SELF ADHESIVE COMPOSITE LUTING CEMENT

K093338 · Dmg USA, Inc. · EMA · Feb 12, 2010 · Dental

Device Facts

• Record ID: K093338
• Device Name: SELF ADHESIVE COMPOSITE LUTING CEMENT
• Applicant: Dmg USA, Inc.
• Product Code: EMA · Dental
• Decision Date: Feb 12, 2010
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 872.3275
• Device Class: Class 2

Intended Use

The Self adhesive composite luting cement is indicated for the adhesive fixing of ceramic, composite and metal-based inlays, onlays, crowns, bridges and posts, screws, veneers and orthodontic appliances.

Device Story

Universal, dual-curing, self-adhesive composite luting cement; used by dental professionals for permanent cementation of various dental restorations (inlays, onlays, crowns, bridges, posts, screws, veneers, orthodontic appliances). Material applied to restoration or tooth surface to provide adhesive bond. Dual-curing mechanism allows for both light-cure and self-cure polymerization. Benefits include simplified clinical procedure by eliminating separate etching or bonding steps. Used in clinical dental settings.

Clinical Evidence

Bench testing only. Conformity demonstrated via adherence to FDA guidance documents for Dental Cements (1998) and Dental Composite Resin Devices (2005), and compliance with ISO 4049 (Polymer-based restorative/luting materials) and ISO 7405 (Biocompatibility).

Technological Characteristics

Dual-curing, polymer-based composite luting cement. Complies with ISO 4049:2000 (Polymer-based Filling, Restorative and Luting materials) and ISO 7405:1997 (Biocompatibility).

Indications for Use

Indicated for adhesive fixation of ceramic, composite, and metal-based dental restorations including inlays, onlays, crowns, bridges, posts, screws, veneers, and orthodontic appliances.

Regulatory Classification

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. 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.

Predicate Devices

• Unicem (K072973)
• Maxcem (K041474)

Submission Summary (Full Text)

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Kog3338

# 510(k) Summary

| Trade Name: | Self adhesive composite luting cement | |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------|-------------|
| Sponsor: | DMG USA, Inc.<br>23 Frank Mossberg Drive<br>Attleboro, MA 02703<br>Registration # not yet assigned<br>Owner/Operator No. 9005969 | FEB 12 2010 |
| Device Generic Name: | Self adhesive composite luting cement | |
| Classification: | According to Section 513 of the Federal Food, Drug, and<br>Cosmetic Act, the device classification is Class II. | |

#### Product Description

Self adhesive composite luting cement is a universal, self adhesive, dual-curing composite luting cement.

#### Indications for Use:

The Self adhesive composite luting cement is indicated for the adhesive fixing of ceramic, composite and metal-based inlays, onlays, crowns, bridges and posts, screws, veneers and orthodontic appliances.

#### Device Description:

The Self adhesive composite luting cement is a dental cement that complies with the requirements set forth in the following standards:

- ISO 7405:1997 Dentistry Preclinical evaluation of biocompatibility of medical . devices used in dentistry - Test methods for dental materials
- ISO 4049: 2000; Dentistry Polymer-based Filling, Restorative and Luting materials .

#### Predicate Devices:

The components of the proposed Self adhesive composite luting cement are substantially equivalent to several currently marketed dental cements including the following:

### Self adhesive composite luting cement:

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|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Jnicem | KOR7297<br>3M | |
| Maxcem | K041474 (Sybron Dental Specialties, inc.<br>I | |

#### Safety and Performance:

This submission is an Abbreviated 510(k) as described in FDA's guidance document entitled "The New 510(k) Paradigm - Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications." In support of this 510(k), DMG-USA has provided information to demonstrate conformity with FDA's guidance document entitled Guidance for Industry and FDA Staff: Dental Cements - Premarket Notification (August 1998) and Guidance for Industry and FDA Staff: Dental Composite Resin Devices -Premarket Notification [510(k)] Submissions (October 2005).

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# Conclusion:

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Based on the indications for use, technological characteristics, and comparison to the predicate devices, the Self adhesive composite luting cement has been shown to be safe and effective for its intended use.

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

FEB 1 2 2010

DMG USA, Incorporated C/O Ms. Pamela Papineau Delphi Medical Device Consulting 5 Whitcomb Avenue Aver, Massachusetts 01432

Re: K093338

Trade/Device Names: Self Adhesive Composite Luting Cement Regulation Number: 21 CFR 872.3275 Regulation Name: Dental Cement Regulatory Class: II Product Code: EMA Dated: January 22, 2010 Received: January 27, 2010

Dear Ms. Papineau:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 - Ms. Papineau

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act 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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

for

Anthony D. Watson, B.S., M.S., M.B.A. 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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510(k) Number (if known): ___K093338

Device Name: Self adhesive composite luting cement

# Product Indications for Use:

Self adhesive composite luting cement is a universal, self adhesive, dual-curing composite luting cement.

The Self adhesive composite luting cement is indicated for the adhesive fixing of ceramic, composite and metal-based inlays, onlays, crowns, bridges and posts, screws, veneers and orthodontic appliances.

OR Prescription Use X (Per 21 CFR 801 Subpart D)

Over-the -Counter Use (Per 21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Kevin M. So, MSR

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

510(k) Number: K093398