(219 days)
No
The device description and performance studies focus on the material properties and biocompatibility of a resin-based dental dam, with no mention of AI or ML.
No
The device primarily serves as a protective barrier and block-out material for dental applications, and there is no indication that it is used to treat a disease, injury, or condition.
No
The document describes a protective barrier material used in dentistry, not a device intended for diagnosing medical conditions.
No
The device description clearly states it is a "resin-based, light-cured protective barrier material" and a "light-cured, resin dam material," indicating it 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 to "protect dental materials or tissues" as a "protective barrier material." This is a physical barrier function applied directly to the patient's body (or materials within the body).
- Device Description: The description reinforces the physical barrier function by stating it "block[s] out or protect[s] dental materials or tissues" and "form[s] a protective barrier."
- Lack of Diagnostic Purpose: There is no mention of the device being used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. IVDs are used to test things like blood, urine, tissue samples, etc., to help diagnose or monitor a condition.
This device falls under the category of a dental material used for protection during dental procedures, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
Triumph Resin Dam is a resin-based, light-cured protective barrier material recommended to protect dental materials or tissues.
For Use only by a Licensed Dentist. Rx Use Only.
Product codes
EIE
Device Description
Triumph Resin Dam is a light-cured, resin dam material recommended to block out or protect dental materials or tissues. Triumph contains polymerizable monomers that when light-cured form a protective barrier. When set the resin has a low strength allowing its removal from the protected surfaces.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
dental materials or tissues
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Licensed 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
Triumph Resin Dam was evaluated for biocompatibility as per ISO 10993 "Biological Eval-BIOCOMPATIBILITY uation of Medical Devices". Tests conducted were cytotoxicity, human skin irritation and skin sensitization. Triumph Resin Dam was found to be biocompatible. For ISO10993 Cytotoxicity Testing, Triumph Resin Dam had a Grade "0". "Reactivity. None". As per ISO 10993 "Tests for Irritation and Skin Sensitization", with respect to irritation Triumph was graded as "No reaction", with respect to Skin sensitization, Triumph was rated as Grade "0" - "No visible change".
Key Metrics
Results - Biological Evaluation of Triumph Resin Dam - per ISO 10993
Test Method: Cytotoxicity, Result: 0 (None)
Test Method: Human Skin Irritation Test, Result: 0 (No Reaction)
Test Method: Skin Sensitization Test, Result: 0 (No Visible Change)
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.6300 Rubber dam and accessories.
(a)
Identification. A rubber dam and accessories is a device composed of a thin sheet of latex with a hole in the center intended to isolate a tooth from fluids in the mouth during dental procedures, such as filling a cavity preparation. The device is stretched around a tooth by inserting a tooth through a hole in the center. The device includes the rubber dam, rubber dam clamp, rubber dam frame, and forceps for a rubber dam clamp. This classification does not include devices intended for use in preventing transmission of sexually transmitted diseases through oral sex; those devices are classified as condoms in § 884.5300 of this chapter.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9. If the device is not labeled or otherwise represented as sterile, it is exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180 of this chapter, with respect to general requirements concerning records, and § 820.198 of this chapter, with respect to complaint files.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 18, 2016
DENALI CORPORATION Dr. Jan G. Stannard President 134 Old Washington Street Hanover, Massachusetts, 02339
Re: K151945
Trade/Device Name: Triumph Resin Dam Regulation Number: 21 CFR 872.6300 Regulation Name: Rubber dam and accessories Regulatory Class: I Product Code: EIE Dated: January 14, 2016 Received: January 19, 2016
Dear Dr. Stannard:
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.
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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 (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Tina Kiang -
for Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE STATEMENT
510 (k) Number K151945 (if known)
Device Name
Triumph Resin Dam
Indications for Use:
Triumph Resin Dam is a resin-based, light-cured protective barrier material recommended to protect dental materials or tissues.
For Use only by a Licensed Dentist. Rx Use Only.
Please do not write below this line. Continue on another page if needed.
Concurrence of CDRH, Office of Device Evaluation (ODE)
区
Prescription Use (Per 21 CFR 801.109)
or
Over-The-Counter Use
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510 (k) Summary
Image /page/3/Picture/2 description: The image shows the logo and contact information for Denali Corporation. The logo features a stylized graphic with a blue sphere and a curved line. The text includes the company name, address (134 Old Washington Street, Hanover, MA 02339 USA), phone number (781.826.9190), fax number (781.826.4465), and website (denalicorporation.com).
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February 17, 2016
| ADDRESS | DENALI CORPORATION
134 Old Washington Street / Hanover, MA 02339-1629 |
|--------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| OWNER/CONTACT PERSON | Dr. Jan G. Stannard
TEL: 781-826-9190 / FAX: 781-826-4465 / j.stannard@denalicorporation.com |
| TRADE NAME | Triumph Resin Dam |
| COMMON NAME | Resin Dam |
| CLASSIFICATION NAME | RUBBER DAM AND ACCESSORIES, CLASS I (21 CFR 872.6300,
Product EIE |
| REGISTRATION | 3006367836 |
| PRIMARY PREDICATE DEVICE | OpalDam (K971284) Ultradent Products, Inc. |
| REFERENCE PREDICATE DEVICE | BriteSmile (K010935), BriteSmile Inc, |
| EQUIVALENCE | The primary predicate product has been found to be substantially equivalent under the
510(k) premarket notification process as Class I Dental Devices under
CFR 872.6300, RUBBER DAM AND ACCESSORIES. |
| DEVICE DESCRIPTION | Triumph Resin Dam is a light-cured, resin dam material recommended to block out or
protect dental materials or tissues. Triumph contains polymerizable monomers that when
light-cured form a protective barrier. When set the resin has a low strength allowing
its removal from the protected surfaces. |
| INTENDED USE | Triumph Resin Dam is a resin-based, light-cured protective barrier material recom-
mended to protect dental materials or tissues. For Use only by a Licensed Dentist.
Rx Use Only. |
| TECHNOLOGICAL
CHARACTERISTICS
SUMMARY and Intended Use | Triumph Resin Dam has the same technological characteristics as the primary predicate
device OpalDam including: design, similar composition, biocompatibility, performance,
principle of operation, ageing, intended use, physical characteristics, setting, depth of cure
and mechanical properties; compressive strength and hardness,
as summarized in the table below. The inclusion of protection of
dental materials does not alter its intended use nor, does it alter
its function. Materials as well as tissue may be affected by
bleaching actions. |
| COMPARISON OF TRIUMPH RESIN DAM TO PRIMARY PREDICATE PRODUCT | ||
|---|---|---|
| PROPERTY | Triumph Resin Dam | Opal Dam |
| Intended Use | Resin barrier used to isolate and protect dental | |
| materials and tissues. | Resin barrier used to isolate and | |
| protect dental materials and tissue | ||
| Composition | Urethane acrylates, silica, titanium dioxide, | |
| light curing chemistry. | Di-urethane di-methacrylate, filler | |
| (possibly mica), light curing chemistry. | ||
| Light Cure Capability | Yes | Yes |
| Light Cure Setting Time | Yes, |