ADAPTABLE COMPOSITE RESIN RESTORATIVE MATERIAL

K083841 · Dentsply International, Inc. · EBF · Apr 14, 2009 · Dental

Device Facts

• Record ID: K083841
• Device Name: ADAPTABLE COMPOSITE RESIN RESTORATIVE MATERIAL
• Applicant: Dentsply International, Inc.
• Product Code: EBF · Dental
• Decision Date: Apr 14, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3690
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Adaptable Composite Resin Restorative Material is indicated for the following procedures: 1. Indications with tooth/restorative interface - Class III and V restorations - Conservative Class I restorations - Small Class IV repairs - Tunnel Preparations - Filling of defects and undercuts in crown, inlay and onlay preparations - Blockouts - As a liner under direct restorative materials and under inlay restorations Class II box liner - As a base or liner for cavity Class I and II restorations - Repair of small enamel defects - Covering incisal edge stains - Pit and fissure sealant 2. Indications including tooth/indirect restorative materials - Cementing porcelain veneers, crowns, inlay and onlays - Intraoral porcelain repair - 3. Amalgam margin repair - 4. Provisional or Indirect Laboratory Indications: - Improving margins of acrylic temporaries - Provisional occlusal changes - Refacing acrylic temporaries - Margin correction/adjustment of composite crowns for indirect laboratory use

Device Story

Adaptable Composite Resin Restorative Material is a one-component, fluoride-containing, visible light-cured, radiopaque resin composite. Used by dentists in clinical settings for various restorative and prosthetic procedures, including cavity filling, lining, and cementation. The material is applied to the tooth or restorative interface and cured via visible light. It functions as a restorative, base, liner, or cement. The primary clinical benefit is the restoration of tooth structure and repair of dental materials with low shrinkage stress. The clinician uses the material to fill defects, block out undercuts, or adjust margins, directly impacting the structural integrity and aesthetics of the dental restoration.

Clinical Evidence

No clinical data. Evidence consists of biocompatibility testing (ISO 10993-1, ISO 7405) and in-vitro bench testing demonstrating compliance with ISO 4049 standards for polymer-based restorative materials.

Technological Characteristics

One-component, fluoride-containing, visible light-cured, radiopaque resin composite. Complies with ISO 4049 for polymer-based restorative materials. Biocompatibility verified per ISO 10993-1 and ISO 7405. Characterized by low shrinkage stress.

Indications for Use

Indicated for dental patients requiring Class I, III, IV, and V restorations, cavity base/liner, pit and fissure sealant, porcelain veneer/crown/inlay/onlay cementation, intraoral porcelain repair, amalgam margin repair, and laboratory-based provisional/indirect restorative adjustments.

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.

Predicate Devices

• Quixx Posterior Restorative (K040144)
• Flowable Composite (K981965)

Submission Summary (Full Text)

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# 510(k) SUMMARY for Adaptable Composite Resin Restorative Material

#### 1. Submitter Information:

DENTSPLY International Susquehanna Commerce Center 221 West Philadelphia Street York, PA 17405

| Contact Person: | Helen Lewis |
|-------------------|--------------|
| Telephone Number: | 717-849-4229 |
| Fax Number: | 717-849-4343 |

December 19, 2008 Date Prepared:

- 2. Device Name:
- Proprietary Name: .
- Classification Name: .
- CFR Number: .
- Device Class: .
- Product Code: EBF .

#### 3. Predicate Device:

| Company | Device | 510(k) Number | Date Cleared |
|---------------------------|-----------------------------|---------------|--------------|
| DENTSPLY<br>International | Quixx Posterior Restorative | K040144 | 04/01/2004 |
| | Flowable Composite | K981965 | 07/10/1998 |

872.3690

II

Adaptable Composite Resin Restorative Material

Tooth Shade Resin Material

### Description of Device: 4.

The Adaptable Composite Resin Restorative Material is a one-component, fluoridecontaining, visible light cured, radiopaque resin composite restorative material.

#### 5. Indications for Use:

Adaptable Composite Resin Restorative Material is indicated for the following procedures:

- 1. Indications with tooth/restorative interface
- Class III and V restorations ●
- Conservative Class I restorations .
- Small Class IV repairs .
- Tunnel Preparations 0
- Filling of defects and undercuts in crown, inlay and onlay preparations .
- . Blockouts
- As a liner under direct restorative materials and under inlay restorations Class II . box liner

K083841 Adaptable Composite Resin Restorative Material б

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- As a base or liner for cavity Class I and II restorations .
- Repair of small enamel defects .
- Covering incisal edge stains .
- . Pit and fissure sealant

2. Indications including tooth/indirect restorative materials

- Cementing porcelain veneers, crowns, inlay and onlays .
- Intraoral porcelain repair .
- 3. Amalgam margin repair
- 4. Provisional or Indirect Laboratory Indications:
- Improving margins of acrylic temporaries .
- Provisional occlusal changes .
- Refacing acrylic temporaries .
- Margin correction/adjustment of composite crowns for indirect laboratory use .
- Description of Safety and Substantial Equivalence: ર.

Technological Characteristics.

The technological characteristics (i.e., chemical composition and device function) of Adaptable Composite Resin Restorative Material are similar to that of the predicate devices. One difference is that the Adaptable Composite Resin Restorative Material has significant low shrinkage stress.

# Non-Clinical Performance Data.

Standard biocompatibility tests were performed on the Adaptive Composite Resin Restorative Material. All tests were performed in accordance with ISO 10993-1 (Biological Evaluation for Medical Device-Part 1: Evaluation and Testing) and ISO 7405 (Dentistry-preclinical evaluation of biocompatibility of medical devices used on dentistry- Test methods for dental materials). The studies indicated that the Adaptive Composite Resin Restorative Material is biocompatible and safe for its intended use.

In-vitro bench tests were performed on the Adaptive Composite Resin Restorative Material. The results indicated that the Adaptive Composite Resin Restorative Material meets or exceeds the requirements of ISO 4049 (Dentistry-Polymerbased filing, restorative and luting materials) and safe for its intended use.

### Conclusion as to Substantial Equivalence

We believe that the prior use of the components of Adaptable Composite Resin Restorative Material in legally marketed devices, the performance data provided, and the biocompatibility data provided support the safety and effectiveness of Adaptable Composite Resin Restorative Material for the indicated uses.

K083841 Adaptable Composite Resin Restorative Material 7

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

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 or bird-like symbol with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the bird symbol.

### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# APR 1 4 2009

Ms. Helen Lewis Director, Corporate DENTSPLY International 221 West Philadelphia Street York, Pennsylvania 17405-0872

Re: K083841

Trade/Device Name: Adaptable Composite Resin Restorative Material Regulation Number: 21 CFR 872.3690 Regulatory Class: II. Product Code: EBF Dated: April 3, 2009 Received: April 8, 2009

Dear Ms. Helen Lewis:

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 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.

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Page 2- Ms. Helen Lewis

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. 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 contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

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/cdrh/industry/support/index.html.

Sincerely yours,

Susan Russo, DDS, MS

Susan Runner, D.D.S., M.A. Acting 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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# INDICATIONS FOR USE STATEMENT

K083841 510(k) Number (if known): Device Name: Adaptable Composite Resin Restorative Material Indications for Use:

Adaptable Composite Resin Restorative Material is indicated for the following procedures: 1. Indications with tooth/restorative interface

- · Class III and V restorations
- ·Conservative Class I restorations
- · Small Class IV repairs
- · Tunnel Preparations
- · Filling of defects and undercuts in crown, inlay and onlay preparations
- · Blockouts
- As a liner under direct restorative materials and under inlay restorations Class II box liner
- · As a base or liner for cavity Class I and II restorations
- ·Repair of small enamel defects
- ·Covering incisal edge stains
- ·Pit and fissure Sealant

2. Indications including tooth/indirect restorative materials

· Cementing porcelain veneers, crowns, inlays/onlays

- · Intraoral porcelain repair
- 3. Amalgam margin repair
- 4. Provisional or Indirect Laboratory Indications:
- · Improving margins of acrylic temporaries
- ·Provisional occlusal changes
- ·Refacing acrylic temporaries
- •Margin correction/adjustment of composite crowns for indirect laboratory use

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

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRR affice of Reyice Evaluation (ODE)

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

K083841 Adaptable Composite Resporative Materia