(55 days)
Cement-It All Purpose product is intended for cementation of porcelain, resin and metal-based inlays, onlays, crowns, bridges and posts. The material is not recommended for use on veneer restorations.
The subject device is a self-etch adhesive resin cement in a catalyst/base paste formulation and is a dual cure luting agent. Due to its self-etching and adhering properties, Cement-It All Purpose does not require the use of an etchant, primer or adhesive. Device composition is approximately 65% filler by weight with filler particle size values less than 2 microns. As with other resin products manufactured by Pentron Clinical Technologies, LLC., the predominant filler for Cement-It All Purpose is a barium borosilicate glass. This filler type provides the subject device with the required strength and radiopacity features. Product is supplied within automix dual barrel syringes for ease of dispensing directly into the restorative site.
This exemption refers to a 510(k) premarket notification for a dental cement product. For such submissions, the acceptance criteria are generally established through a comparison to a legally marketed predicate device, demonstrating substantial equivalence rather than through a standalone study with specific performance metrics and acceptance criteria.
Therefore, the provided documents do not contain the typical information one would find for a study that proves a device meets specific, quantitative acceptance criteria through a clinical or performance study with statistical endpoints. Instead, the "study" demonstrating performance is the comparison to a predicate device, supported by laboratory testing to ensure physical and chemical properties are comparable and safe.
Here's an analysis based on the provided text, outlining what can be inferred and what is explicitly stated:
1. Table of Acceptance Criteria and Reported Device Performance
As mentioned, this document focuses on substantial equivalence rather than meeting specific quantitative acceptance criteria like those found in a clinical trial. The "acceptance criteria" here are implicitly that the new device performs "the same intended function" and has similar "safety and effectiveness" as the predicate device.
| Acceptance Criteria (Inferred from Substantial Equivalence to Predicate) | Reported Device Performance (Inferred/Stated) |
|---|---|
| Intended function for cementation of porcelain, resin, and metal-based inlays, onlays, crowns, bridges, and posts. | Performs the same intended function as its predicate device, MaxCem (K041474). |
| Not recommended for use on veneer restorations. | Not recommended for use on veneer restorations. |
| Dual cure luting agent. | Is a dual cure luting agent. |
| Self-etch adhesive resin cement. | Is a self-etch adhesive resin cement. |
| Does not require etchant, primer, or adhesive. | Due to self-etching and adhering properties, does not require the use of an etchant, primer, or adhesive. |
| Filler content, particle size, and type. | Approximately 65% filler by weight with particle sizes < 2 microns; predominant filler is barium borosilicate glass, providing required strength and radiopacity. |
| Safety and effectiveness. | A review for safety and effectiveness was performed and found not to have been affected. |
2. Sample size used for the test set and the data provenance
The document does not specify a sample size for a "test set" in the context of a clinical performance study. The evaluation for 510(k) clearance is primarily a comparison to a predicate device, often involving:
- Bench testing: To compare physical, chemical, and mechanical properties (e.g., bond strength, radiopacity, wear resistance, setting time). Sample sizes for these tests would be determined by standard test methods but are not provided.
- Biocompatibility testing: To ensure safety.
The data provenance is not explicitly stated as retrospective or prospective for a clinical study, as a full clinical study with human subjects requiring such categorization is typically not performed for dental cements seeking 510(k) clearance if substantial equivalence can be demonstrated through other means. The data would be generated from laboratory/bench testing and possibly literature reviews comparing the new device's properties to the predicate.
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 and not provided for this type of submission. "Ground truth" established by experts is typically relevant for diagnostic devices or AI-driven systems where human interpretation is a key component of performance. For a dental cement, "ground truth" would relate to its physical and chemical properties and its clinical performance as a bonding agent, which is assessed through standardized laboratory tests and comparison to established predicate devices.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable and not provided. Adjudication methods are relevant in studies where human readers/experts are evaluating outcomes or interpretations (e.g., radiology studies). For a dental cement, performance is assessed via objective measurements from laboratory tests.
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
This information is not applicable. This is a dental cement, not an AI-driven diagnostic or treatment planning system. Therefore, MRMC studies and "human readers improve with AI" are irrelevant to this device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. This is a physical dental cement product, not an algorithm or software. Therefore, "standalone" algorithm performance is not relevant.
7. The type of ground truth used
The "ground truth" for demonstrating substantial equivalence for this dental cement would be based on:
- Laboratory test results: Objective measurements of physical, chemical, and mechanical properties (e.g., flexural strength, compressive strength, wear characteristics, radiopacity, bond strength, setting time) compliant with relevant ISO or ADA standards.
- Biocompatibility testing: To ensure the material is non-toxic and compatible with the human body.
- Comparison to predicate device: The established performance and safety profile of the legally marketed predicate device (MaxCem, K041474).
8. The sample size for the training set
This information is not applicable. "Training set" refers to data used to train machine learning models. This is a physical dental cement, not an AI model.
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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cing dentistry one Innovation at a time."
MAY 10 2006
6.0 510(K) SUMMARY
Pentron Clinical Technologies, LLC, 68 North Plains Industrial Road Wallingford, CT 06492 Tel: 203-265-7397 Fax: 203-265-3074 Contact: Greg Moreau =============================================================================================================================================================================
Trade Name: Cement-It All Purpose Common Name: Dental resin cement Classification Name: Dental Cement, 21CFR 872.3275, EMA ==============================================================================================================================================================================
Cement-It All Purpose product performs the same intended function as its predicate device, MaxCem (reference K041474). Both devices are intended for cementation of porcelain, resin and metal-based inlays, onlays, crowns, bridges and posts. Both devices are not recommended for use on veneer restorations.
The subject device is a self-etch adhesive resin cement in a catalyst/base paste formulation and is a dual cure luting agent. Due to its self-etching and adhering properties, Cement-It All Purpose does not require the use of an etchant, primer or adhesive.
Device composition is approximately 65% filler by weight with filler particle size values less than 2 microns. As with other resin products manufactured by Pentron Clinical Technologies, LLC., the predominant filler for Cement-It All Purpose is a barium borosilicate glass. This filler type provides the subject device with the required strength and radiopacity features.
Product is supplied within automix dual barrel syringes for ease of dispensing directly into the restorative site.
A review for safety and effectiveness was performed and found not to have been affected.
510(k) Submission for Cement-It All Purpose
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 10 2006
Mr. Greg Moreau Director, Quality Systems Pentron Clinical Technologies, LLC 68 North Plains Industrial Road Wallingford, Connecticut 06492
Re: K060698
Trade/Device Name: Cement-It All Purpose Regulation Number: 21 CFR 872.3275(b) Regulation Name: Dental Cement Regulatory Class: II Product Code: EMA Dated: April 28, 2006 Received: May 03, 2006
Dear Mr. Moreau:
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 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 - Mr. Greg Moreau
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 your 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 Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Chu S. Lin, PhD
Chiu S. Lin, PhD 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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5.0 INDICATION FOR USE STATEMENT
510(k) NUMBER (if KNOWN):
DEVICE NAME: Cement-It All Purpose
INDICATION FOR USE:
Cement-It All Purpose product is intended for cementation of porcelain, resin and metal-based inlays, onlays, crowns, bridges and posts. The material is not recommended for use on veneer restorations.
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED.)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use (Per 21 CFR 801.109) | ✓ |
|---|---|
| --------------------------------------- | ----------------------------------------------------- |
OR
| Over-The-Counter-Use (Optional Format 1-2-96) | |
|---|---|
| ----------------------------------------------- | -- |
510(k) Submission for Cement-It All Purpose
(Signature Sign-Off)
Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
§ 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.