(286 days)
Not Found
No
The provided text describes a dental abutment system and does not mention any AI or ML components or functionalities.
No
The device is a material/solution for fabricating dental restorations (abutments and crowns) for support of restorations, not a therapeutic device for treating a disease or condition.
No
The device is described as "intended for use in partially or fully endentuous mandibles and maxillae in support of single or multiple-unit cement retained restorations" and for "fabrication of hybrid abutments and hybrid abutment crowns." This indicates it is a restorative device used for treatment, not for diagnosing a condition.
No
The 510(k) summary describes a physical dental abutment solution (IPS e.max Press Abutment Solutions) used for restorations, not a software-only device. The predicate and reference devices are also physical dental components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device as being used in the mouth (mandibles and maxillae) to support dental restorations. This is a direct interaction with the patient's body for a therapeutic or restorative purpose.
- Lack of IVD Characteristics: An IVD is a medical device used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The provided description does not mention any such use or interaction with bodily specimens.
- Anatomical Site: The anatomical site is the mandibles and maxillae, which are parts of the patient's body, not a specimen.
Therefore, based on the provided text, IPS e.max® Press Abutment Solutions is a dental device used for restorative purposes within the patient's mouth, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
IPS e.max® Press Abutment Solutions is intended for use in partially or fully endentuous mandibles and maxillae in support of single or multiple-unit cement retained restorations.
IPS e.max Press Abutment Solutions is recommended for the fabrication of:
- Hybrid abutments for single-tooth restorations
- Hybrid abutment crowns for restorations
Product codes
NHA, EIH
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
Not Found
Anatomical Site
endentulous mandibles and maxillae
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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.3630 Endosseous dental implant abutment.
(a)
Identification. An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)
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 with three tail feathers, representing the department's mission to protect the health of all Americans and provide essential human services. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA".
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
OCT 1 8 2012
Ivoclar Vivadent AG C/O Ms. Donna Marie Hartnett Director of Quality Assurance / Regulatory Affairs Ivoclar Vivadent, Incorporated 175 Pineview Drive Amherst, New York 14228
Re: K120053
Trade/Device Name: IPS e.max® Press - Abutment Solutions Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA, EIH Dated: September 28, 2012 Received: October 2, 2012
Dear Ms. Hartnett:
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- Ms. Hartnett
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/Resourcesfor You/Industry/default.htm.
Sincerely vours.
hi for
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 170053 510(k) Number (if known):
Device Name: IPS e.max® Press - Abutment Solutions
Indications For Use:
IPS e.max® Press Abutment Solutions is intended for use in partially or fully endentuous mandibles and maxillae in support of single or multiple-unit cement retained . restorations.
IPS e.max Press Abutment Solutions is recommended for the fabrication of:
- Hybrid abutments for single-tooth restorations •
- Hybrid abutment crowns for restorations -
The following Ti bases are intended to be used with IPS e.max Press Abutment Solutions.
| Implant manufacture | Implant system, diameter | Compatible Ti base
(abutment), dimensions
diameter = D
gingiva height = GH
height = HTi |
|---------------------|-------------------------------------------------------|-----------------------------------------------------------------------------------------------------|
| Straumann® | Bone Level RC
Ø 4.1 mm or Ø 4.8 mm
510K K062129 | RC Cementable abutment
D 5.0-6.5 mm
GH 1.0-3.0 mm
HTi 4.0-5.5 mm
510K K072071 |
Prescription Use X AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) Page 1 of 1
| (Division Sign-Off) | |
|---|---|
| Division of Anesthesiology, General Hospital Infection Control, Dental Devices |
| 510(k) Number: | K120053 |
|---|---|
| ---------------- | --------- |