(62 days)
Not Found
Not Found
No
The provided 510(k) summary contains no mention of AI, ML, image processing, or any other terms typically associated with AI/ML technology in medical devices. The description is minimal and focuses solely on the intended use for dental restorations.
No
The intended use describes the reconstruction of dental restorations, which is a restorative rather than a therapeutic (treating disease or illness) function.
No
The intended use is "Reconstruction of porcelain to metal dental restorations/reconstruction of dental restorations," which describes a treatment or restorative function, not a diagnostic one.
Unknown
The provided 510(k) summary is incomplete and lacks crucial information about the device description. Without knowing the nature of the device and how it achieves its intended use, it's impossible to determine if it's software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "Reconstruction of porcelain to metal dental restorations/reconstruction of dental restorations." This describes a process performed on dental materials outside of the human body, specifically for the purpose of repairing or rebuilding dental prosthetics.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples from the human body (blood, urine, tissue, etc.).
- Providing information about a patient's health status, disease, or condition.
- Being used for diagnosis, monitoring, or screening.
IVDs are devices used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The described device clearly falls outside of this definition.
N/A
Intended Use / Indications for Use
Reconstruction of porcelain to metal dental restorations/reconstruction of dental restorations.
Product codes
EJT, EJS
Device Description
Not Found
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)
Not Found
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
Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a circular design with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling three stylized waves or stripes, which is a common element in the HHS seal.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR = 1 2004
Heraeus Kulzer GmbH & Company KG C/O Ms. Cheryl V. Zimmerman Manager, Quality Operations and Compliance Heraeus Kulzer, Incorporated 4315 South Lafayette Boulevard South Bend, Indiana 46614
Re: K034049
KU34049
Trade/Device Names: Herador EC, Herador PF, Herador H, Herador NH, Herador G, Heralor d N Herador GG, Herador MP, Heraloy U, Heraloy G, Herabond N, Albabond C, Albabond B, Albabond A, Bio Heranorm, Mainbond KF, Albabold C, Firsterer KF, Alba KF, Maingold SG, Maingold MP, Kelainingold FRF, Horagold TK, Maingold G, Maingold GV, Bio Maingold IT, Bio Maingold I, Hera SG, Hera PF, and Alba SG Regulation Number: 21 CFR 872.3060 Regulation Name: Gold Based Alloys and Precious Metal Alloys for Clinical Use Regulatory Class: II Product Code: EJT and EJS Dated: December 18, 2003
Received: January 08, 2004
Dear Ms. Zimmerman:
We have reviewed your Section 510(k) premarket notification of intent to market the device We have revewed your section 510(x) premained is substantially equivalent (for the indications for referenced above and have decemined the ac-rices marketed in interstate comments on to devices that use stated in the enclosure) to regally manufacture . Amedical Device American . Or to devices that prior to May 26, 1970, the enactions and of the Federal Food, Drug, and Cosmetic
have been reclassified in accordance with the provisions of the stime (DMA). You may have been reclassified in accordance with the provision (PMA). You may.
Act (Act) that do not require approval of a premarket approval application Act. The separa Act (Act) that do not require approval or a provisions of the Act . The ect. The general therefore, market the device, subject to the general voir annual registration, listing of devices, good
controls provisions of the Act include requirements for and adultarsti controls provisions of the nerade requibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (Sec above) into Existing major regulations affecting your device can be may be subject to such additions, Title 21, Parts 800 to 898 In addition, FDA may publish found in the Oode of I concerning your device in the Federal Register.
1
Page 2 – Ms. Cheryl V. Zimmerman
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. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 may be obtained 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.
Clus
Chiu S. Lin. PhD 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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Page 1 of 1
11 - 11 -
1634049 510(k) Number (if Known):
Device Name:
Herador EC Mainbond KF Keramikgold PKF Herador PF Hera KF Herador C Alba KF Herador H Herador NH Maingold SG Maingold MP Herador G Maingold OG Herador GG Bio Maingold TK Herador MP Maingold G Heraloy U Heraloy G Maingold GV Bio Maingold IT Herabond N Bio Maingold I Albabond C Hera SG Albabond B Hera PF Albabond A Alba SG Bio Heranorm
Indications For Use:
Reconstruction of porcelain to metal dental restorations/reconstruction of dental restorations.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device evaluation (ODE) | |
|---|---|
| (Division Sign-Off) | |
| Division of Anesthesiology, General Hospital, | |
| Infection Control, Dental Devices | |
| 510(k) Number: | X034049 |
| Prescription Use | |
| (Per 21 CFR 801.109) | X |
| OR | Over-The-Counter Use |
(Optional Format 1-2-96)