(55 days)
ClearTemp is a provisional cement used for luting of thin translucent veneer restorations.
ClearTemp is a light curable, temporary cement used specifically for luting thin translucent veneers on teeth.
The provided document describes a 510(k) submission for a dental cement called ClearTemp. The submission focuses on establishing substantial equivalence to a predicate device (TempBond Clear by Sybron Dental Specialties) through various bench tests and a literature review. However, it does not contain information about a study proving the device meets specific numerical acceptance criteria in a clinical setting, nor does it detail studies typically associated with AI/ML-driven medical devices (e.g., test set sample sizes, ground truth establishment, expert adjudication, MRMC studies, or standalone algorithm performance).
Therefore, the requested information, particularly regarding studies that prove the device meets acceptance criteria in a way that involves human perception, expert adjudication, or AI performance metrics, is not present in the provided text. The document focuses on demonstrating comparable physical and chemical properties to a predicate device.
1. A table of acceptance criteria and the reported device performance
The document lists various tests used to compare ClearTemp to its predicate device (TempBond Clear), but it does not specify numerical acceptance criteria. Instead, it states that ClearTemp should perform "as well or better than" or be "comparable to" the predicate device and competitors. The table below summarizes the functions tested and the general performance goal stated.
| Function | Acceptance Criteria (Stated Goal) | Reported Device Performance |
|---|---|---|
| Flexural Strength | Higher than competitors (for strength), comparable to most competitors (for modulus) | Performs as well or better than the predicate device. |
| Hardness | Within competitors' range | Performs as well or better than the predicate device. |
| Compressive Strength | High numbers according to competitors are acceptable | Performs as well or better than the predicate device. |
| Depth of Cure | At the high end of competitors | Performs as well or better than the predicate device. |
| Ambient Light Sensitivity | Low times in this category | Performs as well or better than the predicate device. |
| Sorption | Low readings | Performs as well or better than the predicate device. |
| Film Thickness | (Implied to be comparable/acceptable) | Performs as well or better than the predicate device. |
| Radiopacity | Clear product shows up during an X-ray (implied to be comparable) | Performs as well or better than the predicate device. |
| Sorption Solubility | No degradation in solutions or saliva (implied to be comparable) | Performs as well or better than the predicate device. |
2. Sample size used for the test set and the data provenance
The document refers to "in-house testing" and "bench tests" but does not specify sample sizes for these tests or the data provenance (e.g., country of origin, retrospective/prospective). These are laboratory tests, not clinical studies with patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable as the study described involves bench testing (physical and chemical properties of a dental cement), not expert-based image interpretation or clinical diagnosis that would require ground truth established by experts.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not applicable for the same reasons as point 3.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
An MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic tools assisting human readers, which is not the subject of this 510(k) submission.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
A standalone performance study of an algorithm was not done. This device is a dental cement, not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The document describes "bench tests" which assess physical and chemical properties of the material. The "ground truth" for these tests would be established through laboratory measurements and established test methodologies (e.g., ISO standards for material properties), not expert consensus, pathology, or outcomes data.
8. The sample size for the training set
This information is not applicable as there is no training set mentioned or implied for this non-AI medical device.
9. How the ground truth for the training set was established
This information is not applicable for the same reasons as point 8.
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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: | |
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| Title: | |
| Telephone: | |
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| 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
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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 usedfor luting of thintranslucent veneerrestorations. | |
|---|---|---|---|
| TempBond Clear | K053565 | EMA | TempBond Clear withTriclosan is a dual cured,temporary, eugenol free,transparent, resin basedcement with triclosandesigned to be used inconjunction withtemporary restorationssuch as crowns, bridges,inlays, onlays and splints. |
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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
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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.
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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.
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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
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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)
§ 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.