(55 days)
Not Found
No
The summary describes a dental cement and its physical properties, with no mention of AI or ML.
No
The device is a temporary cement for luting veneers, which is a restorative material and not intended for therapeutic purposes like treating disease or injury.
No
The device, ClearTemp, is described as a "provisional cement used for luting of thin translucent veneer restorations." Its function is to temporarily bond dental veneers, not to identify or diagnose any medical condition.
No
The device description clearly states it is a "light curable, temporary cement," which is a physical material, not software. The performance studies also focus on material properties like strength, hardness, and depth of cure.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "luting of thin translucent veneer restorations." This describes a process performed on the patient's teeth, not a test performed on a sample taken from the patient.
- Device Description: The device is a "light curable, temporary cement used specifically for luting thin translucent veneers on teeth." This further reinforces its use as a material applied directly to the patient's teeth.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing a sample (blood, urine, tissue, etc.)
- Providing diagnostic information about a patient's health condition
- Using reagents or other materials to perform a test
In summary, ClearTemp is a dental material used for a restorative procedure, not a diagnostic test performed in vitro.
N/A
Intended Use / Indications for Use
ClearTemp is a provisional cement used for luting of thin translucent veneer restorations.
Product codes (comma separated list FDA assigned to the subject device)
EMA
Device Description
ClearTemp is a light curable, temporary cement used specifically for luting thin translucent veneers on teeth.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
teeth
Indicated Patient Age Range
The product can be used on any age patient when they have had veneers professionally installed.
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)
The following bench tests were conducted during the R & D phase on ClearTemp and compared to Sybron Dental Specialties TempBond Clear (K053565):
- Flexural Strength: This test will show the strength of the bond during stress. The modulus side of this test shows the strength at which flexing the bond occurs. We prefer the product to be comparable to most of our competitors.
- Hardness: This test shows the hardness of the bond. We prefer to stay within our competitors range.
- Compressive: This test shows different forces on the resin. High numbers according to our competitors is acceptable.
- Depth of Cure: This test shows how far a curing light penetrates into the cure. We want to stay at the high end of our competitors.
- Ambient Light Sensitivity: This test shows the that the product will cure in ambient light. It shows working time with the product and cure time of the product. We want low times in this category.
- Sorption – This test shows how much water the resin absorbs. We want low readings on this test.
- Film thickness testing bond strength at a defined thickness.
- Radiopacity verifying how clear the product shows up during an Xray.
- Sorption Soluability- testing whether the product degrades in solutions or saliva
A complete Clinical Summary of ClearTemp is included in Section 20. We conducted a literature study to show safety and effectiveness of ClearTemp.
The efficacy or suitability to the intended purpose of ClearTemp has been demonstrated by a combination of in-house testing and side-by-side comparisons to predicate devices currently on the market. Results of our bench testing indicates that ClearTemp performs as well or better than the predicate device currently on the market.
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.
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/0 description: The image shows a sequence of characters that appear to be handwritten. The sequence starts with the letter 'K', followed by three instances of the number '1'. After that, there is a '0', another '1', and finally a '7'. The characters are written in a simple, clear style, making them easily readable.
Section 5
JUN - 6 2011
Traditional 510(k) Summary
This summary of the Traditional 510(k) substantial equivalence information is being submitted in accordance with the requirements of 21 CFR 807 .92.
Applicant's Name and Address
Ultradent Products Inc. 505 West 10200 South South Jordan, UT 84095
| Contact Person: | |
|---|---|
| Title: | |
| Telephone: | |
| FAX: | |
| Date Summary Prepared: |
Diane Rogers Regulatory Affairs Manager 800-552-5512 x4491, 801-553-4491 801-553-4609 May 31, 2011
Name of the Device
Trade Name: Common Name: Device Classification: Classification Product Code: ClearTemp Dental Cement = EMA
Legally Marketed Predicate Devices to Which Equivalence is Claimed
The predicate device is: TempBond Clear by Sybron Dental Specialties (K053565)
Description of Device: ClearTemp is a light curable, temporary cement used specifically for luting thin translucent veneers on teeth.
Intended Use of the Device: ClearTemp is a provisional cement used for luting of thin translucent veneer restorations.
The following table shows that each of these devices are similar as test results comparing these devices show similar results. The devices are so equivalent that both of these companies follow standards that
4 Page
1
show us how to test this type of a device and in Section 18 "Performance and Bench", you will see that test results show the devices have the same technological characteristics.
| Function | ClearTemp | TempBond Clear
(K6053565) |
|-------------------|-----------|------------------------------|
| Flexural Strength | × | × |
| Hardness | × | × |
| Compressives | × | × |
| Cure Time | × | × |
| Depth of Cure | × | × |
| Sorption Solution | × | × |
| Radiopacity | × | × |
| Ambient Light | × | × |
| Sensitivity | | |
| Film Thickness | × | × |
Similarities in the Indications for Use:
| ClearTemp | | EMA | Provisional cement used
for luting of thin
translucent veneer
restorations. |
|----------------|---------|-----|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| TempBond Clear | K053565 | EMA | TempBond Clear with
Triclosan is a dual cured,
temporary, eugenol free,
transparent, resin based
cement with triclosan
designed to be used in
conjunction with
temporary restorations
such as crowns, bridges,
inlays, onlays and splints. |
2
Brief Description of Testing Performed
The following bench tests were conducted during the R & D phase on ClearTemp and compared to Sybron Dental Specialties TempBond Clear (K053565)
- a. Flexural Strength This test will show the strength of the bond during stress. A higher number than our competitors is good. The modulus side of this test shows the strength at which flexing the bond occurs. We prefer the product to be comparable to most of our competitors.
- b. Hardness This test shows the hardness of the bond. We prefer to stay within our competitors range.
- Compressives This test shows different forces on the resin. High numbers according to our ن competitors is acceptable.
- d. Depth of Cure This test shows how far a curing light penetrates into the cure. We want to stay at the high end of our competitors.
- e. Ambient Light Sensitivity This test shows the that the product will cure in ambient light. It shows working time with the product and cure time of the product. We want low times in this category.
- ﻨﺖ Sorption – This test shows how much water the resin absorbs. We want low readings on this test.
- Film thickness testing bond strength at a defined thickness. g.
- h. Radiopacity verifying how clear the product shows up during an Xray.
- i. Sorption Soluability- testing whether the product degrades in solutions or saliva
Clinical Summary
A complete Clinical Summary of ClearTemp is included in Section 20. We conducted a literature study to show safety and effectiveness of ClearTemp. ClearTemp is a provisional cement used for luting of thin translucent veneer restorations. The product can be used on any age patient when they have had veneers professionally installed. The device has the same technological characteristics.compared to Sybron Dental Specialities TempBond Clear. These materials have been widely used by numerous manufacturers in the dental industry.
The efficacy or suitability to the intended purpose of ClearTemp has been demonstrated by a combination of in-house testing and side-by-side comparisons to predicate devices currently on the market. Results of our bench testing indicates that ClearTemp performs as well or better than the predicate device currently on the market.
Summary Risk/Benefit Review
Considering the safe history of our predicate, TempBond Clear by Sybron Dental Specialities (K053565) ClearTemp is considered a safe medical device. Our research indicates that our predicate has been used by many dentists and large group practices in the United States and purchased by a large
6 | Paul C
3
number of international distributors. To date, there have been no reported complaints of local or systemic adverse effects associated with the use of these products.
ClearTemp was tested for biocompatibility in Cytotoxicity, Sensitization, Irritation and Genotoxicity tests according to ISO 10993-1:2009. An abstract of the testing.along with signed test reports are included in Section 15 "Biocompatibility" of this submission.
In conclusion, ClearTemp has been designed and manufactured with the intended use and claims for the product in mind. Scientific literature, etc. has been collected and evaluated to determine safety and efficacy of similar products used for the same indication. Following the clinical review as documented above, Ultradent Products, Inc. deems that when this device is used under the conditions and for the purposes intended, it will not compromise the clinical condition or the safety of the patient and the association with its use constitutes acceptable risks when weighed against the benefits to the patient. Therefore, the product is compatible with a high level of protection of health and safety and may be released to the market.
7 Page
4
Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Ms. Diane Rogers Regulatory Affairs Manager Ultradent Products, Incorporation 505 West 10200 South South Jordan, Utah 84095
Re: K111017
Trade/Device Name: ClearTemp Regulation Number: 21 CFR 872.3275 Regulation Name: Dental Cement Regulatory Class: II Product Code: EMA Dated: April 1, 2011 Received: April 12, 2011
JUN - 6 2011
Dear Ms. Rogers:
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.
5
Page 2- Ms. Rogers
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/Resourcesfor You/Industry/default.htm.
Sincerely vours.
Th for
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Statement of Indications for Use
510(k) Number (if known):
Device Name: ClearTemp
Indications for Use:
ClearTemp is a provisional cement used for luting of thin translucent veneer restorations.
Prescription Use _ X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use _ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
510(k) Number:
Susan Ruane
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
(Posted November 13, 2003)