COMPOSITE/COMPOMER REPAIR KIT

K041960 · Dmg USA, Inc. · KLE · Aug 30, 2004 · Dental

Device Facts

• Record ID: K041960
• Device Name: COMPOSITE/COMPOMER REPAIR KIT
• Applicant: Dmg USA, Inc.
• Product Code: KLE · Dental
• Decision Date: Aug 30, 2004
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 872.3200
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The Composite/Compomer Repair Kit consists of 4 materials: 1. a general 6th generation bonding agent for enamel and dentin, 2. a special bonding agent for resin-based materials in general, i. e. composites, compomers, and ormocers, 3. a flowable compomer and 4. a flowable composite Bonding System (Contax) is indicated for bonding chemically cured, light cured, or dual cured resin-based materials e. g. composite, compomer, ormocer materials to tooth structure (dentin and enamel) treatment of hypersensitive teeth . Composite Repair MMA-free is indicated as a bonding agent for the intra- or extraoral repair of poor or damaged resin-based materials restorations as a bonding agent for composite-based posts . for shade corrections of esthetically unsatisfying restorations . for repair and completion of temporary crowns and bridges . as a bonding agent on resin-based materials . PrimaFlow is indicated for minimally invasive restorations . Class III and V restorations . bases . extended fissure sealing . restorations of all classes of cavities in deciduous teeth . as a temporary luting cement for e.g. veneers, and . as a flowable compomer repair agent . Flowable Composite (LuxaFlow) is indicated as as an aesthetic anterior restoration . a base restoration under posterior or anterior composites . an add-on or repair material for provisional crowns & bridges . for incorporation of most mechanically anchored attachment components into the acrylic base of an overdenture or partial denture. as a temporary luting cement for e.g. veneers, and . as a flowable composite repair agent .

Device Story

Kit comprises four dental materials: 6th generation bonding agent, resin-specific bonding agent, flowable compomer, and flowable composite. Used by dentists in clinical settings for restorative dentistry. Materials applied to tooth structure or existing restorations to bond, repair, or fill cavities. Bonding agents facilitate adhesion of resin-based materials (composites, compomers, ormocers) to dentin/enamel or existing restorations. Flowable components serve as restorative materials, bases, or luting cements. Clinical benefit includes restoration of tooth function/aesthetics, repair of damaged restorations, and hypersensitivity management.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Kit includes 6th generation bonding agent, resin-specific bonding agent, flowable compomer, and flowable composite. Materials are chemically, light, or dual-cured. Designed for dental restorative applications. No specific ASTM standards or software algorithms described.

Indications for Use

Indicated for dental patients requiring restorative procedures, including cavity restorations (all classes in deciduous teeth, Class III/V in permanent), repair of damaged resin-based restorations, shade correction, temporary crown/bridge completion, bonding of composite posts, luting of veneers, and treatment of hypersensitive teeth.

Regulatory Classification

Identification

A resin tooth bonding agent is a device material, such as methylmethacrylate, intended to be painted on the interior of a prepared cavity of a tooth to improve retention of a restoration, such as a filling.

Predicate Devices

• PrimaFlow (K002086)
• Zenith Flowable Composite (K970683)
• Composite Repair (K992879)
• Clearfill Repair (K001914)
• PermaCem (K012316)
• LuxaCore/uxaCore Dual (K012307)
• Solobond Plus (K003153)
• Tag Bong (K845033)
• Xeno III (K023776)
• iBond (K022612)

Submission Summary (Full Text)

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# 04196

#### AUG 3 0 2004 Attachment K 510(k) Summary

| Trade Name: | Composite/Compomer Repair Kit |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------|
| Sponsor: | DMG USA, Inc.<br>414 South State Street<br>Dover, DE 19901<br>Registration # not yet assigned<br>Owner/Operator No. 9005969 |
| Device Generic Name: | Dental restorative material and bonding agent |
| Classification: | According to Section 513 of the Federal Food, Drug, and<br>Cosmetic Act, the device classification is Class II. |

#### Predicate Devices:

The proposed DMG-USA Composite/CompomerKit restorative material is substantially equivalent to several currently marketed dental restorative materials:

| Product Name | 510(k) # | Manufacturer |
|---------------------------|----------|----------------------|
| PrimaFlow | K002086 | DMG USA |
| Zenith Flowable Composite | K970683 | Foremost Dental Mfg. |
| Composite Repair | K992879 | DMG-Hamburg |
| Clearfill Repair | K001914 | Kuraray Co., Ltd. |
| PermaCem | K012316 | DMG USA |
| LuxaCore/uxaCore Dual | K012307 | DMG USA |
| Solobond Plus | K003153 | Voco |
| Tag Bong | K845033 | Foremost Dental Mfg. |
| Xeno III | K023776 | Dentsply |
| iBond | K022612 | Heraeus Kulzer |

# Product Description/Indications for Use:

The Composite/Compomer Repair Kit consists of 4 materials:

- 1. A general 6" generation bonding agent for enamel and dentin,
- 2. A special bonding agent for resin-based materials in general, i. e. composites, compomers, and ormocers,
- 3. A flowable compomer and
- 4. A flowable composite

Bonding System is indicated for

- . bonding chemically cured, light cured, or dual cured resin-based materials e. g. composite, compomer, ormocer materials to tooth structure (dentin and enamel)
- treatment of hypersensitive teeth .

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# Composite Repair MMA-free is indicated

- as a bonding agent for the intraoral repair of poor or damaged resin-based . materials composite restorations
- . as a bonding agent for composite-based posts
- . for shade corrections of esthetically unsatisfying restorations
- for repair and completion of temporary crowns and bridges .
- . as a bonding agent on resin-based materials

#### PrimaFlow is indicated for

- minimally invasive restorations .
- Class III and V restorations
- . bases
- . extended fissure sealing
- restorations of all classes of cavities in deciduous teeth .
- as a temporary luting cement for e.g. veneers, and .
- . as a flowable compomer repair agent .

#### Flowable Composite is indicated as

- as an aesthetic anterior restoration .
- a base restoration under posterior or anterior composites .
- . an add-on or repair material for provisional crowns & bridges
- . for incorporation of most mechanically anchored attachment components into the acrylic base of an overdenture or partial denture.
- . as a temporary luting cement for e.q. veneers, and
- . as a flowable composite repair agent .

#### 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 quidance document entitled Guidance for Industry and FDA Staff: Dental Composites -Premarket Notification (November 1998).

#### Conclusion:

Based on the indications for use, technological characteristics, and comparison to the predicate devices, the Composite/Compomer Repair Kit restorative materials have been shown to be safe and effective for its intended use.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes representing the three levels of government: federal, state, and local. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 3 0 2004

Ms. Pamela Papineau, RAC Consultant DMG USA, Incorporated 414 South State Street Dover, Delaware 19901

Re: K041960

Trade/Device Name: Composite/Compomer Repair Kit Regulation Number: 21 CFR 872.3200 Regulation Name: Resin Tooth Bonding Agent Regulatory Class: II Product Codes: KLE and EBF Dated: June 15, 2004 Received: July 21, 2004

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.

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.

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# Page 2 – Ms. Pamela Papineau, RAC

Please be advised that FDA's issuance of a substantial equivalence determination does not mean r loase be advisod that 1 27 × ination that your device complies with other requirements of the Act or that I Dri has mude a acternilations 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); an the Act 3 requirements) increased and manufacturing practice requirements as set forth in the quality fabething (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) rins letter will acation. The FDA finding of substantial equivalence of your device to a legally premaince notification - 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 rr you active of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, andraa votabling ogy and in
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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

"Chiu S. Lin, PhD 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 of

510(k) Number (if known): K041960

Device Name: Composite/Compomer Repair Kit

### Indications for Use:

The Composite/Compomer Repair Kit consists of 4 materials:

- 1. a general 6th generation bonding agent for enamel and dentin,
- 2. a special bonding agent for resin-based materials in general, i. e. composites, compomers, and ormocers,
- 3. a flowable compomer and
- 4. a flowable composite

# Bonding System (Contax) is indicated for

- bonding chemically cured, light cured, or dual cured resin-based . materials e. g. composite, compomer, ormocer materials to tooth structure (dentin and enamel)
- treatment of hypersensitive teeth .

# Composite Repair MMA-free is indicated

- as a bonding agent for the intra- or extraoral repair of poor or damaged . resin-based materials restorations
- as a bonding agent for composite-based posts .
- for shade corrections of esthetically unsatisfying restorations .
- for repair and completion of temporary crowns and bridges .
- as a bonding agent on resin-based materials .

PrimaFlow is indicated for

- minimally invasive restorations �
- Class III and V restorations .
- bases .
- extended fissure sealing ●
- restorations of all classes of cavities in deciduous teeth .
- as a temporary luting cement for e.g. veneers, and .
- as a flowable compomer repair agent .

2 Page of

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# Flowable Composite (LuxaFlow) is indicated as

- as an aesthetic anterior restoration .
- a base restoration under posterior or anterior composites .
- an add-on or repair material for provisional crowns & bridges .
- for incorporation of most mechanically anchored attachment . components into the acrylic base of an overdenture or partial denture.
- as a temporary luting cement for e.g. veneers, and .
- as a flowable composite repair agent . .

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-the -Counter Use (21 CFR 807 Subpart D)

Suresh Kumar

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

510(k) Number. K941640