(82 days)
DC Titan
Not Found
No
The device description and performance studies focus solely on the material properties (purity of titanium) and its use in manufacturing dental appliances, with no mention of AI or ML.
No
The device is described as titanium blanks used for manufacturing dental appliances, not for direct therapeutic treatment.
No
Explanation: The device, KaVo Everest Titanblank, is indicated for the "preparation or manufacture of permanent or removable dental appliances," and consists of titanium blanks. It does not perform any diagnostic function.
No
The device description explicitly states it consists of "pure (99.5+%) titanium blanks," which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "preparation or manufacture of permanent or removable dental appliances." This is a manufacturing process for medical devices, not a diagnostic test performed on biological samples.
- Device Description: The device is described as "pure (99.5+%) titanium blanks." This is a material used in manufacturing, not a reagent, instrument, or system intended for in vitro diagnosis.
- Lack of IVD Characteristics: The description lacks any mention of analyzing biological samples (blood, urine, tissue, etc.), detecting diseases or conditions, or providing diagnostic information.
IVDs are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The KaVo Everest Titanblank does not fit this description.
N/A
Intended Use / Indications for Use
KaVo Everest Titanblank is indicated for use in the preparation or manufacture of permanent or removable dental appliances.
Product codes (comma separated list FDA assigned to the subject device)
EJH
Device Description
KaVo Everest Titanblank consists of pure (99.5+%) titanium blanks.
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
licensed professionals
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)
None required. The claim of substantial equivalence is based on purity of the titanium (99.5+%).
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.
DC Titan
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
§ 872.3710 Base metal alloy.
(a)
Identification. A base metal alloy is a device composed primarily of base metals, such as nickel, chromium, or cobalt, that is intended for use in fabrication of cast or porcelain-fused-to-metal crown and bridge restorations.(b)
Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Dental Base Metal Alloys.” The device is 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
SECTION 9
MAR 1 % 2003
510(k) SUMMAR Y
This 510(k) summary of safety and effectiveness for KaVo Everest Titanblank is submitted in accordance with the requirements of SMDA 1990 and follows Office of Device Evaluation guidance concerning the organization and content of a 510(k) summary.
- Applicant: KaVo America 340 East Main Street Address: Lake Zurich, IL 60045 CHEMICHL, AG Manufacturer: Landstrasse 114 P.O. 732 VADUZ, LIECHTENSTEIN GERMANY FL 9490 Contact Person: Ms. Jennifer Pottala 847-550-6800 Telephone: 847-550-6825 (Fax) 800-323-8029 Preparation Date: December 2002 (of the Summary) Device Name: KaVo Everest Titanblank Common Name: Titanium metal for use in dentistry Classification: There is no classification regulation for titanium. Base metal alloy: 21 CFR 872.3710 Base metal alloy: Class II Product Code: EJH Panel: 76 Predicate devices: DC Titan Device description: KaVo Everest Titanblank consists of pure (99.5+%) titanium blanks.. KaVo Everest Titanblank is indicated for use in the preparation or Indications: manufacture of permanent or removable dental appliances.
1
KaVo proposes that the KaVo Everest Titanblank distributed in the United States be labeled:
"CAUTION: Federal (US) law restricts the use of this device to sale to or on the order of licensed professionals."
- Performance Data: None required. The claim of substantial equivalence is based on purity of the titanium (99.5+%).
- Based on the information in the notification KaVo America believes that the CONCLUSION: KaVo Everest Titanblank is substantially equivalent to the claimed predicate, DC Titan.
. . . ...
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle with its wings spread.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 2 2003
Ms. Jennifer Pottala New Product Manager KaVo America Corporation 340 East Main Street Lake Zurich, Illinois 60047
Re: K024214
Trade/Device Name: KaVo Everest Titanblank Regulation Number: 872.3710 Regulation Name: Base Metal Alloy Regulatory Class: II Product Code: EJH Dated: December 20, 2002 Received: December 20, 2002
Dear Ms. Pottala:
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 - Ms. Pottala
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. 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/dsma/dsmamain.html
Sincerely yours,
Susan Runner
Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
SECTION 7
INDICATIONS FOR USE STATEMENT
KO24214 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: KaVo Everest Titanblank________________________________________________________________________________________________________________________________________
Indications for Use Statement:
KaVo Everest Titanblank is indicated for use in the preparation or manufacture of permanent or removable dental appliances.
KaVo proposes that the materials, when intended for distribution in the United States, be labeled:
CAUTION: Federal (US) law restricts the sale of this device to, or on the order of, licensed professionals.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation
Prescription Use / (Per 21 CFR 801.109)
OR
Over-The Counter Use ________________________________________________________________________________________________________________________________________________________
Kein Mulkey for USN
General Hospital.
510(k) Number