(36 days)
Cementation of Gutta-Percha in root canal using the single cone technique.
Not Found
This document is a 510(k) clearance letter from the FDA for a dental cement, Premier EndoCem Glass Ionomer Cement, and does not contain the detailed study information typically found in a clinical study report or a premarket approval (PMA) application. Therefore, most of the requested information regarding acceptance criteria, device performance, study design, and ground truth establishment is not available in this document.
The primary purpose of this letter is to state that the FDA has determined the device is substantially equivalent to legally marketed predicate devices, allowing it to be marketed.
Here's what can be extracted, and what is explicitly not available:
1. A table of acceptance criteria and the reported device performance:
- Not available in this document. The FDA letter grants clearance based on "substantial equivalence" to a predicate device, meaning it performs as safely and effectively as a similar device already on the market. It does not provide specific performance metrics or acceptance criteria for a new study.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not available in this document. This letter does not describe any specific test set or study methodology.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not available in this document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not available in this document.
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 and not available. This device is a dental cement, not an AI-powered diagnostic tool. MRMC studies are used for evaluating diagnostic imaging systems with human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable and not available. Again, this is a physical dental cement, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not available in this document. If a comparison was made for substantial equivalence, it would likely involve in vitro testing or perhaps clinical data demonstrating similar mechanical properties, biocompatibility, or sealing capabilities to the predicate device. The exact "ground truth" for showing equivalence is not detailed here.
8. The sample size for the training set:
- Not applicable and not available. There is no mention of a "training set" as this is not an AI/machine learning device.
9. How the ground truth for the training set was established:
- Not applicable and not available.
Summary of available information related to the device:
- Device Name: Premier EndoCem Glass Ionomer Cement
- K Number: K042215
- Regulation Number: 21 CFR 872.3275(b)
- Regulation Name: Dental Cement
- Regulatory Class: II
- Product Code: EMA
- Indications for Use: Cementation of Gutta-Percha in root canal using the single cone technique.
To obtain the detailed information requested, one would typically need to review the original 510(k) submission (which is usually not publicly available in its entirety due to proprietary information) or a specific clinical study report if one was conducted and published. The FDA clearance letter itself is a summary of their decision, not the full scientific dossier.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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 abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 2 1 2004
Mr. Vince D'Alessandro Regulatory Manager Premier Dental Products Company 1710 Romano Drive Plymouth Meeting, Pennsylvania 19462
Re: K042215
Trade/Device Name: Premier EndoCem Glass Ionomer Cement Regulation Number: 21 CFR 872.3275(b) Regulation Name: Dental Cement Regulatory Class: II Product Code: EMA Dated: August 11, 2004 Received: August 16, 2004
Dear Mr. D'Alessandro:
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 arior 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. Vince D'Alessandro
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA 's Issuance of a substance or and other requirements of the Act or
that FDA has made a determination that your device attemption of our must comply that FDA has made a determination into your dee a compless. You must comply with
any Federal statutes and regulations administered by other Federal and listing (21 CFR Part 8 any Federal statutes and regulations administered by other resustation and listing (21 CFR Part 807);
all the Act's requirements, including, but not limited to: registration all the Act's requirements, Including proctice requirements as set forth in the quality
labeling (21 CFR Part 801); good manufacturing practice requirements as est orth in th labeling (21 CFR Part 801); good manufacturing interests absorbed the electronic product radiation
systems (QS) regulation (21 CFR Part 820); and if applicable, the electroni systems (QS) regulation (21 OFR 120086), Act); 21 CFR 1000-1050.
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) This letter will allow you to begin marketing your active of your device of your device to a legally
premarket notification. The FDA finding of substantial equivalence of th premarket notification. The FDA finding of substantial equilter of 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 If you desire specific advice for your device on our and the results on the promotions on the promotion
contact the Office of Compliance at (301) 594-4613. Additionally, for contact the Office of Compliance at (301) 594-4615 for and contact (301) 594-4639. Also,
and advertising of your device, please contact the Office of Compliance at (311 FFR and advertising of your device, prease comact as onemarket notification" (21CFR)
please note the regulation entitled, "Misbranding by references researchilities under the Act please note the regulation entitled, "Misuralion on your responsibilities under the Act may
Part 807.97) you may obtain. Other general information on Consumer Assistance any Part 807.97) you may obtain. Other getter informational Consumer Assistance at its
be obtained from the Division of Small Manufacturers, International Consumer Assistance at be obtained from the Dryiston or chiaon of chian its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Susan Runner
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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Statement of Indications for Use
510(k) Number (If known): __
Device Name: Premier Endo Cem
Indications for use: Cementation of Gutta-Percha in root canal using the single cone technique.
Please do not write below this line Concurrence of CDRH, Office of Device Evaluation (ODE)
OR Over-the-Counter Use Prescription Use Per 21 CFR 801.109
Optional Format 1-2-96
Sirsen Quorr
(Division Sign-Off) (Division Sign-On)
Division of Anesthesiclogy, General Hospital, Division Control, Dental Devices
Page 3-1
510(k) Number: Kauai15
§ 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.