CERCOM CEMENT by DENALI R&D CORPORATION

Here's an analysis of the provided text regarding the acceptance criteria and study for the CERCOM Cement device, based on the information available in the 510(k) submission:

Key Takeaway: The K083398 submission for CERCOM Cement is a 510(k) premarket notification, which relies on demonstrating substantial equivalence to legally marketed predicate devices, rather than presenting a performance study with detailed acceptance criteria for a novel device. Therefore, much of the requested information regarding specific performance studies, sample sizes, expert ground truth, and comparative effectiveness studies is not applicable to this type of submission.

Acceptance Criteria and Reported Device Performance

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Not Explicitly Stated for Performance)	Reported Device Performance (Summary of Equivalence)
Substantial equivalence to predicate devices in:	- Design
- Design	- Composition
- Composition	- Intended Use
- Intended Use	- Effectiveness
- Effectiveness	- Performance (implied as equivalent)
- Performance

Explanation: The FDA's 510(k) clearance process for CERCOM Cement is based on demonstrating "substantial equivalence" to existing, legally marketed predicate devices. This means that the acceptance criteria are not specific performance metrics against a predefined threshold, but rather a demonstration that the new device is as safe and effective as the predicate devices, and does not raise new questions of safety and effectiveness.

Study Details (Where Applicable for a 510(k) Submission)

Given that this is a 510(k) submission based on substantial equivalence, the following points address the questions in that context:

2. Sample size used for the test set and the data provenance:

Not applicable for a performance study. The submission does not describe a "test set" in the context of a prospective clinical study or a retrospective data analysis designed to measure performance against specific metrics. The "testing" involved would primarily be bench testing to confirm material properties and mechanical performance, and potentially comparison of properties to predicate devices, but without specific clinical test sets often associated with AI/software devices. The document does not provide details on such bench tests or data provenance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. There is no "test set" and thus no ground truth established by experts in the context of evaluating device performance for this 510(k) submission.

4. Adjudication method for the test set:

Not applicable. No test set requiring expert adjudication is described.

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:

Not applicable. This device is a dental cement, not an AI software or diagnostic imaging device that would involve human readers or AI assistance.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Not applicable. This device is a physical dental cement, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Not applicable. For a material device like dental cement in a 510(k), "ground truth" typically refers to established material science properties (e.g., bond strength, solubility, cure time) that are compared against industry standards or the properties of predicate devices. The document does not detail specific "ground truth" methodologies beyond stating equivalence to predicate devices.

8. The sample size for the training set:

Not applicable. There is no "training set" as this is not an algorithm or AI device.

9. How the ground truth for the training set was established:

Not applicable. There is no "training set" or explicit ground truth establishment described for this type of device submission.

Summary of the 510(k) Approach for CERCOM Cement:

The 510(k) for CERCOM Cement follows a common path for medical devices, particularly those that are materials or instruments with well-understood mechanisms of action. Instead of presenting new clinical performance studies, the manufacturer (Denali R&D Corporation) demonstrates that CERCOM Cement is "substantially equivalent" to several already-cleared predicate devices (RelyX Cement, Variolink Cement, Calibra Cement, Nexus Cement) in terms of:

Design: How it's formulated or structured.
Composition: The components it's made from.
Intended Use: The purpose for which it's marketed (bonding ceramic and composite restorations).
Effectiveness: Its ability to achieve its intended purpose.
Performance: Its functional characteristics.

The FDA's review confirms that this claim of substantial equivalence is valid, implying that the safety and effectiveness of CERCOM Cement are comparable to those established for the predicate devices. The absence of detailed clinical study data, expert panels, or AI-related metrics is therefore expected and appropriate for this type of submission.

Summary

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K08 3398

SUMMARY OF SAFETY AND E-FFECTIVENESS DATA

Dr Jan G Stannard 134 Old Washington Street Hanover, MA 02339-1629

DEVICE

Trade Name CERCOM Cement Classification Name Cement, Dental FDA Product Code 872 3275

781-826-9190 Telephone Fax 781-826-9190 | stannard@comcast net

JAN 2 6 2009

PREDICATE DEVICES RelyX Cement, ESPE/3M Variolink Cement, Ivoclar Calibra Cement, Dentsply Nexus Cement, Kerr

DESCRIPTION AND INTENDED USE

CERCOM Cement is a self-adhesive cement recommended for the bonding of ceramic and composite restorations

COMPARISON WITH PREDICATE PRODUCTS

CERCOM Cement is substantially equivalent in design, composition and intended use to the products listed above

SAFETY AND EFFECTIVENESS

CERCOM Cement is substantially equivalent in design, composition, performance, intended use and effectiveness to the predicate cement products listed above

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

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Dr Jan G Stannard President Denalı R&D Corporation 134 Old Washington Street Hanover, Massachusetts 02339-1629

JAN 2 6 2009

Re K083398 Trade/Device Name CERCOM Cement Regulation Number 21 CFR 872 3275 Regulation Name Dental Cement Regulatory Class II Product Code EMA Dated November 12, 2008 Received November 17, 2008

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls Existing major regulations affectung 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 - Dr Stannard

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), 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

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits vour device to proceed to the market

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801). please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115 Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807 97) For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474 For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464 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 (240) 276-3150 or at its Internet address http //www fda gov/cdrh/industry/support/index html

Sincerely yours,

Anthony D. Austin for
Ginette Y Michaud, M D

Acting 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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INDICATIONS FOR UST: STATEMENT

510 (k) Number _______________________________________________________________________________________________________________________________________________________________ (if known)

Device Name

CERCOM Cement

4683398

Indications for Use:

CERCOM Cement is a self-adhesive cement recommended for the bonding of ceramic and composite restorations

Please do not write below this line Conlinue on another page if needed

Concurrence of CDRH, Office of Device Evaluation (ODE)
signature
(Division Sign-Off)
Division of Anesthesiology, General Hospital
Infection Control, Dental Devices

510(k) Number:	K08 3398
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Prescription Use(Per 21 CFR 801 109)	or	Over-The-Counter Use
------------------------------------------	----	----------------------

Regulation Number and Section

§ 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.