(89 days)
Not Found
Not Found
No
The 510(k) summary describes a ceramic material for dental restorations and its compatibility with specific milling devices. There is no mention of AI or ML in the intended use, device description, or performance studies. The submission relies on chemical composition and compliance with standards, not algorithmic performance.
No
Explanation: The device is a dental ceramic material used for preparing inlays, onlays, veneers, and crowns, which are restorative dental procedures, not therapeutic treatments.
No
The device description indicates it is a "Dental Ceramic block" used for preparing inlays, onlays, veneers, and crowns, which are restorative applications, not diagnostic ones.
No
The device description explicitly states it is a "grindable leucite reinforced glass ceramic blocks," which are physical components, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the preparation of dental restorations (inlays, onlays, veneers, crowns). This is a direct application to the patient's anatomy for restorative purposes.
- Device Description: The device is a ceramic block used with dental milling machines (CEREC and inLab). This is a material used in a manufacturing process for a medical device.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment.
IVD devices are specifically designed to perform tests on biological samples to gain diagnostic or other health-related information. This dental ceramic block does not fit that description.
N/A
Intended Use / Indications for Use
The Dental Ceramic is indicated for use with the:
- preparation of inlays .
- preparation of onlays .
- preparation of veneers .
- preparation of crowns .
The Dental Ceramic is indicated for use with CEREC devices marketed by Sirona, in Bensheim, Germany. The blooks are compatible with all CEREC devices up to the CEREC model MC XL and Inlab model MC XL.
Product codes
EIH
Device Description
The present Dental Ceramic blocks are grindable leucite reinforced glass ceramic blocks for use with CEREC® and inLab® devices marketed by Sirona, Bensheim, Germany. The blocks are are compatible with all CEREC models up to CEREC 3 and inLab but are not compatible with the CEREC model MC XL and Inlab model MC XL.
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)
This submission is an Abbreviated 510(k) as described in FDA's guidance document entitled "The New 510(k) Paradigm - Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications." Data provided in this submission to establish substantial equivalence includes chemical composition and certification of compliance with relevant consensus standards.
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 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
510(k) Summary
| Trade Name: | Dental Ceramic | MAY 21 2008 |
|---|---|---|
| Sponsor: | DMG USA, Inc. | |
| 23 Frank Mossberg Drive | ||
| Attleboro, MA 02703 | ||
| Registration # not yet assigned | ||
| Owner/Operator No. 9005969 | ||
| Device Generic Name: | Dental Ceramic | |
| Classification: | According to Section 513 of the Federal Food, Drug, and | |
| Cosmetic Act, the device classification is Class II. |
Product Description:
The present Dental Ceramic blocks are grindable leucite reinforced glass ceramic blocks for use with CEREC® and inLab® devices marketed by Sirona, Bensheim, Germany. The blocks are are compatible with all CEREC models up to CEREC 3 and inLab but are not compatible with the CEREC model MC XL and Inlab model MC XL.
Dental Ceramic is indicated for
- . preparation of inlays
- preparation of onlays .
- preparation of veneers .
- . preparation of crowns
Predicate Devices:
The Dental Ceramic material is substantially equivalent to the following currently marketed dental restorative material:
Dental Cerarnic:
| A SECTION PART MILLIAL | |
|---|---|
| DA AND AND AND AND | |
| PARTY FOR FERREAL PROPERTY | |
| . | |
| . | . |
| . " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " |
. In and a a son and a second as a more
|
Safety and Performance:
This submission is an Abbreviated 510(k) as described in FDA's guidance document entitled "The New 510(k) Paradigm - Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications." Data provided in this submission to establish substantial equivalence includes chemical composition and certification of compliance with relevant consensus standards.
Conclusion:
Based on the indications for use, technological characteristics, and comparison to the predicate devices, the Dental Ceramic has been shown to be safe and effective for its intended use.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its wing and a human figure in its body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 1 2008
DMG USA, Incorporated C/O Ms. Pamela Papineau Consultant Delphi Medical Device Consulting, Incorporated 5 Whitcomb Avenue Ayer, Massachusetts 01432
Re: K080479
Trade/Device Name: Dental Ceramic Regulation Number: Porcelain Powder for Clinical use Regulation Name: 872.6660 Regulatory Class: II Product Code: EIH Dated: April 29, 2008 Received: April 2, 2008
Dear Ms. Papineau:
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 - Ms. Papineau
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 (240) 276-0115. 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/industry/support/index.html.
Sincerely yours.
Sulfite S. Michael Davis.
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
3
DMG USA, Inc. Abbreviated 510(k) Premarket Notification 14 February 2008 Dental Ceramic
Page
510(k) Number (if known): KD 80479
Device Name: Dental Ceramic
Product Indications for Use:
The Dental Ceramic is indicated for use with the:
- preparation of inlays .
- preparation of onlays .
- preparation of veneers .
- preparation of crowns .
The Dental Ceramic is indicated for use with CEREC devices marketed by Sirona, in The Dental Ocramio is manuted i are compatible with all CEREC devices up to Bensheim, Germany. The blooks are compatible with the CEREC model MC XL and Inlab model MC XL.
OR
| Prescription Use | X |
|---|---|
| (Per 21 CFR 801 Subpart D) |
Over-the -Counter Use ________________________________________________________________________________________________________________________________________________________ (Per 21 CFR 801 Subpart C)
(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: | K082479 |