(53 days)
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No
The summary describes a material (acrylic polymer blocks) used for fabricating temporary dental restorations. There is no mention of software, algorithms, or any technology that would typically incorporate AI/ML.
No.
The device is used for the fabrication of temporary dental restorations, which are not considered therapeutic in and of themselves, but rather a step in a restorative process.
No
The device description indicates it is used for fabricating temporary dental restorations (bridges and crowns), which is a treatment or restorative function, not a diagnostic one.
No
The device description explicitly states it is an "acrylic polymer bloc," which is a physical material used for fabrication, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the fabrication of temporary dental restorations (bridges and crowns). This is a direct medical intervention on a patient's body, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The device is an acrylic polymer block used for milling dental prosthetics. This is a material used in the creation of a medical device, not a diagnostic tool.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
Therefore, Vita CAD-Temp is a dental material used to create temporary dental prosthetics, which falls under the category of medical devices, but not specifically In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
CAD-Temp is used for the fabrication of multi-unit, full or partial anatomical long term temporary bridge restorations with up to 2 pontics using the inLab or CEREC systems of Sirona. The bridge block can also be used for temporary crowns. The Vita CAD-Temp acrylic polymer blocs are available in the four shades 0M1T, 2M2T, 3M2T, and 4M2T and in the size CT-40 (15.5 x 19 x 39 mm).
Product codes
EBG
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three human profiles incorporated into its design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the emblem.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN - 1 2007
Ms. Elizabeth Wolfsen Regulatory Affairs Specialist VIDENT 3150 East Birch Street Brea, California 92821
Re: K070991
R070991
Trade/Device Name: Vita CAD-Temp for inLab® Regulation Number: 21 CFR 872.3770 Regulation Name: Temporary Crown and Bridge Resin Regulatory Class: II Product Code: EBG Dated: April 03, 2007 Received: April 09, 2007
Dear Ms. Wolfsen:
We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section 310(K) prematics is substant (for the indications for the indications for referenced above and have determined the devices marketed in interstate commence
use stated in the enclosure) to legally market devices marketed in interstate on to devices t use stated in the enclosure) to legally hiar Recon present Food Device Amendments, or to devices that pror to May 28, 1976, ure enactinent cate of the Federal Food. Drug, and Cosmetic
have been reclassified in accordance with the provisions of the Features (RMA). You may have been reciassified in accordance with the provisions of the Act. The next Act (Act) that do not require approval of a prematiconspisions of the Act. The general therefore, market the device, subject to the general on your cegastration, listing of devices, good
controls provisions of the Act include requirements for annualize and adu controls provisions of the Net metade requiritions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), in If your device is classified (See above) into elections affecting your device can be
may be subject to such additional controls and 1904 - In oddition, FDA may publish may be subject to such additional controls. "Internet and to 898. In addition, FDA may publish found in the Code on the concerning your device in the Federal Register.
1
Page 2 - Ms. Elizabeth Wolfsen
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.
Sugitte Y. Michine Ond
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
2
Indications for Use
510(k) Number (if known): K070991
Vita CAD-Temp for inLab® Device Name:
Indications For Use:
CAD-Temp is used for the fabrication of multi-unit, full or partial anatomical long term temporary bridge restorations with up to 2 pontics using the inLab or CEREC systems of Sirona. The bridge block can also be used for temporary crowns. The Vita CAD-Temp acrylic polymer blocs are available in the four shades 0M1T, 2M2T, 3M2T, and 4M2T and in the size CT-40 (15.5 x 19 x 39 mm).
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (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)
Hai Ruby for KSR
(ion Sign-Off)
ion of Anesthesiology, General Hospital, Section 4 Page 1 of 1
ion Control, Dental Devices
(k) Number: K070991