(173 days)
None
Not Found
No
The summary describes a simple paste for temporary tooth repair and contains no mention of AI, ML, image processing, or performance studies typically associated with AI/ML devices.
Yes
The device is intended to temporarily repair teeth with cavities and lost fillings, which is a form of therapy for dental issues.
No
Explanation: The device is indicated for temporary repair of teeth, not for diagnosing conditions.
No
The device is described as a "paste," which is a physical substance, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "consumer application to temporarily repair teeth with cavities and lost fillings and inlays." This is a direct application to the body (teeth) for a physical repair, not for testing a sample taken from the body to diagnose a condition.
- Device Description: It's described as a "paste," which aligns with a material applied directly to the teeth.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing a sample (blood, urine, tissue, etc.)
- Detecting or measuring substances in a sample
- Providing information for diagnosis, monitoring, or screening
IVDs are used to perform tests in vitro (outside the living body) on samples taken from the body. This device is applied in vivo (within the living body) to perform a physical repair.
N/A
Intended Use / 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.
Product codes
EMA
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
teeth
Indicated Patient Age Range
Not Found
Intended User / Care Setting
consumer
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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.
1
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
2
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) | ||
|---|---|---|
| -- | -------------------------------------------------------- | -- |
(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
X