(196 days)
Not Found
No
The description focuses on the material composition and manufacturing process (CAD/CAM, machining, sintering) of a dental restoration block, with no mention of AI or ML for analysis, design, or any other function.
No.
The device is a material (zirconia powder) used in CAD/CAM technology to create dental restorations like copings, bridges, and frameworks. It is an intermediate product in the manufacturing process of these restorations, which themselves replace or repair damaged teeth. The powder itself does not directly treat or diagnose a disease or condition, nor does it restore normal function by itself. Its purpose is to be formed into a device that will perform a therapeutic function.
No
This device is a material used to produce dental prosthetics (copings, bridges, framework core material), not a device used to diagnose a medical condition.
No
The device description clearly states it is a "partially sintered yttria (yttrium oxide) stabilized zirconia (zirconium oxide) powder" which is a physical material, not software. The description focuses on the material properties and manufacturing process of a physical dental restoration component.
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 DLMS-Zirblocks are materials used in a CAD/CAM process to create dental prosthetics (copings, bridges, framework core material). They are a physical material that is machined and then placed in the patient's mouth.
- Lack of Biological Sample Testing: The description does not mention any testing of biological samples from a patient. The process involves preparing a tooth, taking an impression, scanning the impression, machining the material, and then placing the finished product in the mouth.
Therefore, the function and intended use of this device clearly fall outside the scope of in vitro diagnostics.
N/A
Intended Use / Indications for Use
Intended for use in CAD/CAM technology to produce copings, bridges, and framework core material usage for fixed prosthodontics. Then veneered with porcelain glass to create final restoration.
Product codes (comma separated list FDA assigned to the subject device)
EIH
Device Description
DLMS-Zirblocks is a partially sintered yttria (yttrium oxide) stabilized zirconia (zirconium oxide) powder that is capable of machining by modern methods. The material is designated as TZP (slightly stronger) or TZPA (slightly more translucent). The dentist prepares the tooth surfaces, sends a properly prepared impression of those surfaces to the dental laboratory where it is scanned and an inlay or onlay prepared by modern computerized lathe methods, sintered to full density, and returned to the dentist. The dentist then finally prepares the tooth surfaces involved and cements (lutes) the inlay or only in place with standard dental adhesives (luting) materials. The material is radio-opaque, for ready visualization.
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
Dentist, dental laboratory
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
Rosal37
DLMS 14201 N. 87ª Street, Suite A-105 Scottsdale, AZ 85260
.
:
:
.
・・
Section G
FEB 1 0 2009
and the comments of the count
.
510(k) Summary
| 510(k) Summary | This summary of 510(k) safety and effectiveness is being submitted in accordance with the requirements of 21 CFR 807.92 |
|---|---|
| Applicant | Dental Laboratory Milling Supplies (DLMS) |
| 14201 N. 87th Street, Suite A-105 | |
| Scottsdale, AZ 85260 | |
| Contact Person | Name and Title: Scott Atkin, Founder DLMS |
| Ph: 480-948-0466 | |
| Fax: 480-443-7666 | |
| Date Prepared | 25 JUL 2008 |
| Trade Name | DLMS-Zirblocks |
| Classification Name | Porcelain Powder for Clinical Use |
| Common Name | CAM-Blanks |
| Predicate Devices | Legally marketed device to which we claim equivalence: Metoxit CAM-Blanks, Metoxit AG, K072569 |
| Description | DLMS-Zirblocks is a partially sintered yttria (yttrium oxide) stabilized zirconia (zirconium oxide) powder that is capable of machining by modern methods. The material is designated as TZP (slightly stronger) or TZPA (slightly more translucent). The dentist prepares the tooth surfaces, sends a properly prepared impression of those surfaces to the dental laboratory where it is scanned and an inlay or onlay prepared by modern computerized lathe methods, sintered to full density, and returned to the dentist. The dentist then finally prepares the tooth surfaces involved and cements (lutes) the inlay or only in place with standard dental adhesives (luting) materials. The material is radio-opaque, for ready visualization. |
| Indications for Use | Intended for use in CAD/CAM technology to produce copings, bridges, and framework core material usage for fixed prosthodontics. Then veneered with porcelain glass to create final restoration. |
| Technological | |
| Characteristics | The technological characteristics between the predicate devices and the proposed device are identical. There is no difference in fundamental technology. They have the same intended use and are made from the same materials. |
| Substantial | |
| Equivalence | The product is the exact same material used for the predicate device, the Metoxit CAM-Blanks, and is equivalent in function and intended use to the predicate device. |
| Conclusion | There are no significant differences between the DLMS-Zirblocks and the predicate device, the Metoxit CAM-Blanks, and therefore, the DLMS-Zirblocks are equally safe and effective |
:
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Dental Laboratory Milling Supplies Mr. Scott Atkin 14201 North 87th Street Suite A-105 Scottsdale, Arizona 85260
FEB 1 0 2009
Re: K082137
Trade/Device Name: DLMS-Zirblocks Regulation Number: 872.6660 Regulation Name: Porcelain Powder For Clinical Use Regulatory Class: II Product Code: EIH Dated: February 4, 2009 Received: February 5, 2009
Dear Mr. Atkin:
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 - Mr. Atkin
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Sutie Y. Michael Davis.
Ginette Y. Michaud, M.D. Acting Director : Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known): _KORA)3
Device Name: DLMS-Zirblocks
Indications for Use:
Intended for use in CAD/CAM technology to produce copings, bridges, and framework core material usage for fixed prosthodontics. Then veneered with porcelain glass to create final restoration.
Prescription Use X (Part 21 CFR 801 Subpart D)
Over-The-Counter Use AND/OR (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
Suna Reaser
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K082137