(56 days)
Not Found
No
The 510(k) summary describes a dental alloy and its mechanical properties, with no mention of AI or ML technology.
No.
The device is a gold-based alloy used as a substrate for dental restorations, which is a material used for fabrication rather than a device with a direct therapeutic effect.
No
This device is a gold-based alloy used for fabricating dental restorations, not for diagnosing medical conditions.
No
The device description clearly states it is a "high-noble, gold based alloy," which is a physical material, 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 for fabricating dental restorations using a porcelain-fused-to-metal technique. This is a structural and restorative application, not a diagnostic one.
- Device Description: The description confirms it's a dental alloy used for creating physical restorations.
- Lack of Diagnostic Elements: There is no mention of analyzing samples from the human body (like blood, urine, tissue, etc.) or providing information for the diagnosis, monitoring, or treatment of a disease or condition.
- Anatomical Site: The anatomical site is the anterior region of the mouth, where dental restorations are placed.
- Performance Studies: The performance studies focus on the mechanical and physical properties of the alloy for its suitability as a substrate, not on diagnostic accuracy or performance.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide diagnostic information. This device is a material used to create a physical structure within the body.
N/A
Intended Use / Indications for Use
AP-052-5 is a high-noble, gold based alloy suitable for use with the porcelainfused-to-metal technique of fabricating dental restorations. The mechanical and physical properties of AP-052-5 make it suitable for use as a substrate for single unit restorations in the anterior region (Bicuspids, cuspids, and incisors)
Product codes
EJT
Device Description
AP-052-5 is a high-noble, gold based alloy suitable for use with the porcelain-fusedto-metal technique of fabricating dental restorations. .
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
anterior region (Bicuspids, cuspids, and incisors)
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)
Data has been presented to demonstrate that the mechanical and physical properties of AP-052-5 make it substantially equivalent to the predicate device listed, and therefore it is suitible for use as a substrate for single unit restorations in the anterior region. Biocompatability of AP-052-5 has been assesed according to International Standard ISO 10993-1. The safety and effectiveness of AP-052-5 is therefore determined to be equivalent to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Helioform - K990670
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.3060 Noble metal alloy.
(a)
Identification. A noble metal alloy is a device composed primarily of noble metals, such as gold, palladium, platinum, or silver, that is intended for use in the fabrication of cast or porcelain-fused-to-metal crown and bridge restorations.(b)
Classification. Class II (special controls). The special control for these devices is FDA's “Class II Special Controls Guidance Document: Dental Noble Metal Alloys.” The devices are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9. See § 872.1(e) for availability of guidance information.
0
Section E
510(k) SUMMARY
| Submitted by: | Jensen Industries
50 Stillman Road
North Haven CT 06473
(203) 239-2090 phone
(203) 239-1015 fax
Contact: John Slanski |
|------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------|
| Date Prepared: | July 18, 2003 |
| Device Name:
Common Name:
Classification:
Product Code: | R&D designation AP-052-5
Dental alloy, precious metal for porcelain-fused-to-metal
Class II
EJT |
| Predicate Device(s): | Helioform - K990670 |
Device Description:
AP-052-5 is a high-noble, gold based alloy suitable for use with the porcelain-fusedto-metal technique of fabricating dental restorations. .
Data has been presented to demonstrate that the mechanical and physical properties of AP-052-5 make it substantially equivalent to the predicate device listed, and therefore it is suitible for use as a substrate for single unit restorations in the anterior region.
Biocompatability of AP-052-5 has been assesed according to International Standard ISO 10993-1.
The safety and effectiveness of AP-052-5 is therefore determined to be equivalent to the predicate device.
1
Image /page/1/Picture/1 description: The image shows a black and white logo. The logo consists of a circle with a stylized image of three birds flying inside. The birds are depicted with curved lines, suggesting movement or flight. The circle is not a solid line, but rather a series of small, connected shapes.
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850
SEP 1 7 2003
Mr. John Slanski Manager, Research & Development Jensen Industries. Incorporated 50 Stillman Road North Haven, Connecticut 06473
Re: K032267
Trade/Device Name: R&D Designation AP-052-5 Regulation Number: 872.3060 Regulation Name: Gold-Based Alloys and Precious Metal Alloys for Clinical use Regulatory Class: II Product Code: EJT Dated: July 21, 2003 Received: August 5; 2003
Dear Mr. Slanski:
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.
2
Page 2 - Mr. Slanski
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 (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 Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Susan Runne
Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use Statement
Ver/ 3 - 4/24/96 Jensen Industries Incorporated Applicant: 510(k) Number (if known): Device Name: R&D designation AP-052-5 Indications For Use: AP-052-5 is a high-noble, gold based alloy suitable for use with the porcelainfused-to-metal technique of fabricating dental restorations. The mechanical and rated to moter veemmake AP-052-5 suitable for use as a substrate for single unit restorations in the anterior region (Bicuspids, cuspids, and incisors) (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) (Per 21 CFR 801.109) (Optional Format 1-2-96) (Division Sian-Off) Division of Anesthesiology, General Hospital. Infection Control, Dental De 510(k) Number: