filler and restorative |
| INDICATIONS FOR
USE | Light cure orthodontic adhesive
composite for the direct and
indirect bonding of orthodontic
brackets | Orthodontic bracket adhesive | Dental restorative, base and liner |
| COMPOSITION | Aliphatic Dimethacrylates,
Diurethane dimethacrylate, Bis
(2-(Methacryloyloxy) Ethyl)
Phosphate, Barium glass,
Strontium glass, MCP (Modified
calcium phosphate),
Silica, Sodium Fluoride,
Camphorquinone (photo-
initiators) | 1,6 Hexamethylene
Dimethacrylate, BisGMA (Bis [4-2
(Hydroxy-3-Methacryloxy Propyl)
Phenyl] Propane-2),
Dimethylaminoethylmethacrylate,
Silanated Barium Glass, Fumed
Silica, Sodium Fluoride,
Camphorquinone, (photo-
initiators) | Aliphatic Dimethacrylates,
Diurethane dimethacrylate, Bis (2-
(Methacryloyloxy) Ethyl) Phosphate,
Barium glass, Strontium glass, MCP
(Modified calcium phosphate),
Sodium Fluoride, Camphorquinone
(photo-initiators), colorants |
| PHYSICAL PROPERTIES | | | |
| Appearance | Stiff, off-white paste | Stiff, off-white paste | Tooth shade paste |
| Specific gravity | 1.9 g/ml | 1.820 g/ml | 1.810 g/ml |
| Water Absorption | 1.01% | | 1.73% |
| Fluoride Release | 422 µg/g | Yes | Yes |
| Phosphate Release | 182 µg/g | No | Yes |
| Calcium Release (pH 4) | 96 µg/g | No | Yes |
5
PULPDENT CORPORATION
80 Oakland Street Watertown, MA 02472 USA
| | Pulpdent OBA – MCP
Orthodontic Bracket
Adhesive with MCP | Predicate Product:
PULPDENT OBA, K911286,
Orthodontic Bracket Adhesive | Reference Product: optional
PULPDENT Solo Flowable
Composite with MCP, K153249 |
|-------------------------------|-----------------------------------------------------------------------|-------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------|
| Compressive
Strength | 353 MPa | --- | 330 ±47.9 |
| Flexural Strength | 112.5 MPa | --- | 129 ±18.7 MPa |
| Diametral Tensile
Strength | 51 MPa | --- | 46.5 MPa |
| Light cure set times | 20 seconds | 20 seconds | 20 seconds |
Similarities
Pulpdent OBA-MCP and the predicate product, OBA, both share the same technology and mechanism of action, as an orthodontic bracket adhesive. They have essentially the same physical properties and nearly identical chemical formulations.
Differences
Pulpdent OBA-MCP differs from Pulpdent OBA with the addition of MCP (Modified Calcium Phosphate). Additionally, the BisGMA has been removed from the original OBA formulation.
Discussion of the Differences
MCP, or Modified Calcium Phosphate, is a methacrylate moiety, with stabilized calcium and phosphate ions, that is used as a filler in dental materials. In the natural course of the tooth, and its demineralization and remineralization processes in acidic oral environments, there is an ongoing exchange of biologically available calcium and phosphate ions. The addition of calcium and phosphate ions to dental products can be seen in many premarket approved devices. Biocompatability testing performed on products with a similar chemcial composition (including the reference device) have confirmed that a calcium and phospahte addition is biocompatible (see file 012 Biocompatabiltiy Evaluation). It has also been shown that the enamel bond strength of orthodontic materials containing a calcium phosphate moiety exhibits a comparable bond strength to commercially available cements without calcium phosphate. (Zhang, et.al., file ecopy)
Conclusion
Taking into account the above similarities and differences, Pulpdent OBA-MCP Orthodontic Bracket Adhesive with MCP, is substantially equivalent, in design, performance and indications for use, to the predicate product, Pulpdent OBA - Orthodontic Bracket Adhesive.