PRIME-DENT AUTOMIX DUAL CURE CORE BUILD UP MATERIAL

K022675 · Prime Dental Manufacturing, Inc. · EBF · Nov 7, 2002 · Dental

Device Facts

• Record ID: K022675
• Device Name: PRIME-DENT AUTOMIX DUAL CURE CORE BUILD UP MATERIAL
• Applicant: Prime Dental Manufacturing, Inc.
• Product Code: EBF · Dental
• Decision Date: Nov 7, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3690
• Device Class: Class 2

Intended Use

Prime-Dent® Automix Dual Cure Core Build Up Material principal use is a dental core build-up material either with adhesives or with pins or posts.

Device Story

Prime-Dent Automix Dual Cure Core Build-Up Material is a dental restorative resin used to reconstruct tooth structure for crown or bridge placement. The material is supplied in an automix delivery system, allowing for consistent mixing and application. It is a dual-cure system, meaning it can be light-cured or chemically cured, providing flexibility for the clinician during the build-up process. Used by dentists in a clinical setting, the material is applied to prepared teeth, often supported by pins or posts, to provide a stable foundation for subsequent prosthetic restorations. The dual-cure mechanism ensures polymerization in areas where light access may be limited, facilitating efficient clinical workflows and durable restorative outcomes.

Clinical Evidence

Bench testing only.

Technological Characteristics

Dual-cure resin-based dental material; automix delivery system; classified as a tooth shade resin material under 21 CFR 872.3690; product code EBF.

Indications for Use

Indicated for use as a dental core build-up material in conjunction with adhesives, pins, or posts for dental restorative procedures.

Regulatory Classification

Identification

Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.

Submission Summary (Full Text)

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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 and Human Services. The logo features a stylized eagle with three lines forming its body and wings. The eagle is facing right, and the lines give the impression of movement or flight. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.

City Health Service

00 Corporate Boulevaro Rockville MD 20850

## 7 2002 NOV

Mr. Rolando Marasigan V.P. of Manufacturing Prime Dental Manufacturing; Incorporated 3735 West Belmont Avenue Chicago, Illinois 60618

Re: K022675

Trade/Device Name: Prime-Dent® Automix Dual Cure Core Build-Up Material Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: II Product Code: EBF Dated: October 30, 2002 Received: November 11, 2002

Dear Mr. Marasigan:

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 vour 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.

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.

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## Page 2 - Mr. Rolando Marasigan

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 practicc 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Timothy A. Ulatowski 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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Page 1 of 1

510(k) Number (if known):

Device Name: Prime-Dent Automix Dual Cure Core Build Up Material

·

and the comments of the

1022675

Indications For Use:

Prime-Dent® Automix Dual Cure Core Build Up Material principal use is a dental core build-up material either with adhesives or with pins or posts.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use <span style="text-decoration: overline;">✓</span> | OR | Over-The-Counter Use |
|--------------------------------------------------------------------|----|--------------------------|
| (Per 21 CFR 801.109) | | (Optional Format 1-2-96) |

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

| 510(k) Number | 2002675 |
|---------------|---------|
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