(157 days)
Not Found
No
The device description and performance studies focus on the physical and mechanical properties of a dental cement, with no mention of AI or ML.
No
The device is a resin-based cement used for bonding dental restorations, which is not considered a therapeutic device. Therapeutic devices are typically used to treat or cure a disease or condition.
No
The device is a resin-based cement used for bonding dental restorations, performing a therapeutic or restorative function rather than diagnosing a condition.
No
The device is a resin-based cement, which is a physical material, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for bonding dental restorations (ceramic, metal, composite) in the mouth of a patient. This is a direct application to the body for a therapeutic purpose (securing a restoration).
- Device Description: The description confirms it's a cement used for bonding restorations.
- Lack of Diagnostic Purpose: There is no mention of this device being used to examine specimens (like blood, urine, tissue) outside the body to provide information for diagnosis, monitoring, or screening.
IVD devices are specifically designed to be used in vitro (outside the body) to analyze samples and provide diagnostic information. This device is used in vivo (inside the body) for a restorative procedure.
N/A
Intended Use / Indications for Use
Denali 501 Cement is a two part, resin-based cement recommended for the bonding of ceramic, metal and composite restorations. For Use only by a Licensed Dentist. Rx Use Only.
Product codes (comma separated list FDA assigned to the subject device)
EMA
Device Description
Denali 501 Cement is a two part, resin-based cement recommended for the bonding of ceramic, metal and composite restorations. Denali 501 contains polymerizable monomers that can set in either a light activated mode or set upon mixing Part A and Part B. When set the resin has a low solubility in water to act as a long term cement.
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
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
This assessment is based upon a comparison of the physical and mechanical characteristics (tensile strength, compressive strength), solubility, film thickness, depth of cure, and setting time. The results of these tests are consistent with values of Tempbond and Variolink.
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.
Cercom II Cement/Denali Corporation (K132393), Variolink Cement/Ivoclar (K971372), Tempbond with Triclosan Cement/Kerr (K053565).
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
§ 872.3275 Dental cement.
(a)
Zinc oxide-eugenol —(1)Identification. Zinc oxide-eugenol is a device composed of zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
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.(b)
Dental cement other than zinc oxide-eugenol —(1)Identification. Dental cement other than zinc oxide-eugenol is a device composed of various materials other than zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class II.
0
Image /page/0/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" around the perimeter. Inside the circle is an emblem featuring a stylized representation of three human profiles facing right, with flowing lines suggesting movement or connection.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 10,2014
Denali Corporation Jan G. Stannard President 134 Old Washington Street Hanover. MA 02339
Re: K141503
Trade/Device Name: Denali 501 Cement Regulation Number: 21 CFR 872.3275(b) Regulation Name: Dental Cement Regulatory Class: II Product Code: EMA Dated: August 7, 2014 Received: August 19, 2014
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.
1
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 Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/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 Small Manufacturers, International and Consumer Assistance 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.
Susan Runno DDS, mA
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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Image /page/2/Picture/1 description: The image shows the logo for Denali Corporation. The logo consists of a blue triangle with a sphere and orbital ring on the left side. To the right of the logo is the text "denali corporation" in a dark gray sans-serif font.
INDICATIONS FOR USE STATEMENT
510 (k) Number (if known)
Device Name
Denali 501 Cement
Indications for Use:
Denali 501 Cement is a two part, resin-based cement recommended for the bonding of ceramic, metal and composite restorations. 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)
风
Prescription Use (Per 21 CFR 801.109)
or
Over-The-Counter Use
3
510 (k) Summary
Image /page/3/Picture/1 description: The image shows the logo for Denali Corporation. The logo includes a blue and black geometric shape with a blue sphere and a gray orbit around it. The text "denali corporation" is written in gray next to the logo, and the address "134 Old Washington Street, Hanover, MA 02339 USA" is written in gray below the company name.
T 781.826.9190
F 781.826.4465
denalicorporation.com
| June 22, 2014
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 | Denali 501 Cement |
| COMMON NAME | Resin Cement |
| CLASSIFICATION NAME | DENTAL CEMENT (21 CFR 872.3275, Product Code EMA) |
| REGISTRATION | 3006367836 |
| PREDICATE DEVICES | Cercom II Cement/Denali Corporation (K132393), Variolink Cement/Ivoclar (K971372),
Tempbond with Triclosan Cement/Kerr (K053565). |
| EQUIVALENCE | The predicate products have been found substantially equivalent
under the 510(k) premarket notification process as Class II Dental
Devices under CFR EMA 872.3275, Dental Cement. |
| DEVICE DESCRIPTION | Denali 501 Cement is a two part, resin-based cement recommended for
the bonding of ceramic, metal and composite restorations. Denali 501 contains poly-
merizable monomers that can set in either a light activated mode or set upon mixing
Part A and Part B. When set the resin has a low solubility in water to act as a long term
cement. |
| INTENDED USE | Denali 501 Cement is a resin-based cement recommended for
the bonding of ceramic, metal and composite restorations.
For Use only by a Licensed Dentist. Rx Use Only. |
| TECHNOLOGICAL
CHARACTERISTICS
SUMMARY | Denali 501 Cement has the same technological characteristics
as the predicate devices Temp Bond and Variolink including: design,
composition, biocompatibility, performance, ageing, intended use, safety and
effectiveness, physical characteristics, setting, solubility, film thickness, depth of cure
and mechanical properties (tensile and compressive strength). |
| BIOCOMPATIBILITY | Denali 501 Cement was found to be biocompatible, and is consistent in formulation
to Tempbond and Variolink, in its intended use, biocompatibility, and properties
compared to Tempbond and Variolink. |
| SUBSTANTIAL
EQUIVALENCE
DETERMINATION AND
SUMMARY | Denali 501 Cement is substantially equivalent in design,
composition, biocompatibility, performance, ageing, intended use, and safety and
effectiveness to Tempbond and Variolink. This assessment is based upon
a comparison of the physical and mechanical characteristics (tensile strength, com
pressive strength), solubility, film thickness, depth of cure, and setting time.
The results of these tests are consistent with values of Tempbond and Variolink. |
| CONCLUSIONS | Denali 501 Cement has been found to be substantially equivalent
in design, composition, ageing, biocompatibility, performance, intended use, and
safety and effectiveness to Tempbond and Variolink. |