CONFORM

K062157 · Apex Dental Materials, Inc. · EBF · Oct 13, 2006 · Dental

Device Facts

• Record ID: K062157
• Device Name: CONFORM
• Applicant: Apex Dental Materials, Inc.
• Product Code: EBF · Dental
• Decision Date: Oct 13, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3690
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

CONFORM™ is a light cured (free radical polymerization), flowable composite material, designed for use as a filling material for small restorations, a sealant material for occlusal surfaces, or a lining material in the base of large restorations. CONFORM™ is a versatile composite material which, when utilized properly, provides a strong, wear resistant material for dental restorations. CONFORM™ can also be used as the initial filled layer or liner of a cavity restoration. When used as a liner, the material provides a strong base that assures the mechanical interface between the bonded tooth substrate and a highly filled composite are optimal. CONFORM™ is compatible with all other methacrylate based dental materials.

Device Story

CONFORM™ is a light-cured, flowable hybrid composite material; methacrylate (BisGMA) based; contains inorganic fillers for strength and radiopacity. Used by dentists in clinical settings for small restorations, cavity lining, sealants, and repairs. Applied directly to bonded tooth surfaces; hardens via photo-initiated free radical polymerization using a light initiator and chemical activator. Thixotropic behavior facilitates placement. Provides a strong, wear-resistant interface between tooth substrate and restorative materials. Benefits include versatility in restorative applications and compatibility with existing methacrylate-based dental adhesives and composites.

Clinical Evidence

Bench testing only. Physical testing observations and analysis, including diametric tensile strength and compressive strength, were used to demonstrate substantial equivalence to predicate devices.

Technological Characteristics

Flowable hybrid composite; methacrylate (BisGMA) based; contains inorganic fillers. Light-cured (photo-initiated free radical polymerization). Thixotropic properties. Radiopaque. Compatible with methacrylate-based adhesives/composites.

Indications for Use

Indicated for dental patients requiring small restorations (Class III, IV, V), cavity lining, pit and fissure sealing, marginal defect repair, small core build-ups, porcelain repair, porcelain veneer cementation, and bonding splints.

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

• AELITEFLO® (K955292)
• PERMAFLO® (K974413)

Submission Summary (Full Text)

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OCT 1 3 2006

# 510 (K) SUMMARY

### As Required by the Safe Medical Devices Act of 1990

Apex Dental Materials, Inc. 23329 Mallard Court Deer Park, IL 60010 Phone: [phone]

July21st, 2006 510 (K) Submission Date: Chris Kulton Contact Person: Device Name: CONFORM™ Trade Name: Material, Tooth Shade, Resin Common Name: Tooth Shade Resin Material, per 21 CFR parts 872.3690 Classification Name: Classification: Regulatory Class: 2

### IDENTIFICATION OF THE LEGALLY MARKETED PREDICATE DEVICE

EBF

#### PREDICATE DEVICE

Product Code:

AELITEFLO® (Bisco, Inc. K955292) is a flowable composite material designed to act as a

cavity filling or lining material. This system is applied directly to bonded tooth surfaces to

effectively replace removed tooth structure.

AELITEFLO® (Bisco, Inc. K955292) is a methacrylate based composite material filled with

various inorganic glasses to provide strength, wear and radiopacity characteristics.

AELITEFLO® is a single paste material that is used directly with dental bonding systems. It

510K Submission for CONFORM™ Apex Dental Materials, 23329 Mallard Court Deer Park, IL 60010

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hardens by a photo initiated polymerization mechanism employing a light initiator, and a chemical activator.

Summary continued:

#### DESCRIPTION OF APPLICATION DEVICE

CONFORM™ is a light activate (photo initiated, free radical polymerization), flowable hybrid composite material designed to act as a filling material in small restorations or as a liner material for larger restorations. CONFORM™ has been designed to provide a flowable material with a high level of thixotropic behavior. The material also contains fillers to optimize the cured strength and radiopacity properties.

CONFORM™ is a methacrylate (BisGMA) based material that has been designed to work effectively with methacrylate based adhesives and composites currently sold into the dental market.

#### INTENDED USES OF APPLICANT DEVICE

CONFORM™ is a light-cured composite with flow characteristics that make it ideal for Class V restorations, as well as Class III, and small Class IV restorations. Other uses of this material are as a liner for Class I and II restorations, pit and fissure sealants, the repair of marginal defects, small core build-ups, porcelain repair, porcelain veneer cementation or as a flowable composite for bonding splints into place.

- Class V .
- Class III .
- Cavity Liner .

510K Submission for CONFORM™ Apex Dental Materials, 23329 Mallard Court Deer Park, IL 60010

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- Pit and Fissure sealant ●
- Porcelain repair .
- . Margin repair
- Core build ups .
- . Buccal repair

Summary continued:

### PERFORMANCE CHARACTERISTICS and CONCEPTS

CONFORM™ has similar handling to the AELITEFLO® (510K number K955292, Bisco, Inc.) composite. From the physical testing observations and analysis, including diametric tensile strength and compressive strength, we suggest that CONFORM™MM is substantially equivalent to AELITEFLO® (510K number K955292, Bisco, Inc.). Along with this we would suggest the individual components of CONFORM™ are long time industry standards and are utilized in numerous dental composite products currently marketed in the United States (see Confidential Formulation Details on page 5).

| Equivalent Product and Manufacturer | Corresponding 510(k) Number |
|-------------------------------------|-----------------------------|
| AELITEFLO® (Bisco, Inc.) | K955292 |
| PERMAFLO® (Ultradent Products Inc.) | K974413 |

510K Submission for CONFORM™ Apex Dental Materials, 23329 Mallard Court Deer Park, IL 60010

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0C1 1 3 2006

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Chris Kulton Apex Dental Materials, Incorporated 23329 Mallard Court Dear Park, Illinois 60010

Re: K062157

Trade/Device Name: ConformTM Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: II Product Code: EBF Dated: July 21, 2006 Received: July 31, 2006

Dear Mr. Kulton:

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 – Mr. Chris Kulton

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 [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). 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.

Scudette Y. Michelini Ond

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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## Indications for Use

510(K) Number (if known):

K062157

Device name:

CONFORMIM

Indications For Use:

CONFORM™ is a light cured (free radical polymerization), flowable composite material, designed for use as a filling material for small restorations, a sealant material for occlusal surfaces, or a lining material in the base of large restorations.

CONFORM™ is a versatile composite material which, when utilized properly, provides a strong, wear resistant material for dental restorations. CONFORM™ can also be used as the initial filled layer or liner of a cavity restoration. When used as a liner, the material provides a strong base that assures the mechanical interface between the bonded tooth substrate and a highly filled composite are optimal. CONFORM™ is compatible with all other methacrylate based dental materials.

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

Concurrence of CDRL, Office of Device Evaluation (ODE)

| | <img alt="Signature" src="signature.png"/> |
|----------------------------------------|-----------------------------------------------------------------|
| Prescription use X (Per 21 CFR 801.109 | OR |
| | ion of Anesthesiology, General Hospital, Over, The- Counter Use |
| | ion Control, Dental Devices |
| | Number: K 062157 (Optional Format 1-2-96) |

510K Submission for CONFORM™

Page 4 of 14

Apex Dental Materials,

23329 Mallard Court

Deer Park, IL 60010