(78 days)
Temporary Crown and Bridge Resin
Not Found
No
The summary describes a preformed crown material and attachment device, with no mention of AI or ML in the intended use, device description, or performance studies.
No
The device is a provisional anterior crown used for temporary dental restoration, not for treating diseases or medical conditions. Its function is to cover and protect the tooth after preparation, not to provide therapy.
No
Explanation: The device description states its use is "as a provisional anterior crown," which is a treatment or restorative function, not a diagnostic one. It is fitted with CEREC 3D and inLab for fabrication, but its purpose is to serve as a physical replacement, not to identify medical conditions or diseases.
No
The device description explicitly states it is composed of "preformed anterior crowns composed of IPN-PMMA with an attachment device," indicating it is a physical product, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for a "provisional anterior crown" used in conjunction with dental milling systems (CEREC 3D and inLab). This is a dental prosthetic device used in the mouth for a temporary purpose.
- Device Description: The description confirms it's a "preformed anterior crown" made of dental material.
- Lack of IVD Characteristics: There is no mention of the device being used to test samples in vitro (outside the body) to diagnose, monitor, or screen for diseases or conditions. IVDs typically involve analyzing biological samples like blood, urine, or tissue.
Therefore, the artegral ImCrown is a dental device, specifically a temporary dental prosthetic, and does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
artegral ImCrown is indicated for use as a provisional anterior crown when fitted with the CEREC 3D and inLab.
Product codes
EBG
Device Description
Various shapes and sizes of preformed anterior crowns composed of IPN-PMMA with an attachment device for use in the CEREC 3D and inLab Systems.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
anterior crown
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)
Tested for compliance to ISO 3336 and ISO 10993.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Temporary Crown and Bridge Resin
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Premarket Notification Preformed Crown
artegral® ImCrown Merz Dental GmbH
VIII. Premarket Notification 510(k) Summary
| Submitted by: | Merz Dental GmbH
Eetzweg 20
D-24321 Lutjenburg
Germany
0 43 81/4 03-4 11 (phone)
0 43 81/4 09-1 07 (fax) |
|----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact person: | Dr. Med Claudia Bobrowski |
| Date prepared: | June 23, 2006 |
| Device proprietary name: | artegral® ImCrown |
| Common name: | Temporary Crown and Bridge Resin |
| Classification name: | Temporary Crown and Bridge Resin
(21 CFR 872.3770) |
| Predicate devices: | Temporary Crown and Bridge Resin |
| Description of the device: | Various shapes and sizes of preformed anterior
crowns composed of IPN-PMMA with an
attachment device for use in the CEREC 3D and
inLab Systems. |
| Intended use: | artegra® ImCrown is indicated for use as a
provisional anterior crown when fitted with the
CEREC 3D and inLab Systems |
| Characteristics: | A preformed anterior crown suitable for anterior
provisional restorations. |
| Testing: | Tested for compliance to ISO 3336 and ISO 10993. |
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/1/Picture/11 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three overlapping lines forming the staff and a snake winding around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 3 2006
Merz Dental GmbH C/O Mr. Richard G. Hunter Principal Washington Regulatory Consultants 4235 Providence Lane Tucker, Georgia 30084
Re: K061809
Trade/Device Name: Artegral ImCrown Regulation Number: 872.3770 Regulation Name: Temporary Crown and Bridge Resin Regulatory Class: II Product Code: EBG Dated: June 23, 2006 Received: June 27, 2006
Dear Mr. Hunter:
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. Hunter
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 vour 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" (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/industry/support/index.html.
Sincerely yours,
Chris Liu, Ph.D.
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Premarket Notification Preformed Crown
artegral ImCrown Merz Dental GmbH
V. Indications for Use Statement K0611809
510(k) Number:
To be assigned
Device Name:
artegral ImCrown
Indications for Use:
artegral ImCrown is indicated for use as a provisional anterior crown when fitted with the CEREC 3D and inLab.
Prescription Use X (Part 21 CFR 801 Sūbpart D)
AND/C)R
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFR 801 Subpart ) ________________________________________________________________________________________________________________________________________________________
(PLEASE DO NOT WRITE BELOW THIS LINE-
Concurrence of CDRH, Office of Device Evaluation (ODE)
Surer Rumer
v. General Hospital.
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