(89 days)
No
The summary describes a physical dental abutment and its use with a CAD/CAM system for fabrication. There is no mention of AI or ML in the intended use, device description, or performance studies.
No.
This device describes an implant-prosthetic titanium abutment used as a bonding base for hybrid abutments, which is a component in dental restoration rather than a device intended to treat or cure a disease or condition.
No
Explanation: The device is described as an implant-prosthetic titanium abutment serving as a bonding base for hybrid abutments. Its function is to support a dental prosthesis, not to diagnose a condition or disease.
No
The device description clearly states it is a "titanium abutment" and a "bonding base for hybrid abutments," which are physical components, not software. The performance studies also involve physical testing (compression-bending).
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 an "Implant-prosthetic titanium abutment" used as a "bonding base for hybrid abutments" in dental procedures. This is a device used in vivo (within the body) for structural support and restoration, not for testing samples in vitro (outside the body) to diagnose a condition.
- Device Description: The description details a physical component (an abutment) designed to be used with a CAD/CAM system to fabricate a dental prosthesis. This aligns with a medical device used for treatment or restoration, not for diagnostic testing.
- Lack of IVD Characteristics: There is no mention of the device being used to analyze biological samples (blood, urine, tissue, etc.), detect specific analytes, or provide diagnostic information about a patient's health status.
Therefore, the CONELOG® Titanium base CAD/CAM is a dental implant component, which falls under the category of a medical device, but not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
CONELOG® Titanium base CAD/CAM - Implant-prosthetic titanium abutment for CONELOG® implants with connection, as a bonding base for hybrid abutments. - The Titanium base CAD/CAM for implant Ø 3.3 mm is designed only for hybrid abutments in the area of the upper lateral incisors and lower central and lateral incisors.
Product codes
NHA
Device Description
CONELOG Titanium base CAD/CAM is an abutment designed to be used with the Sirona CAD/CAM System in Coris ZI meso L and meso S to fabricate a hybrid abutment with an angle up to 20°.The Titanium base CAD/CAM is available in four implant platform sizes (3.3 mm 3.8 mm, 4.3 mm, and 5.0 mm), two gingival heights (0.8 mm or 2.0 mm) and is supplied with the corresponding screw. All design parameters are according to the cleared Sirona CAD/CAM System parameters.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
upper lateral incisors and lower central and lateral incisors (dental)
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)
Non-clinical testing data submitted, referenced, or relied upon to demonstrate substantial equivalence included: static and dynamic compression-bending testing according to ISO 14801 Dentistry - Implants - Dynamic fatigue test for endosseous dental implants. Clinical data were not submitted in this premarket notification.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K133991, K113779, K083496, K111421
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.)
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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 caduceus symbol, which is a staff with two snakes entwined around it. The symbol is surrounded by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 17, 2015
Altatec GmbH c/o Ms. Linda K. Schulz Regulatory Affairs PaxMed International, LLC 12264 El Camino Real, Suite 400 San Diego, CA 92130
Re: K143337
Trade/Device Name: CONELOG® Titanium base CAD/CAM Regulation Number: 21 CFR 872.4630 Regulation Name: Endosseous dental implant abutment Regulatory Class: Class II Product Code: NHA Dated: November 19, 2014 Received: November 20, 2014
Dear Ms. Schulz:
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
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 devicerelated 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 contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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,
Tina
Kiang -S
for Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosures
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Indications for Use
510(k) Number (if known) K143337
Device Name
CONELOG® Titanium base CAD/CAM
Indications for Use (Describe)
CONELOG® Titanium base CAD/CAM
-
Implant-prosthetic titanium abutment for CONELOG® implants with connection, as a bonding base for hybrid abutments.
-
The Titanium base CAD/CAM for implant Ø 3.3 mm is designed only for hybrid abutments in the area of the upper lateral incisors and lower central and lateral incisors.
Type of Use (Select one or both, as applicable)
|X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary Altatec GmbH CONELOG® Titanium base CAD/CAM
February 12, 2015
ADMINISTRATIVE INFORMATION
Manufacturer Name: | Altatec GmbH | |
---|---|---|
Maybachstrasse 5 | ||
D-71299 Wimsheim, Germany | ||
Telephone: | +49 7044 9445 0 | |
Fax: | +49 7044 9445 723 | |
Official Contact: | Dennis Pappas | |
Senior Quality Auditor/Regulatory Affairs | ||
(Henry Schein/CAMLOG USA) | ||
Representative/Consultant: | Linda K. Schulz, BSDH, RDH | |
Floyd G. Larson, MS, MBA | ||
PaxMed International, LLC | ||
12264 El Camino Real, Suite 400 | ||
San Diego, CA 92130 | ||
Telephone: | +1 (858) 792-1235 | |
Fax: | +1 (858) 792-1236 | |
Email: | lschulz@paxmed.com | |
flarson@paxmed.com |
DEVICE NAME AND CLASSIFICATION
Trade/Proprietary Name: | CONELOG® Titanium base CAD/CAM |
---|---|
Common Name: | Endosseous dental implant abutment |
Classification Name: | Endosseous dental implant abutment |
Classification Regulations: | 21 CFR 872.3630, Class II |
Product Code: | NHA |
Classification Panel: | Dental Products Panel |
Reviewing Branch: | Dental Devices Branch |
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INTENDED USE
CONELOG® Titanium base CAD/CAM
-
Implant-prosthetic titanium abutment for CONELOG® implants with conical abutment connection, as a bonding base for hybrid abutments.
-
The titanium base CAD/CAM for implant Ø3.3mm is designed only for hybrid abutments in the area of the upper lateral incisors and lower central and lateral incisors
DEVICE DESCRIPTION
CONELOG Titanium base CAD/CAM is an abutment designed to be used with the Sirona CAD/CAM System in Coris ZI meso L and meso S to fabricate a hybrid abutment with an angle up to 20°.The Titanium base CAD/CAM is available in four implant platform sizes (3.3 mm 3.8 mm, 4.3 mm, and 5.0 mm), two gingival heights (0.8 mm or 2.0 mm) and is supplied with the corresponding screw. All design parameters are according to the cleared Sirona CAD/CAM System parameters.
PERFORMANCE DATA
Non-clinical testing data submitted, referenced, or relied upon to demonstrate substantial equivalence included: static and dynamic compression-bending testing according to ISO 14801 Dentistry - Implants - Dynamic fatigue test for endosseous dental implants. Clinical data were not submitted in this premarket notification.
EQUIVALENCE TO MARKETED DEVICE
Altatec GmbH submits the following information in this Premarket Notification to demonstrate, for the purposes of FDA's regulation of medical devices, the subject device is substantially equivalent in indications and design principles to the following legally marketed predicate devices:
Altatec GmbH, iSy Implant System - K133991; Altatec GmbH, CONELOG® Implant System - K113779; Altatec GmbH, CAMLOG® Implant System Modified Implants and Abutments - K083496; and Sirona Dental Systems GmbH, Sirona Dental CAD/CAM System - K111421.
The primary predicated device for this submission is K133991. The subject device and the predicate devices encompass the same range of physical dimensions and characteristics, including implant diameter and length, and similar surface treatments. Any differences in the technological characteristics between the subject and predicate devices do not raise different issues of safety or effectiveness.
The data included in this submission demonstrate substantial equivalence to the predicate devices listed above.
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Overall, the subject device has the following similarities to the predicate devices:
- has the same intended use, .
- uses the same operating principle, .
- incorporates the same basic design, ●
- incorporates the same or very similar materials, and .
- has similar packaging and is sterilized using the same materials and processes. .