(192 days)
Not Found
Not Found
No
The provided text describes dental materials and their intended uses, with no mention of AI, ML, image processing, or any computational analysis of data.
No
The device descriptions for 'anaxBLEND', 'anaxGUM', and 'mock-up direct / mock-up direct flow' indicate they are dental materials used for restorations, facings, fillings, and characterizations, which are structural and aesthetic dental procedures, not therapeutic treatments for disease or injury.
No
The listed uses ("facing of fixed metal-based crowns and bridges", "anterior and posterior crowns", "inlays, onlays", "esthetic rehabilitation of gingival parts", "mock-ups", "direct anterior and posterior fillings", "indirect restorations", "core build-ups", "splinting of loose teeth", "shape and color corrections") describe materials and procedures for dental restoration and aesthetic improvement, not for diagnosing conditions or diseases.
No
The provided text describes dental materials (anaxBLEND, anaxGUM, mock-up direct/flow) used for restorations and characterization, which are physical substances, not software.
Based on the provided information, no, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended uses listed for anaxBLEND, anaxGUM, and mock-up direct/flow are all related to dental restorations and procedures performed directly on or in the patient's mouth. These are not tests performed on samples taken from the body (like blood, urine, or tissue) to diagnose a condition.
- Device Description: While the device description is "Not Found," the intended uses clearly point to materials used for filling, facing, and building up dental structures.
- Lack of IVD Characteristics: The provided information does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples.
- Providing diagnostic information about a disease or condition.
- Using reagents or assays.
The devices described are materials used in the practice of dentistry for restorative and cosmetic purposes. They are not designed to diagnose or monitor a patient's health status through in vitro testing.
N/A
Intended Use / Indications for Use
anaxBLEND:
- full or partial facing of fixed metal-based crowns and bridges;
- anterior and posterior crowns;
- inlays, onlays;
- facing of removable combined restorations (telescopic/conical crowns and attachment retained dentures);
- Characterization of dentures
anaxGUM:
- Esthetic rehabilitation of gingival parts in case of dental restorations with severe bone loss;
- Facing of the gingival area of removable combined restorations -(telescopic/conical crowns and attachment-retained dentures);
- Characterization of dentures
mock-up direct / mock-up direct flow:
- mock-ups;
- direct anterior and posterior fillings of the classes 1, 11, 111, and V -(Black);
- indirect restorations as inlays, onlays and veneers;
- extended fissure sealing of molars and premolars;
- core build-ups;
- splinting of loose teeth;
- shape and color corrections to improve the esthetic appearance
Product codes
EBF
Device Description
Not Found
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)
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
§ 872.3690 Tooth shade resin material.
(a)
Identification. Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.(b)
Classification. Class II.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
anaxDENT C/O Mr. John Balistreri Manager Director FDA- Agents 14500 Fim 470 Tarpley, Texas 78883
JAN 2 6 2012
Re: K112044
Trade/Device Name: anaxBLEND anaxGUM Mock-up direct / mock-up direct flow Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: II Product Code: EBF Dated: January 18, 2012 Received: January 23, 2012
Dear Mr. Balistreri:
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.
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.
1
Page 2 - Mr. Balistreri
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 /ucm115809.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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
es for Anthony D. Watson
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
Indications for use
K 112044 510(k) Number (if known):
anaxBLEND Device Name:
Indications For Use:
- full or partial facing of fixed metal-based crowns and bridges; -
- anterior and posterior crowns; -
- inlays, onlays; -
- facing of removable combined restorations (telescopic/conical ー crowns and attachment retained dentures);
- Characterization of dentures ー
Prescription Use No (Part 21 CFR 801 Subpart D) AND/OR
No . 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)
Supen Rume
(Division Sign-Off) (Division Sign-Off)
Division of Anesthesiology, General Hospital
Division of Anetrol, Dental Devices Division of Ancolnoontal Devices
Infection Control, Dental Devices
Page 1 of 3
510(k) Number:
3
Indications for use
510(k) Number (if known): K 112044
Device Name: anaxGUM
Indications for use:
- Esthetic rehabilitation of gingival parts in case of dental restorations with severe bone loss;
- Facing of the gingival area of removable combined restorations -(telescopic/conical crowns and attachment-retained dentures);
- Characterization of dentures -
Prescription Use No (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use No (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)
Suran Kumar
(Division Sign-Off) (Division Sign-Off)
Division of Anesthesiology, General Hospital
Division of Anesthesiology, General Devices Division of Andothoon Control, Devices
510(k) Number: K112044 Page 2 of 3
4
Indications for use
K 112044 510(k) Number (if known):
Device Name:
mock-up direct / mock-up direct flow
Indications for use:
- mock-ups; -
- direct anterior and posterior fillings of the classes 1, 11, 111, and V -(Black);
- indirect restorations as inlays, onlays and veneers; -
- extended fissure sealing of molars and premolars; -
- core build-ups; -
- splinting of loose teeth; -
- shape and color corrections to improve the esthetic appearance -
Prescription Use No (Part 21 CFR 801 Subpart D) AND/OR
No 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) | |
|---|---|
| -------------------------------------------------------- | -- |
Susan Kumar
(Division Sign-Off) (Division Sign-Off)
Division of Anesthesiology, General Hospital
Division of Anesthesiology, General Devices Division of Antoothoon Control Devices
510(k) Number: K112044
Page 3 of 3