(49 days)
Not Found
No
The summary describes a dental ceramic system and its intended use in fabricating dental restorations. There is no mention of software, algorithms, or any technology that would suggest the use of AI or ML. The description focuses on the material composition and traditional dental fabrication processes.
No
The device is used for fabricating dental prosthetics, which are restorative rather than therapeutic in nature.
No
This device is intended for fabricating dental restorations (crowns, bridges, veneers, inlays, onlays), which is a restorative rather than a diagnostic function.
No
The device description clearly states it is a "feldspathic porcelain system" and describes its material composition, indicating it is a physical material used for fabricating dental restorations, not a software product.
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 (crowns, bridges, veneers, etc.) for dental use. This is a manufacturing process for a medical device, not a diagnostic test performed on a sample from the human body.
- Device Description: The description details the composition of a dental ceramic system, which is a material used in the fabrication process. It doesn't describe a test or assay.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples, detecting specific substances, or providing diagnostic information about a patient's health condition.
IVDs are devices used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This dental ceramic system does not fit that description.
N/A
Intended Use / Indications for Use
The product is intended to be used by dental technicians to fabricate dental restorations including porcelain fused to metal or alumina based cores crowns and bridges, laminate veneers, and inlays.
This product is intended for use in fabricating oral crowns, bridges, laminate veneers, inlays and onlays for dental use.
Product codes (comma separated list FDA assigned to the subject device)
EIH
Device Description
The GC Initial dental ceramic system is a feldspathic porcelain system based on partially crystalline but mostly vitreous materials derived from phyllosilicates such as potash or soda feldspar, several commercially available fluxes, and various refractive oxides for mechanical enhancement.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
oral
Indicated Patient Age Range
Not Found
Intended User / Care Setting
dental technicians
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): 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
§ 872.6660 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.
0
K040567
APR 2 2 2004
510(k) SUMMARY
| Submitted by: | GC America Inc |
|---|---|
| Contact Person: | Terry L. Joritz |
| Date Prepared: | February 24, 2004 |
| Proprietary Name: | GC Initial MC, GC Initial AL, GC Initial LF |
| Common Name: | Dental Ceramic Material |
| Device Classification Name: | Porcelain powder for dental use |
| Classification : | Class II medical device |
| Product Code : | EIH Regulation Number 872.6660 |
| Legally marketed equiv. devices: | Willi Geller Creation& CC Porcelain 510(k) #K981490 |
| Willi Geller Creation& AV Porcelain 510(k) #K002041 | |
| Willi Geller Creation& LF Porcelain 510(k) #K002904 | |
| Description of the Device: | The GC Initial dental ceramic system is a feldspathic porcelain |
| system based on partially crystalline but mostly vitreous mate- | |
| rials derived from phyllosilicates such as potash or soda feld- | |
| spar, several commercially available fluxes, and various refrac- | |
| tive oxides for mechanical enhancement. | |
| Intended Use of the Device: | The product is intended to be used by dental technicians to |
| fabricate dental restorations including porcelain fused to metal | |
| or alumina based cores crowns and bridges, laminate veneers, | |
| and inlays. | |
| Technological Characteristics | The GC Initial dental ceramic has identical technological cha- |
| racteristics to the Willi Geller Creation& porcelain system and | |
| indicates therefore the same harmless environmental properties | |
| as the predicate device. It also meets the appropriate ISO Stan- | |
| dards |
1
Image /page/1/Picture/1 description: The image is a black and white emblem for the U.S. Department of Health & Human Services. The emblem is circular in shape, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. The bottom half of the circle contains a stylized image of an eagle with its wings spread, with three horizontal lines above the eagle's head.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 2 2004
Ms. Terry L. Joritz Director, Regulatory Affairs and Quality Control GC America, Incorporated 3737 West 127th Street Alsip, Illinois 60803
Re: K040567
Trade/Device Name: GC Initial Dental Porcelain Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder for Clinical Use Regulatory Class: II Product Code: EIH Dated: March 02, 2004 Received: March 17, 2004
Dear Ms. Joritz:
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 (sec 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 – Ms. Terry L. Joritz
Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that 1 127 b lobalitos on that your device complies with other requirements mean that FDA nas made a deceminations administered by other Federal agencies. of the Act of ally I ederal statues and regisements, including, but not limited to: registration You must comply with an the Hec broq.21 CFR Part 801); good manufacturing practice alla listing (21 CT K Part 007), laoelity systems (QS) regulation (21 CFR Part 820); and if requirements as set form in the quality sions ontrol 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) This iction will anow you to begal finding of substantial equivalence of your device to a premarket nothreation. - The PDF Innelis 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), II you desire specific advice for your as at (301) 594-4613. Additionally, for questions on please contact the Office of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to (2011) 594-4057. Thiso, product at 807.97) you may obtain. Other general information on premainer nouried.roller. your responsibilities 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,
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
3
Indications for Use
510(k) Number (if known):
Device Name: GC Initial Dental Porcelain
Indications for Use:
This product is intended for use in fabricating oral crowns, bridges, laminate veneers, inlays and onlays for dental use.
04-0567
Prescription Use
(21 CFR Part 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR Part 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Robert Betz MD for Dr. Susan Runner
Control. Dental
510(k) Number: K040567