KAVO EVEREST C-TEMP

K063624 · Kavo America · EBG · Feb 8, 2007 · Dental

Device Facts

• Record ID: K063624
• Device Name: KAVO EVEREST C-TEMP
• Applicant: Kavo America
• Product Code: EBG · Dental
• Decision Date: Feb 8, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3770
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The KaVo Everest® C-temp is used in the manufacture of temporary dental prosthetics to be worn 12 months or less.

Device Story

KaVo Everest® C-temp is a pre-formed dental material used by dental laboratories to fabricate temporary dental prosthetics. The material is processed into final prosthetic shapes for patient use. It is intended for temporary applications with a wear duration of 12 months or less. The device is utilized in a laboratory setting by dental technicians to fulfill prescriptions provided by clinicians. The final prosthetic benefits the patient by providing a temporary restoration during the treatment process. Biocompatibility testing confirms suitability for long-term contact with human mucous membranes.

Clinical Evidence

Bench testing only. Biocompatibility testing was conducted to demonstrate safety for long-term contact with human mucous membranes.

Technological Characteristics

Pre-formed dental frame material for temporary prosthetics. Meets DIN IEC 60893 standards. Material is a tooth-shade resin.

Indications for Use

Indicated for patients requiring temporary dental prosthetics to be worn for a duration of 12 months or less.

Regulatory Classification

Identification

A temporary crown and bridge resin is a device composed of a material, such as polymethylmethacrylate, intended to make a temporary prosthesis, such as a crown or bridge, for use until a permanent restoration is fabricated.

Predicate Devices

• KaVo Everest® ZS (K032081)
• Austenal DC-Tell (K001799)

Submission Summary (Full Text)

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K06 3624

## 510(k) SUMMARY: KaVo Everest® C-Temp

EER 8 2007

This 510(k) summary for KaVo Everest® C-temp material is submitted in accordance with the requirements of SMDA 1990 and follows Office of Device Evaluation guidance concerning the organization and content of a 510(k) summary.

| Applicant: | KaVo America |
|------------|-----------------------|
| Address: | 340 East Main Street |
| | Lake Zurich, IL 60045 |

Manufacturer: KaVo Elektrotechnisches Werk GmbH, D-88293, Leutkirch im Allgau Germany

Contact Person: John Miller Telephone: [phone] Preparation Date of Summary: October 16, 2006 Device Name: KaVo Everest® C-temp Common Name: Dental Frame Material for Dental Prosthesis Classification: Material, tooth shade, resin 21 CFR 872.3690 Class II medical device

Product Code: EBF Panel: 76

| Predicate devices: | KaVo Everest® ZS K032081 and Austenal DC-Tell (K001799). |
|---------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device description: | The KaVo Everest® C-temp is a pre-formed material for use by<br>dental laboratories in filling orders/prescriptions for dental<br>prosthetics |
| Indications: | The KaVo Everest® C-temp is used in the manufacture of<br>temporary dental prosthetics to be worn 12 months or less. |
| Performance Data: | Biocompatibility testing has been conducted to show compatibility<br>with long term contact to human mucous membranes. The claim of<br>substantial equivalence is based on comparisons of formulations<br>and intended uses of the KaVo devices to legally marketed<br>predicates and to the IDENTIFICATION of tooth shade, resins in<br>21 CFR 872.3690. Meets the requirements of DIN IEC 60893 |
| CONCLUSION: | Based on the information in the notification KaVo America<br>believes that The KaVo Everest® C-temp is substantially<br>equivalent to cited legally marketed predicates and to the<br>IDENTIFICATION in the classifying regulation (21 CFR<br>872.3690) |

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

KaVo America C/O Mr. Daniel Kamm, P.E. Kamm & Associates P.O. Box 7007 Deerfield, Illinois 60015

8 2007 53

Re: K063624

Trade/Device Name: KaVo Everest® C-temp Regulation Number: 21 CFR 872.3770 Regulation Name: Temporary Crown and Bridge Resin Regulatory Class: II Product Code: EBG Dated: December 01, 2006 Received: December 20, 2006

Dear Mr. Kamm:

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. Daniel Kamm, P.E.

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,

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):

Device Name: KaVo Everest® C-temp.

Indications For Use:

The KaVo Everest® C-temp is used in the manufacture of temporary dental prosthetics to be worn 12 months or less.

Prescription Use X

AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Suna Quape

510(k) Number

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

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