(29 days)
No
The summary describes a system of dental ceramic materials for veneering metal substructures, with no mention of software, algorithms, or any technology related to AI or ML.
No
The device is a dental ceramic veneering material used to veneer metal substructures for fixed prosthodontics, not for therapeutic purposes.
No
Explanation: The device is a dental ceramic veneering material used for fixed prosthodontics, not for diagnosing medical conditions.
No
The device description explicitly states it consists of "dental ceramic veneering materials" and "porcelain," which are physical materials, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "Used to veneer metal substructures for fixed prosthodontics." This describes a material used in the fabrication of dental restorations, not a test performed on a biological sample to diagnose a condition.
- Device Description: The description details dental ceramic veneering materials (porcelain, ingots, etc.) used to build up dental prosthetics. This aligns with a dental material, not an IVD.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Testing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring analytes
- Providing diagnostic information about a patient's health status
The device is clearly a dental material used in the fabrication of dental prosthetics.
N/A
Intended Use / Indications for Use
Used to veneer metal substructures for fixed prosthodontics
Product codes
EIH
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.6660 Porcelain powder for clinical use.
(a)
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.(b)
Classification. Class II.
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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 (717) 849-4343
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 (301) 594-4613. 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 (301) 443-6597 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
(PLEASE DO NOT WRITE BELOW THIS LINE—CONTINUE ON ANOTHER PAGE IF NEEDED)
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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