3M ESPE ADULT CROWN

K072733 · 3M Company · EBF · Feb 15, 2008 · Dental

Device Facts

• Record ID: K072733
• Device Name: 3M ESPE ADULT CROWN
• Applicant: 3M Company
• Product Code: EBF · Dental
• Decision Date: Feb 15, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3690
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

For restoration of permanent teeth best restored with a single unit full crown (e.g. as an alternative to a complex multi-surface direct restoration)

Device Story

3M ESPE Adult Crown is a preformed, tooth-colored composite crown for permanent tooth restoration. Initially malleable, the crown is trimmed and reshaped by a dentist to fit the prepared tooth; it is then light-cured to achieve high strength and cemented with permanent cement. The procedure is completed in a single office visit. The device provides a durable restoration for patients needing full crown coverage.

Clinical Evidence

Bench testing only. Evaluated physical properties including compressive strength, flexural strength, flexural modulus, depth of cure, surface hardness (Barcol), radiopacity, water sorption, water solubility, diametral tensile strength, and sensitivity to ambient light. Included an in vitro chewing simulation study comparing the subject device to Paradigm™ MZ100 Block for CEREC®.

Technological Characteristics

Preformed composite resin crown. Material properties evaluated via bench testing for strength, hardness, and solubility. Light-cured polymerization. Single-unit form factor for permanent tooth restoration.

Indications for Use

Indicated for restoration of permanent teeth requiring a single unit full crown, including as an alternative to complex multi-surface direct restorations.

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

• Sinfony™ Indirect Lab Composite
• Paradigm™ MZ100 Block for CEREC®
• 3M LVR System
• Z100™ Restorative
• 3M™ ESPE™ HAUR P-10™ Posterior Filling Material

Submission Summary (Full Text)

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K072733

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FEF | 5 |

#### 510(k) Summary 5.

3M ESPE Dental Products

3M Center St. Paul, MN 55144-1000 651 733 1110

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# 510(k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.

| 510(k) Submitter | 3M Company<br>3M ESPE Dental Products<br>3M Center, Bldg. 260-2A-11<br>St. Paul, MN 55144-1000 USA<br>Establishment Registration Number: 2110898 |
|----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact person | Scott Erickson<br>Regulatory Affairs Specialist<br>Phone: [phone]<br>Fax: [phone]<br>[e-mail] |
| Date Summary was Prepared | 9/26/07 |
| Trade Name | 3M ^TM ESPE ^TM Adult Crown |
| Common Name(s) | Preformed composite crown |
| Recommended Classification | Tooth shade resin material<br>(21 CFR 872.3690, |

Product Code: EBF)

Predicate Devices: Sinfony™ Indirect Lab Composite Paradigm™ MZ100 Block for CEREC® 3M LVR System Z100™ Restorative, 3M™ ESPE™ HAUR P-10™ Posterior Filling Material

3M ™ ESPE™ Adult Crown 510(k)

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### Description of Device:

3M TM ESPE™ Adult Crown is a tooth colored single unit crown for use as a durable restoration for permanent teeth. This preformed composite crown, manufactured by 3M ESPE, is initially malleable and can be easily customized to the crown preparation by trimming and reshaping. The crown is then light-cured to obtain its high strength and subsequently cemented in place with permanent cement. The entire crown procedure is accomplished in one visit.

### Indications for Use:

For restoration of permanent teeth best restored with a single unit full crown (e.g. as an alternative to a complex multi-surface direct restoration)

## Substantial Equivalence:

Information provided in this 510(k) submission shows that 3M ™ ESPE™ Adult Crown is substantially equivalent to the predicate devices in terms indications for use and technology, including product formulation. A biocompatibility assessment was developed for 3M ™ ESPET™ Adult Crown using standard risk assessment techniques and consideration of FDA & internationally recognized quidelines. The conclusion of the assessment is that 3M ESPE Adult Crown is safe for its intended use.

This 510(k) submission includes data from bench testing to evaluate the performance of 3M TM ESPETM Adult Crown compared to predicate devices Paradigm™ MZ100 Block for CEREO® and Sinfony™ Indirect Lab Composite. The properties evaluated include Compressive Strength. Flexural Strength, Flexural Modulus, Depth of cure, Surface Hardness (Barcol), Radiopacity, Water sorption, Water solubility, Diametral Tensile Strength and Sensitivity to Ambient Light. Also included in this submission are the results of an In Vitro Chewing Simulation study comparing 3M ™ ESPE™ Adult Crown and Paradigm™ MZ100 Block for CEREC®.

Based on bench testing conducted, the dinical performance of 3M TM ESPETM Adult Crown is expected to be substantially equivalent to crowns produced using Paradigm™ MZ100 Block for CEREC® and Sinfony TM Indirect Lab Composite.

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Public Health Service

FEB | 5 LUG

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

3M Company Mr. Scott Erickson Regulatory Affairs Specialist 3M ESPE Dental Products 3M Center, Building 275-2W-08 St. Paul. Minnesota 55144-1000

Re: K072733

Trade/Device Name: 3M™ ESPE™ Adult Crown Regulation Number: 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: II Product Code: EBF Dated: January 16, 2008 Received: January 18, 2008

Dear Mr. Erickson:

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. Erickson

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" (21CFR Part 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 vours.

Snyte f. Michino md.

Chiu Lin, Ph.D. 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 4.

Indications for Use

510(k) Number (if known): ✔ ∞ア 2733

Device Name: _ 3M™ ESPE™ Adult Crown

Indications for Use:

For restoration of permanent teeth best restored with a single unit full crown (e.g. as an alternative to a complex multi-surface direct restoration)

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| Prescription Use | X | AND/OR | Over-The-Counter Use | |
|-----------------------------|---|--------|------------------------|--|
| (Part 21 CFR 801 Subpart D) | | | (21 CFR 801 Subpart C) | |

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Kuarer

(Division Sign-Off)

Division of Anesthesiology, General Hospital

Infection Control, Dental Devices

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| 510(k) Number: | K072733 |
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3M
^TM ESPE
^TM Adult Crown 510(k)

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