PTM SYSTEM

K041335 · Dentsply International · EIH · Jun 16, 2004 · Dental

Device Facts

• Record ID: K041335
• Device Name: PTM SYSTEM
• Applicant: Dentsply International
• Product Code: EIH · Dental
• Decision Date: Jun 16, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 872.6660
• Device Class: Class 2

Intended Use

The PTM™ SYSTEM is used to veneer metal substructures for fixed prosthodontics.

Device Story

PTM™ System is a press-to-metal dental ceramic veneering system; used for fixed prosthodontics including anterior and posterior crowns and bridges. System components include opaque porcelain, dentin/enamel translucent ingots, enamel effect porcelains, and glaze/stain porcelain. Used by dental professionals in clinical/laboratory settings to veneer metal substructures. Provides aesthetic and functional restoration of teeth; benefits patient through durable, natural-appearing dental prosthetics.

Clinical Evidence

No clinical data provided; substantial equivalence based on formulation similarity and prior use of components in legally marketed devices.

Technological Characteristics

Dental ceramic veneering system consisting of opaque porcelain, dentin/enamel translucent ingots, enamel effect porcelains, and glaze/stain porcelain. Press-to-metal processing technique. Class II device (872.6660).

Indications for Use

Indicated for veneering metal substructures in fixed prosthodontics, including anterior and posterior crowns and bridges.

Regulatory Classification

Identification

Porcelain powder for clinical use is a device consisting of a mixture of kaolin, felspar, quartz, or other substances intended for use in the production of artificial teeth in fixed or removable dentures, of jacket crowns, facings, and veneers. The device is used in prosthetic dentistry by heating the powder mixture to a high temperature in an oven to produce a hard prosthesis with a glass-like finish.

Predicate Devices

• Finesse® Porcelain System (K940252)

Submission Summary (Full Text)

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K 041335

# 510(k) SUMMARY

NAME AND ADDRESS:

JUN 1 6 2004

DENTSPLY International World Headquarters 221 West Philadelphia Street York, PA 17405 Telefax [phone]

P. Jeffery Lehn CONTACT:

DATE PREPARED: May 18, 2004

TRADE NAME: PTM™ SYSTEM

CLASSIFICATION NAME: Porcelain Powder for Clinical Use (872.6660)

Finesse® Porcelain System PREDICATE DEVICES: K940252

DEVICE DESCRIPTION: The PTM™ SYSTEM is a press to metal system that consists of dental ceramic veneering materials designed for use in fixed prosthodontics devices that include both anterior and posterior crowns/bridges.

The PTM™ SYSTEM consists of an Opaque porcelain, Dentin/Enamel translucent ingots, Enamel Effect Porcelains, and a Glaze/Stain porcelain.

INTENDED USE: The PTM™ SYSTEM is used to veneer metal substructures for fixed prosthodontics.

TECHNOLOGICAL CHARACTERISTICS: The PTM™ SYSTEM represents a modification to the Finesse® Porcelain System. Changes have been made in the device's formulation and processing technique.

All of the components have been used in legally marketed devices. The formulations have not been changed in ways that may adversely impact safety or efficacy.

We believe that the prior use of the components in legally marketed devices, the similarity in the formulations between the modified device and the marketed device, and the data provided regarding the modifications to the marketed device support the safety and effectiveness of the PTM™ SYSTEM for the intended use.

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Image /page/1/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with three stripes representing the three branches of government. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## JUN 1 6 2004

Mr. P. Jeffery Lehn Ivi. I : vertery Donate Compliance and Regulatory Affairs Dentsply International Susquehanna Commerce Center West 221 West Philadelphia Street, Suite 60 York, Pennsylvania 17404

Re: K041335

Trade/Device Name: PTM™ System Regulation Number: 872.6660 Regulation Name: Porcelain Powder for Clinical Use Regulatory Class: II Product Code: EIH Dated: May 18, 2004 Received: May 18, 2004

Dear Mr. Lehn:

We have reviewed your Section 510(k) premarket notification of intent to market the device we have reviewed your becatermined the device is substantially equivalent (for the referenced above and nave decembined to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Increate commerce prior to that have been reclassified in accordance with the provisions of Amendinents, or to de rises that may in the (Act) that do not require approval of a premarket the r delai 1 ood, Drag, and Commay, therefore, market the device, subject to the general approval upprovision (1172) . The general controls provisions of the Act include controls provisions of thregistration, 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 If your device is classified (been additional controls. Existing major regulations affecting (1 MA), it may of subject to tax of Federal Regulations, Title 21, Parts 800 to 898. In your device our of tound in further announcements concerning your device in the Federal Register.

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#### Page 2 - Mr. Lehn

Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that 1 DX 3 issualled on that your device complies with other requirements mean that FDA has made a decommanen and regulations administered by other Federal agencies. of the Act of ally rederal statutes and reguirements, including, but not limited to: registration You must colliply with an the Pice broq. 21 CFR Part 801); good manufacturing practice and listing (21 CFR Part 067), labeling (21 CFR Part (QS) regulation (21 CFR Part 820); and if requirements as set form in the quality systems (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) This letter will anow you to begin marieting your substantial equivalence of your device to a premarket nonification. The FDF Imaling or clossification 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), If you desire specific advice to: Jour as 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 may outain of Small Manufacturers, International and Consumer Assistance at its toll-free Division of Shitas 2041 or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Olivia Liu, Ph.D.

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

(As Required by 21 CFR 807.87(e)

510(K) Number (if known): K041335

Device Name: PTM™ SYSTEM

Indications for Use:

Used to veneer metal substructures for fixed prosthodontics

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Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use | ✓ | OR | Over-The-Counter Use | |
|-----------------------------------------------|---------|----|----------------------|--------------------------|
| (Per 21 CFR 801.109) | | | | (Optional Format 1-2-96) |
| | | | | |
| Suan Quare | | | | |
| (Division Sign-Off) | | | | |
| Division of Anesthesiology, General Hospital, | | | | |
| Infection Control, Dental Devices | | | | |
| 510(k) Number: | K041335 | | | |

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