TEMP F by NOVOCOL, INC. | FDA 510(k) Summary

Temp F is indicated for the following applications: Temp F is a paste for consumer application to temporarily repair teeth with cavities and lost fillings and inlays.

Device Description

Temp F is a paste

AI/ML Overview

This is an FDA 510(k) clearance letter for a dental cement called "Temp F". The document states that the device is "substantially equivalent" to legally marketed predicate devices. However, this type of document does not contain the detailed study information or acceptance criteria typically found in a clinical study report or a premarket approval (PMA) application.

Therefore, I cannot provide the requested information about acceptance criteria, device performance, sample sizes, ground truth establishment, or study designs (MRMC, standalone) based solely on the provided text. The 510(k) pathway for medical device clearance primarily focuses on demonstrating substantial equivalence to a predicate device, rather than requiring extensive clinical trials with pre-defined acceptance criteria and detailed performance reporting as would be expected for novel or higher-risk devices.

Here's what I can extract and what I cannot, based on the provided text:

Information I CAN provide:

Trade/Device Name: Temp F
Regulation Number: 872.3275
Regulation Name: Dental Cement
Regulatory Class: II
Product Code: EMA
Indications for Use: Temp F is a paste for consumer application to temporarily repair teeth with cavities and lost fillings and inlays.
510(k) Number: K040343
Use Type: Over-The-Counter Use (X marked)

Information I CANNOT provide from the given document:

A table of acceptance criteria and the reported device performance: This document confirms substantial equivalence but does not detail specific performance metrics, acceptance criteria, or a table comparing them to reported results.
Sample sizes used for the test set and the data provenance: Not mentioned in this clearance letter.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable or mentioned as this is not a study report.
Adjudication method for the test set: Not applicable or mentioned.
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 diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable or mentioned in this type of document.
The sample size for the training set: Not applicable or mentioned.
How the ground truth for the training set was established: Not applicable or mentioned.

To obtain the detailed study information, acceptance criteria, and performance data, one would typically need to review the full 510(k) submission summary (if available publicly) or the actual studies referenced within the submission, which are not part of this clearance letter.

Summary

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows a circular seal with an emblem in the center. The emblem is a stylized depiction of an eagle or bird with three wing-like shapes. Encircling the emblem is text, which appears to read "DEPARTMENT OF HEALTH & HUMAN SERVICES, USA".

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG - 3 2004

Novocol, Corporation C/O Mr. Stephen Rudolph Confi-Dental Products, Company 416 South Taylor Avenue Louisville, Colorado 80027

Re: K040343

Trade/Device Name: Temp F Regulation Number: 872.3275 Regulation Name: Dental Cement Regulatory Class: II Product Code: EMA Dated: May 18, 2004 Received: May 26, 2004

Dear Mr. Rudolph:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your sectermined 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 mendments, 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 the Federal F 60d, Drag, and Soou may, therefore, market the device, subject to the general approvin application (she Act. The general controls provisions of the Act include controls provisions 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 (1 wr (), it may of 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 Eederal Register.

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Page 2 - Mr. Rudolph

Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that 1 DX 3 issualles or that your device complies with other requirements mean that I DA has made a decembers and regulations administered by other Federal agencies. 01 the Act of ally I ederal barates and squirements, including, but not limited to: registration Tourinust comply with an all the Provential Class Part 801); good manufacturing practice allu listing (21 CF R Part 807), labelity systems (QS) regulation (21 CFR Part 820); and if requirenches as set form in the quality signify on tontrol 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 anow you to oegn madically your substantial equivalence of your device to a premiteted 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), If you desire specific advice to: Joan de at (301) 594-4613. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the may obtain 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/dsma/dsmamain.html

Sincerely yours,

Ching-Lin, Ph.D.

Chiu Lin, Ph.D. 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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Verl 3 - 4/24/96

Applicant:	Confi-Dental Products Company
510K number (if known):	K040343

Device Name: Temp F

Indications for Use:

Temp F is indicated for the following applications:

Temp F is a paste for consumer application to temporarily repair teeth with cavities and lost fillings and inlays.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

	Concurrence of CDRH, Office of Device Evaluation (ODE)
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(Per 21 CFR 801.109)

Angela Blackwell for NSR

(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices

510(k) Number: K040343

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.