(40 days)
No
The description focuses on the material properties of the ceramic blocks and their use in a CAD/CAM system, with no mention of AI or ML in the processing or design steps.
No
The device is described as porcelain powder in block form, used to manufacture dental restorations like inlays, onlays, crowns, and veneers, which are prosthetic devices, not therapeutic.
No
The device is described as glass ceramic blocks used for manufacturing dental restorations, not for diagnosing medical conditions.
No
The device description clearly states that the device is "glass ceramic blocks" which are physical materials used to manufacture dental restorations. While software (CEREC® 3D software) is used in the process, the device itself is a physical material, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The described device, "GLASS CERAMICS," is a material (glass ceramic blocks) used to manufacture dental restorations (inlays, onlays, crowns, and veneers). It is a material that is physically shaped and placed in the patient's mouth.
- Intended Use: The intended use is the "Manufacture of all-ceramic inlays, onlays, crowns, and veneers." This is a manufacturing process for a medical device that will be implanted or placed in the body, not a diagnostic test performed on a sample.
- Device Description: The description clearly states it's a "Porcelain powder for clinical use" and "glass ceramic blocks intended to manufacture all-ceramic inlays, onlays, crowns, and vencers." This reinforces its role as a material for fabrication.
- No mention of testing on biological samples: There is no indication that this device is used to analyze or test any biological samples from a patient. The process involves scanning the clinical situation (the patient's mouth/teeth) and then fabricating a restoration.
While the process involves scanning and software, this is part of the manufacturing workflow for a physical dental restoration, not a diagnostic test.
N/A
Intended Use / Indications for Use
Manufacture of all-ceramic inlays, onlays, crowns, and veneers.
Product codes (comma separated list FDA assigned to the subject device)
EIH
Device Description
GLASS CERAMICS are classified as Porcelain powder for clinical use ( 21 C.F.R. §872.6660). They are glass ceramic blocks intended to manufacture all-ceramic inlays, onlays, crowns, and vencers. GLASS CERAMICS blocks are available in six colors (A1; A2; A3; A3.5; B3; Enamel) and five sizes (I8, 110, 112, I14, V5-12).
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): 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.
K0113949, K9204259, K980986, K022408
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.
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
:
. ਜੋ ਮੈ
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
JAN 1 8 2006
| Submitter | |
|---|---|
| Company: | 3M ESPE AG |
| Street: | ESPE Platz |
| ZIP-Code, City: | D-82229 Seefeld |
| Federal State: | Bavaria |
| Country: | Germany |
| Establishment Registration Number: | 9611385 |
| Official Correspondent: | Dr. Andreas Petermann, |
| Manager Regulatory Affairs | |
| Phone: | 011-49-8152-700 1395 |
| Fax: | 011-49-8152-700 1869 |
| E-mail: | andreas.petermann@mmm.com |
| Date: | December 7, 2005 |
traditional 510(k) GLASS CERAMICS
1
| Name of Device | |
|---|---|
| Proprietary Name: | GLASS CERAMICS |
| Classification Name | Porcelain powder for clinical use |
| Common Name: | Glass ceramic blocks |
Predicate Devices:
Lava Ccram™ / Lava Frame™ by 3M ESPE (K0113949) Paradigm™ MZ 100 block by 3M ESPE (K9204259) ProCAD® by Ivoclar Vivadent Inc. (presumably K980986) VITABLOCS® Mark II by VITA Zahnfabrik H. Rauter GmbH & Co. KG (presumably K022408)
Description for the Premarket Notification
GLASS CERAMICS are classified as Porcelain powder for clinical use ( 21 C.F.R. $872.6660). They are glass ceramic blocks intended to manufacture all-ceramic inlays, onlays, crowns, and vencers. GLASS CERAMICS blocks are available in six colors (A1; A2; A3; A3.5; B3; Enamel) and five sizes (I8, 110, 112, I14, V5-12).
Like the predicate devices, the glass ccramic blocks "ProCAD® blocks" and "VITABLOCS® Mark II" and the composite block "Paradigm™ MZ 100" blocks, GLASS CERAMICS blocks are grindable blocks for CAD/CAM systems. The allccramic restoration is produced in the dentist's office using the CEREC® system or in a dental laboratory using CEREC® Inlab; both systems are manufactured by the company Sirona, Bensheim, Germany (K012517). The clinical situation is optically scanned and then processed by the CEREC® 3D software. The restoration is fabricated in the CEREC® grinding unit.
Comparison to the predicate devices for composition, performance data and indications for use shows that GLASS CERAMICS are substantially equivalent to the predicate devices. In summary it can be concluded that safety and effectiveness requirements for GLASS CERAMICS arc fully met.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles three abstract lines or strokes, possibly representing people or services. The logo is black and white.
JAN 1 8 2006
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Public Health Service
Dr. Sabine Krischer Regulatory Affairs Specialist 3M ESPE AG ESPE Platz Seefeld, D-82229 GERMANY
Re: K053438
Trade/Device Name: Glass Ceramics Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder for Clinical Use Regulatory Class: II Product Code: EIH Dated: December 07, 2005 Received: December 09, 2005
Dear Dr. Krischer:
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 – Dr. Sabine Krischer
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" (21 CFR 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,
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
4
Indications for Use
K053438 510(k) Number (if known):
Device Name: Glass Ceramics Indications for Use:
Manufacture of all-ceramic inlays, onlays, crowns, and veneers.
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)
Susan Ruanes
A (1) 2 (1) 1) nn of Annot Pasielogy, General Hospital, . Fon Control, Dental Devices
K653438 191 : 11 : 11 : 11 : 11 : 11 : 11 : 11 : 11 : 11 : 11 : 11 : 11 : 11 : 11 : 11 : 11 : 11 : 11 : 11 : 11 : 11 : 11 : 11 : 11 : 11 : 11 : 11 : 11 : 11 : 11 : 11 : 11 : 11 : 11
Page 1 of