K Number
K031212
Device Name
TEMPORARY RESIN CEMENT
Manufacturer
Date Cleared
2003-07-11

(85 days)

Product Code
Regulation Number
872.3275
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
A radiopaque, self-cure, resin-based temporary cement that is used to lute provisional restorations such as crowns, inlays, onlays, fixed bridges, laminate veneers, etc. or to temporarily cement permanent dental restorations. A resin-based cement designed for use with provisional restorations such as crowns, inlays, fixed bridges, etc. or for temporary cementation of permanent restorations.
Device Description
A radiopaque, self-cure, resin-based temporary cement
More Information

TempBond Clear, Sensitemp, GC Temporary Cement

Not Found

No
The summary describes a dental cement and does not mention any AI or ML capabilities.

No.
The device is a temporary dental cement used for luting provisional and permanent dental restorations, which is a structural and adhesive function rather than a therapeutic one.

No
The device is described as a temporary cement used to lute provisional or temporary dental restorations, not to diagnose any condition.

No

The device description clearly states it is a "radiopaque, self-cure, resin-based temporary cement," which is a physical material, not software.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use clearly states that the device is a temporary cement used to lute (bond) dental restorations. This is a direct application within the body (or on a part of the body, like teeth) for a structural purpose.
  • Device Description: The description confirms it's a resin-based temporary cement.
  • Lack of IVD Characteristics: There is no mention of the device being used to examine specimens in vitro (outside the body) to provide information about a physiological state, health, or disease. IVDs typically involve analyzing samples like blood, urine, tissue, etc.

Therefore, this device falls under the category of a dental device used for restorative purposes, not an in vitro diagnostic device.

N/A

Intended Use / Indications for Use

A radiopaque, self-cure, resin-based temporary cement that is used to lute provisional restorations such as crowns, inlays, onlays, fixed bridges, laminate veneers, etc. or to temporarily cement permanent dental restorations.
A resin-based cement designed for use with provisional restorations such as crowns, inlays, fixed bridges, etc. or for temporary cementation of permanent restorations.

Product codes

EMA

Device Description

A radiopaque, self-cure, resin-based temporary cement

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

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)

TempBond Clear, Sensitemp, GC Temporary Cement.

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

JUL 1 1 2003

최고 대표 사

K031212

510(k) SUMMARY

| Submitter: | Parkell, Inc.
155 Schmitt Blvd.
Box 376
Farmingdale, NY 11735
TEL: 631-249-1134
FAX: 631-249-1242 |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Nelson J. Gendusa, DDS
Director of Research
Parkell
155 Schmitt Blvd.
Box 376
Farmingdale, NY 11735 |
| Submission Date: | 15 April 2003 |
| Trade Name: | Currently Not Available |
| Common Name: | Temporary Cement |
| Classification Name: | Cement, Dental (other than zinc oxide-eugenol) |
| Equivalence: | TempBond Clear, Sensitemp, GC Temporary Cement. |
| Description/Intended Use: | A radiopaque, self-cure, resin-based temporary cement
that is used to lute provisional restorations such as
crowns, inlays, onlays, fixed bridges, laminate veneers,
etc. or to temporarily cement permanent dental
restorations. |

:

1

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles an abstract caduceus or a series of flowing lines.

Public Health Service

JUL 1 1 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Nelson J. Gendusa, DDS Director of Research Parkell, Inccorporated 155 Schmitt Boulevard P.O. Box 376 Farmingdale, New York 11735

Re: K031212

Trade/Device Name: Temporary Resin Cement Regulation Number: 21 CFR 872.3275(b) Regulation Name: Dental Cement Regulatory Class: II Product Codes: EMA Dated: April 15, 2003 Received: April 17, 2003

Dear Dr. Gendusa:

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.

2

Page 2 - Nelson J. Gendusa, DDS

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 (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 may be obtained 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/dsma/dsmamain.html

Sincerely yours,

Susan Rinne/

Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital. Infection Control and Dental Devices Office of Device Evaluation ' Center for Devices and Radiological Health

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Page ___ of ___ of ___________________________________________________________________________________________________________________________________________________________

510(k) Number (if known):_
TEMPORARY RESIN CEMENT (12-9-1/2)
Device Name:
Indications for Use:A resin-based cement designed for use with provisional restorations such as crowns, inlays,
fixed bridges, etc. or for temporary cementation of permanent restorations.
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Son MSG7
(Division Sign-Off)
Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices
K 031212
510(k) Number: __

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