(64 days)
Not Found
Not Found
No
The summary describes a physical block of material for milling and mentions no software, algorithms, or data processing that would suggest AI/ML.
No.
The device is a block of PMMA used to fabricate temporary crowns or bridges, not a device that directly treats a medical condition.
No
The device, artBloc® Temp, is used for the fabrication of dental prosthetics (multi-unit long-term temporary crowns or bridges) using CAD-controlled milling equipment. It is a material for manufacturing, not a tool for diagnosing medical conditions or diseases.
No
The device description explicitly states it is a "rectangular solid block of PMMA," which is a physical material, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for the fabrication of multi-unit long-term temporary crowns or bridges. This is a dental restoration process, not a diagnostic test performed on samples taken from the human body.
- Device Description: The description confirms it's a block of PMMA for use in milling equipment to create dental prosthetics.
- Lack of IVD Characteristics: The document 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, artBloc® Temp is a dental material used in the fabrication of temporary dental restorations, which falls outside the scope of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
artBloc® Temp is indicated for use with inLab, CEREC or other CAD-controlled milling equipment for the fabrication of multi-unit long-term temporary crowns or bridges.
Product codes (comma separated list FDA assigned to the subject device)
EBG
Device Description
A rectangular solid block of PMMA with post attachment for use in a CAD-controlled milling device for production of long-term temporary crowns and bridge abutments.
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
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 10477, ISO 3336 and ISO 10993.
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.
artegral ImCrown, VITA CAD-Temp
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
.
Premarket Notification PMMA Block for CAD-Controlled Milling Machines artBloc® Temp
Merz Dental GmbH
VIII. Premarket Notification 510(k) Summary
:
| Submitted by: | MAY - 2 2008
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: | February 15, 2008 |
| Device proprietary name: | artBloc® Temp |
| Common name: | PMMA Block |
| Classification name: | (21 CFR 872.3330) |
| Predicate devices: | artegral ImCrown
and
VITA CAD-Temp |
| Description of the device: | A rectangular solid block of PMMA with post
attachment for use in a CAD-controlled milling
device for production of long-term temporary
crowns and bridge abutments. |
| Intended use: | artBloc® Temp is indicated for use with inLab and
CEREC milling equipment for the fabrication of
multi-unit long-term temporary crowns or bridges. |
| Characteristics: | A solid rectangular block of durable and asthetic
polymer (PMMA) that can be easily milled with a
CAD-controlled device into a suitable long-term
temporary restoration (crown or bridge abutment) |
| Testing: | Tested for compliance to ISO 10477, ISO 3336 and
ISO 10993. |
Page 48 of 48
1
Image /page/1/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle-like bird with its wings spread, rendered in black. The bird is positioned to the right of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" in all capital letters. The text is arranged around the circumference of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY - 2 2008
Merz Dental GmbH C/O Mr. Richard G. Hunter Principal Washington Regulatory Consultants 5616 Mariola Place, NE Albuquerque, New Mexico 87111
Re: K080556 Trade/Device Name: artBloc® Temp Regulation Number: 21 CFR 872.3770 Regulation Name: Temporary Crown and Bridge Resin Regulatory Class: II Product Code: EBG Dated: February 25, 2008 Received: February 29, 2008
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 (OS) 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 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,
Clive 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 PMMA Block for CAD-Controlled Milling Machines
ar1Bloc® Temp Merz Dental GmbH
V. Indications for Use Statement
510(k) Number:
To be assigned
Device Name:
artBloc® Temp
Indications for Use:
artBloc® Temp is indicated for use with inLab, CEREC or other CAD-controlled milling equipment for the fabrication of multi-unit long-term temporary crowns or bridges.
k 6 40 25 €
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart )
(PLEASE DO NOT WRITE BELOW THIS LINE-
Concurrence of CDRH, Office of Device Evaluation (ODE)
Summery
Division Sign-Off) livision of Anesthesiology, General Hospital nfection Control, Dental Devices
Page 10 of 48
10(k) Number: