(64 days)
Not Found
No
The summary describes a pre-formed material for dental prosthetics and does not mention any computational or analytical capabilities that would suggest AI/ML.
No
The device is a pre-formed material used in the manufacture of temporary dental prosthetics and is not intended to provide therapy itself.
No
The document states that the KaVo Everest® C-temp is used in the "manufacture of temporary dental prosthetics" and is a "pre-formed material for use by dental laboratories in filling orders/prescriptions for dental prosthetics." There is no indication that it diagnoses any condition; instead, it is a material for creating prosthetics.
No
The device description clearly states it is a "pre-formed material," indicating a physical component, not software.
Based on the provided information, the KaVo Everest® C-temp is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The device is used in the manufacture of temporary dental prosthetics. This is a manufacturing process for a medical device, not a diagnostic test performed in vitro (outside the body) on biological samples to diagnose a condition.
- Device Description: It's described as a "pre-formed material" for use by dental laboratories. This reinforces its role as a component in creating a prosthetic, not a diagnostic tool.
- Lack of IVD Characteristics: The description doesn't mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring specific substances or markers
- Providing information for diagnosis, monitoring, or screening
The information provided clearly indicates that this device is a material used in the creation of a dental prosthetic, which falls under the category of a medical device, but not an IVD.
N/A
Intended Use / Indications for Use
The KaVo Everest® C-temp is used in the manufacture of temporary dental prosthetics to be worn 12 months or less.
Product codes (comma separated list FDA assigned to the subject device)
EBF, EBG
Device Description
The KaVo Everest® C-temp is a pre-formed material for use by dental laboratories in filling orders/prescriptions for dental prosthetics
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
dental laboratories
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)
Biocompatibility testing has been conducted to show compatibility with long term contact to human mucous membranes. The claim of substantial equivalence is based on comparisons of formulations and intended uses of the KaVo devices to legally marketed predicates and to the IDENTIFICATION of tooth shade, resins in 21 CFR 872.3690. Meets the requirements of DIN IEC 60893
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.
KaVo Everest® ZS K032081, Austenal DC-Tell (K001799)
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
§ 872.3770 Temporary crown and bridge resin.
(a)
Identification. A temporary crown and bridge resin is a device composed of a material, such as polymethylmethacrylate, intended to make a temporary prosthesis, such as a crown or bridge, for use until a permanent restoration is fabricated.(b)
Classification. Class II.
0
K06 3624
510(k) SUMMARY: KaVo Everest® C-Temp
EER 8 2007
This 510(k) summary for KaVo Everest® C-temp material 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 |
|---|---|
| Address: | 340 East Main Street |
| Lake Zurich, IL 60045 |
Manufacturer: KaVo Elektrotechnisches Werk GmbH, D-88293, Leutkirch im Allgau Germany
Contact Person: John Miller Telephone: 847-364-3931 Preparation Date of Summary: October 16, 2006 Device Name: KaVo Everest® C-temp Common Name: Dental Frame Material for Dental Prosthesis Classification: Material, tooth shade, resin 21 CFR 872.3690 Class II medical device
Product Code: EBF Panel: 76
| Predicate devices: | KaVo Everest® ZS K032081 and Austenal DC-Tell (K001799). |
|---|---|
| Device description: | The KaVo Everest® C-temp is a pre-formed material for use by |
| dental laboratories in filling orders/prescriptions for dental | |
| prosthetics | |
| Indications: | The KaVo Everest® C-temp is used in the manufacture of |
| temporary dental prosthetics to be worn 12 months or less. | |
| Performance Data: | Biocompatibility testing has been conducted to show compatibility |
| with long term contact to human mucous membranes. The claim of | |
| substantial equivalence is based on comparisons of formulations | |
| and intended uses of the KaVo devices to legally marketed | |
| predicates and to the IDENTIFICATION of tooth shade, resins in | |
| 21 CFR 872.3690. Meets the requirements of DIN IEC 60893 | |
| CONCLUSION: | Based on the information in the notification KaVo America |
| believes that The KaVo Everest® C-temp is substantially | |
| equivalent to cited legally marketed predicates and to the | |
| IDENTIFICATION in the classifying regulation (21 CFR | |
| 872.3690) |
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
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 caduceus symbol, which is a staff with two snakes coiled around it. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The text is in all capital letters and is evenly spaced around the logo.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
KaVo America C/O Mr. Daniel Kamm, P.E. Kamm & Associates P.O. Box 7007 Deerfield, Illinois 60015
8 2007 53
Re: K063624
Trade/Device Name: KaVo Everest® C-temp Regulation Number: 21 CFR 872.3770 Regulation Name: Temporary Crown and Bridge Resin Regulatory Class: II Product Code: EBG Dated: December 01, 2006 Received: December 20, 2006
Dear Mr. Kamm:
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. Daniel Kamm, P.E.
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 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 (240) 276-3150 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
3
Indications for Use
510(k) Number (if known):
Device Name: KaVo Everest® C-temp.
Indications For Use:
The KaVo Everest® C-temp is used in the manufacture of temporary dental prosthetics to be worn 12 months or less.
Prescription Use X
AND/OR
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Suna Quape
510(k) Number
(Division Sign-Off)
Division of Anesthesiology, General Hospital,
infection Control, Dental Devices
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