(106 days)
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Not Found
No
The device description and intended use clearly describe impression materials used for creating physical models of teeth and gums. There is no mention of any software, data processing, or analytical capabilities that would suggest the use of AI or ML.
No
The device is an impression material used to create models of teeth and gums for the production of restorative prosthetics. It does not directly treat or prevent a disease or condition.
No
The intended use of the Bonasil A* Impression Materials is to reproduce the structure of a patient's teeth and gums to provide models for study and for the production of restorative prosthetics. It does not state that the device is used to diagnose a medical condition or disease.
No
The device description and intended use clearly describe impression materials used to reproduce physical structures (teeth and gums), indicating a physical product, not software.
Based on the provided information, the Bonasil A* Impression Materials are not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Bonasil A Intended Use:* The intended use of Bonasil A* is to create physical impressions of a patient's teeth and gums. These impressions are then used to create models for study and the production of dental prosthetics. This process involves physically reproducing anatomical structures, not analyzing biological specimens for diagnostic purposes.
The device is used directly on the patient's anatomy to create a mold, which is a different function than analyzing a biological sample.
N/A
Intended Use / Indications for Use
The Bonasil A* Impression Materials are intended to:
- be placed on an impression tray (or injected directly into the mouth, depending on the technique and device) and used to reproduce the structure of a patient's teeth and gums;
- provide models for study and for production of restorative prosthetics devices;
Indications for use:
- BONASIL A* Putty (putty normal set, putty fast set, putty extra hard, lab putty) is to be used as a preliminary material for:
- Two step putty/wash technique
- Single step putty/wash technique
- Functional peripheries
- Crown/bridge work
- Inlays, onlays
- BONASIL A* Heavy (heavy normal set, heavy fast set) is to be used as a heavy body material for:
- Two step putty/wash technique
- Single step putty/wash technique
- Functional peripheries
- Crown/bridge work
- Inlays, onlays
- BONASIL A* Monophase (monophase normal set, monophase fast set) is to be used as a semi-heavy body material for:
- Single step putty/wash technique
- Functional peripheries
- Crown/bridge work
- Inlays, onlays
- BONASIL A* Regular (regular normal set, regular fast set) is to be used as a medium body material for:
- Two step putty/wash technique
- Single step putty/wash technique
- Functional peripheries
- Reline impressions
- Crown/bridge work
- Inlays, onlays
- BONASIL A* Light (light normal set, light fast set) is to be used as a light body material for:
- Two step putty/wash technique
- Single step putty/wash technique
- Functional peripheries
- Reline impressions
- Crown/bridge work
- Inlays, onlays
- BONASIL A* Bonabite (bonabite fast set) is to be used as a light body material for: .
- Making accurate occlusal registrations
- Standards bite registrations in the end bite position
- Key material for needle point registration
- Production of small model segments
- An optical registration of occlusal data for CAD/CAM/CIM systems
- BONASIL A* Alginate free (normal set, fast set) is an alternative to traditional alginate materials and is suitable for:
- Preliminary impressions
- Anatomic models
- Fabricating temporary crowns and bridges
- Opposing dentition
- Fabricating simple removable prosthetic restorations
- Orthodontic work
- Case study models
Product codes
ELW
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
patient's teeth and gums
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Not Found
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.
Not Found
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
§ 872.3660 Impression material.
(a)
Identification. Impression material is a device composed of materials such as alginate or polysulfide intended to be placed on a preformed impression tray and used to reproduce the structure of a patient's teeth and gums. The device is intended to provide models for study and for production of restorative prosthetic devices, such as gold inlays and dentures.(b)
Classification. Class II (Special Controls).
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 symbol with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the symbol. The text is in all capital letters and is evenly spaced around the circle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -W066-G609 Silver Spring, MD 20993-0002
Mr. Dimitris Prantsidis DMP, Limited 2nd Km Kalyvion Avenue, Markopoulo Industrial Zone Markopoulo GREECE 19003
JAN 1 3 2011
Re: K102836
Trade/Device Name: BONASIL A* Impression Materials, to include:
- BONASIL A* Putty: Putty normal set, Putty fast set, Putty soft, Putty extra hard, Lab Putty
- BONASIL A* Heavy: Heavy normal set, Heavy fast set
- · BONASIL A · Monophase: Monophase normal set, Monophase fast set
- · BONASIL A* Regular: Regular normal set, Regular fast set
- · BONASIL A* Light: Light normal set, Light fast set
- · BONASIL A* Bonabite: Bonabite fast set
· BONASIL A * Alginate Free: Alginate free normal set, Alginate free fast set Regulation Number: 21 CFR 872.3660 Regulation Name: Impression Material Regulatory Class: II
Product Code: ELW
Dated: December 22, 2010
Received: December 22, 2010
Dear Mr. Prantsidis:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
1
Page 2 - Mr. Prantsidis
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm 1.15809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely vours.
for
Anthony D. Watson, P
Anthony D. Watson, B.S., M.S., M.B.A. Director
· Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
K/02836
SECTION: Indications for Use Statement 4.
Device name: BONASIL A* Impression Materials, to include:
- BONASIL A* Putty .
- Putty normal set -
- Puttv fast set
- Putty soft -
- Putty extra hard -
- Lab puttv
- BONASIL A* Heavy .
- Heavy normal set
- Heavy fast set
- BONASIL A* Monophase .
- Monophase normal set
- Monophase fast set
- BONASIL A* Regular .
- Regular normal set ।
- Regular fast set
- BONASIL A* Light ●
- Light normal set
- Light fast set
- BONASIL A* Bonabite ●
- Bonabite fast set ।
- BONASIL A* Alginate Free
- Alginate free normal set
- Alginate free fast set l
Intended use:
The Bonasil A* Impression Materials are intended to:
- be placed on an impression tray (or injected directly into the mouth, depending on the technique and device) and used to reproduce the structure of a patient's teeth and gums;
- provide models for study and for production of restorative prosthetics devices;
Indications for use:
- · BONASIL A* Putty (putty normal set, putty fast set, putty extra hard, lab putty) is to be used as a preliminary material for:
- ~ Two step putty/wash technique
- Single step putty/wash technique
- Functional peripheries
- Crown/bridge work
- Inlays, onlays
3
- · BONASIL A* Heavy (heavy normal set, heavy fast set) is to be used as a heavy body material for:
- Two step putty/wash technique
- Single step putty/wash technique
- Functional peripheries
- Crown/bridge work
- Inlays, onlays
- · BONASIL A* Monophase (monophase normal set, monophase fast set) is to be used as a semi-heavy body material for:
- Single step putty/wash technique
- Functional peripheries
- Crown/bridge work
- Inlays, onlays
- · BONASIL A* Regular (regular normal set, regular fast set) is to be used as a medium body material for:
- Two step putty/wash technique
- Single step putty/wash technique
- Functional peripheries
- Reline impressions
- Crown/bridge work
- Inlays, onlays
- . BONASIL A* Light (light normal set, light fast set) is to be used as a light body material for:
- Two step putty/wash technique
- Single step putty/wash technique
- Functional peripheries
- Reline impressions
- Crown/bridge work
- Inlays, onlays
- BONASIL A* Bonabite (bonabite fast set) is to be used as a light body material for: .
- Making accurate occlusal registrations
- Standards bite registrations in the end bite position
- Key material for needle point registration
- Production of small model segments
- An optical registration of occlusal data for CAD/CAM/CIM systems
4
-
· BONASIL A* Alginate free (normal set, fast set) is an alternative to traditional alginate materials and is suitable for:
-
Preliminary impressions
-
Anatomic models
-
Fabricating temporary crowns and bridges
-
Opposing dentition
-
Fabricating simple removable prosthetic restorations
-
Orthodontic work
-
Case study models
-
(Division Sign-Off) Division of Anesthesio Infection Control as 510(k) Nambaz