(89 days)
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.
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.
This document is a 510(k) summary for the CONELOG® Titanium base CAD/CAM. It describes the device, its intended use, and the data submitted to demonstrate substantial equivalence to legally marketed predicate devices.
1. A table of acceptance criteria and the reported device performance
The document does not specify quantitative acceptance criteria. Instead, it relies on performance testing designed to demonstrate mechanical integrity under relevant dental conditions.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Mechanical Integrity | Passed static and dynamic compression-bending testing according to ISO 14801. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify the exact sample size for the non-clinical testing. It only states that "non-clinical testing data submitted" was used. The provenance of the data (country of origin, retrospective/prospective) is not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This is a medical device submission for a physical implant component, not an AI or imaging-based diagnostic tool. Therefore, there is no "ground truth" in the diagnostic sense, and no experts were used to establish such. The "ground truth" for this type of device is its mechanical robustness and compliance with established standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as this is not an imaging or diagnostic study requiring adjudication for ground truth.
5. If a multi-reader, multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is a submission for a physical dental implant component, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a submission for a physical dental implant component, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" in this context is the successful completion of established mechanical performance tests (ISO 14801) designed to simulate in-vivo conditions. The device is expected to withstand specified static and dynamic forces without failure, demonstrating its structural integrity and safety.
8. The sample size for the training set
Not applicable. This is not a machine learning or AI-based device, so there is no training set in the conventional sense.
9. How the ground truth for the training set was established
Not applicable. See point 8.
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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.
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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. .
§ 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.)