FLEX SPAN TEMPORARY CROWN & BRIDGE MATERIAL

K021457 · Pentron Corp. · EBG · Aug 1, 2002 · Dental

Device Facts

• Record ID: K021457
• Device Name: FLEX SPAN TEMPORARY CROWN & BRIDGE MATERIAL
• Applicant: Pentron Corp.
• Product Code: EBG · Dental
• Decision Date: Aug 1, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3770
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Flex Span Temporary Crown & Bridge Material is intended to make a temporary prosthesis, such as a crown or bridge, for use until a permanent restoration is fabricated.

Device Story

Flex Span Temporary Crown & Bridge Material is a dental restorative material used to fabricate temporary crowns and bridges. It is applied by dentists in a clinical office environment. The material features dual-cure capability, allowing for either self-curing or optional visible light curing to accelerate hardening. This flexibility allows the clinician to reduce waiting time during the procedure. The device is used to provide a temporary prosthesis while a permanent restoration is being manufactured. Safety is supported by cytotoxicity testing and the use of ingredients widely established in the dental industry.

Clinical Evidence

Bench testing only; cytotoxicity testing performed.

Technological Characteristics

Dual-cure (visible light and self-cure) resin material for temporary dental prostheses. Ingredients are standard dental industry formulations.

Indications for Use

Indicated for dental patients requiring temporary crown or bridge prostheses until permanent restoration fabrication. No specific age or gender restrictions.

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

• Temphase (K020092)

Submission Summary (Full Text)

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## AUG 01 2002

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#### 21.0 510(K) SUMMARY

Flex Span Temporary Crown & Bridge Material is intended to be used to make a temporary prosthesis, such as a crown or bridge, for use until a permanent restoration is fabricated. We believe that Flex Span Temporary Crown & Bridge Material is substantially equivalent to Sybron Dental Specialties, Inc. Temphase, K020092. Flexspan Temporary Crown and Bridge Material is to be used on dental patients in a dental office environment. Flexspan has the capability of being dual-cured, ic, visible light cure and/or self-cured. The optional light curing ability will give the dentist a choice of not waiting too long for the material to fully cure, if there is a need to fasten the hardening of the material. Cytotoxicity test has been performed. Furthermore, all the ingredients used in the formulation are widely used in dental industry and in our own composite compositions, which are known to be safe and effective.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

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#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Annmarie Tenero Pentron Corporation 53 North Plains Industrial Road P.O. Box 724 Wallingford, Connecticut 06492

## AUG 0 1 2002

Re: K021457

Trade/Device Name: Flex Span Temporary Crown & Bridge Material Regulation Number: 872.3770 Regulation Name: Temporary Crown and Bridge Resin Regulatory Class: II Product Code: EBG Dated: May 3, 2002 Received: May 6, 2002

Dear Ms. Tenero:

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 vour 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.

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.

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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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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,

Timoth A. Ulatowski 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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510(k) NUMBER (IF KNOWN): K021457

# DEVICE NAME: Flex Span Temporary Crown & Bridge Material

#### INDICATION FOR USE:

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Flex Span Temporary Crown & Bridge Material is intended to make a temporary prosthesis, such as a crown or bridge, for use until a permanent restoration is fabricated.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use (Per 21 CFR 801.109) | ✓ |
|------------------------------------------------|----|
| | OR |
| Over -The-Counter-Use (Optional Format 1-2-96) | |

| Division Sign-Off | |
|---------------------------------------------------------------------|---------|
| Division of Dental, Infection Control, and General Hospital Devices | |
| 510(k) Number | k021457 |

Jeneric/Pentron, Inc.

5.0

510K Submission - Flex Span Temporary Crown & Bridge Material