(8 days)
Not Found
No
The device description and performance studies focus on the material properties and biocompatibility of a dental gold alloy, with no mention of AI or ML.
No
The device is a dental gold alloy used for fabricating dental restorations, which is a material rather than a device intended to directly treat or diagnose a disease or condition.
No
The device is a dental gold alloy used for fabricating dental restorations, not for diagnosing medical conditions.
No
The device description clearly states that Apex90 is a dental gold alloy, which is a physical material used for fabrication. This is a hardware component, 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 the "Reconstruction of porcelain-to-metal dental restorations/reconstruction of dental restorations." This describes a material used in a dental procedure, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The device is a "dental gold alloy" used for fabricating dental prosthetics. This is a material used in the creation of a medical device (the dental restoration), not a diagnostic test.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing a biological sample (blood, urine, tissue, etc.)
- Detecting or measuring a substance in a biological sample
- Providing information for the diagnosis, monitoring, or treatment of a disease or condition based on the analysis of a biological sample.
The device is a material used in the manufacturing of a dental prosthetic, which is a medical device, but it is not an in vitro diagnostic device itself.
N/A
Intended Use / Indications for Use
Reconstruction of porcelain-to-metal dental restorations/reconstruction of dental restorations.
Product codes (comma separated list FDA assigned to the subject device)
EJT
Device Description
Apex90 is a dental gold alloy for the fabrication of Porcelain-Fused-to-Metal Dental Crowns, Bridges, and implant-supported prosthesis substructures, which is composed of 98% of gold and platinum bearing gold color
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
dental
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)
Apex 90 has been subjected to extensive safety, performance, and product validations prior to release. Safety tests have been performed to ensure the devices comply to applicable industry and US regulations.
An extensive review of literature pertaining to the safety and biocompatibility of dental gold alloy has been conducted: Appropriate safeguards:have been incorporated in the design of Apex 90.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
011
510(k) Submission - Apex90
This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.
Date: ________________________________________________________________________________________________________________________________________________________________________
- Company and Correspondent making the submission:
Name - We Dong Myung Industral Co.,Ltd. Telephone - 770-565-6166 Fax – 770-565-9762 Contact -- Mr. Ronald D. Arkin Internet - http://www.dmdental.co.kr
- Device :
Proprietary Name - Apex90 Common Name - Dental Alloy Classification Name - Gold-based alloys and precious metal alloys for clinical use
-
- Predicate Device :
Bio Herador SG, Jelenko Co. K003603
- Predicate Device :
-
- Classifications Names & Citations :
21CFR 872.3060, EJT, Gold-based alloys and precious metal alloys for clinical use, Class2 Guidance document for the preparation of premarket notifications [510(k)'s] for dental alloys
- Classifications Names & Citations :
-
- Description :
Apex90 is a dental gold alloy for the fabrication of Porcelain-Fused-to-Metal Dental Crowns, Bridges, and implant-supported prosthesis substructures, which is composed of 98% of gold and platinum bearing gold color
- Description :
-
- Indication for use :
Reconstruction of porcelain-to-metal dental restorations/reconstruction of dental restorations.
- Indication for use :
1
7. Contra-indications :
Potential complications associated with the use of Apex90 may include, but not limited to:
- Allergies to metals ●
8. Review :
Apex 90 has the same device characteristics as the predicate device. Material, design and use concept is similar.
Apex 90 has been subjected to extensive safety, performance, and product validations prior Safety tests have been performed to ensure the devices comply to applicable to release. industry and US regulations.
An extensive review of literature pertaining to the safety and biocompatibility of dental gold alloy has been conducted: Appropriate safeguards:have been incorporated in the design of Apex 90.
- Conclusions :
In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807, FDA's "Guidance document for the preparation of premarket notifications [510(k)'s] for dental alloys" and based on the information provided in this premarket notification We Dong Myung Dental Industrial Co.,Ltd. concludes that Apex 90 is safe and effective and substantially equivalent to predicate devices as described herein.
-
- We Dong Myung Dental Industrial Co.,Ltd. will update and include in this summary any other information deemed seasonably necessary by the FDA.
END
- We Dong Myung Dental Industrial Co.,Ltd. will update and include in this summary any other information deemed seasonably necessary by the FDA.
2
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's emblem, which consists of a stylized human figure with three overlapping profiles, representing health and well-being. The emblem is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The text is written in a simple, sans-serif font.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 2 9 2003
·We Dong Myung Dental Industrial Company limited C/O Mr. Chan Yo Won Project Engineer Underwriters Laboratories, Incorporated 2600 NW Lake Road Camas, Washington 98607-8542
Re: K030206
Trade/Device Name: APEX 90 Regulation Number: 872.3060 Regulation Name: Gold-Based Alloys and Precious Metal Alloys for Clinical Use Regulatory Class: II Product Code: EJT Dated: January 17, 2003 Received: January 21, 2003
Dear Mr. Won:
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.
3
Page 2 - Mr. Won
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 (OS) 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 vours.
Susan Runnes
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
4
K 03 020 6
010
510(k) Submission - Apex90
510(k) Number K __
Device Name: Apex90
| Indication for use: | Reconstruction of porcelain-to-metal dental restorations/reconstruction of dental restorations. |
|---|---|
| --------------------- | ------------------------------------------------------------------------------------------------- |
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON AMOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| ✓ | |
|---|---|
| Prescription Use | OR |
| (Per 21CFR801.109) |
Over-The-Counter Use
Keun Muliy -Jon MSR
(Division Sign-Off) (Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number