(68 days)
CAMLOG® Vario SR components for crown and bridge restorations:
- Occlusal screw-retained crown, bridge and bar constructions on CAMLOG® implants (with J and K article numbers) in the anterior and posterior region of the maxilla and mandible
CAMLOG® Vario SR components for bar restorations: - Anchorage of implant-supported full dentures for the edentulous maxilla and mandible in combination with 2, 4 or more CAMLOG® implants (with J and K article numbers)
CAMLOG® Vario SR Abutments are titanium dental implant abutments for use with the CAMLOG® Dental Implant System. They have an internal connection to the implant, a conical interface with the prosthetic attachment, and are used for single and multi-unit screw-retained, prefabricated restorations. They are appropriate for supporting laboratory cast frameworks as well as laser-welded bar constructions and have dedicated prosthetic components.
The provided text describes the 510(k) summary for Altatec GmbH CAMLOG® Vario SR Abutments. This is a medical device submission, and the information requested pertains to the evaluation of AI/ML-driven medical devices. Unfortunately, the provided document does not contain any information about an AI/ML-driven device or its performance evaluation.
Instead, the document details a traditional medical device (dental implant abutments) and its substantial equivalence to other legally marketed predicate devices. The "testing" mentioned refers to mechanical testing according to ISO 14801 for static and dynamic fatigue properties of the physical device.
Therefore, I cannot provide a table of acceptance criteria, reported device performance, or details about studies involving sample sizes, ground truth establishment, expert adjudication, or MRMC studies, as these concepts are not applicable to the content provided.
I can, however, extract the relevant "testing" information for this specific device from the provided text, which focuses on mechanical performance:
Acceptance Criteria and Device Performance (for mechanical properties of the physical device):
| Acceptance Criteria Category | Specific Criteria/Standard | Reported Device Performance | Study Details |
|---|---|---|---|
| Mechanical Strength | ISO 14801 Dentistry - Implants - Dynamic fatigue test for endosseous dental implants | "Results of fatigue testing confirmed the strength of the system." | Mechanical testing was performed. No specific numerical results or sample sizes for this testing are provided in the summary. |
Regarding the other requested information (AI/ML specific details):
- Sample size used for the test set and the data provenance: Not applicable as the device is not AI/ML-driven.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
- 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.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. The "ground truth" for this device would be its physical strength and material properties.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
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u ・
510(k) Summary
JAN 1 0 2011
.
Altatec GmbH CAMLOG® Vario SR Abutments January 3, 2011
ADMINISTRATIVE INFORMATION
| Manufacturer Name: | Altatec GmbH |
|---|---|
| Maybachstrasse 5 | |
| D-71299 Wimsheim, Germany | |
| Telephone: +49 7044 9445 0 | |
| Fax: +49 7044-9445 723 | |
| Official Contact: | Tina Steffanie-Oak |
| CAMLOG USA | |
| Telephone: +1 (717) 335-7230 | |
| Fax: +1 (717) 335-7240 | |
| Email: Tina.Steffanie-Oak@henryschein.com | |
| Representative/Consultant: | Linda K. Schulz, BSDH, RDH |
| Kevin A Thomas, PhD | |
| PaxMed International, LLC | |
| 11234 El Camino Real, Suite 200 | |
| San Diego, CA 92130 | |
| Telephone: +1 (858) 792-1235 | |
| Fax: +1 (858) 792-1236 | |
| Email: lschulz@paxmed.com |
DEVICE NAME AND CLASSIFICATION
| Trade/Proprietary Name: | CAMLOG® Vario SR Abutments |
|---|---|
| Common Name: | Dental implant abutments |
| Classification Regulations: | Endosseous dental implant abutment21 CFR 872.3630, Class II |
| Product Code: | NHA |
| Classification Panel: | Dental Products Panel |
| Reviewing Branch: | Dental Devices Branch |
INTENDED USE
CAMLOG® Vario SR components for crown and bridge restorations:
- Occlusal screw-retained crown, bridge and bar constructions on CAMLOG® implants (with J u and K article numbers) in the anterior and posterior region of the maxilla and mandible
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CAMLOG® Vario SR components for bar restorations:
- Anchorage of implant-supported full dentures for the edentulous maxilla and mandible in ■ combination with 2, 4 or more CAMLOG® implants (with J and K article numbers)
DEVICE DESCRIPTION
CAMLOG® Vario SR Abutments are titanium dental implant abutments for use with the CAMLOG® Dental Implant System. They have an internal connection to the implant, a conical interface with the prosthetic attachment, and are used for single and multi-unit screw-retained, prefabricated restorations. They are appropriate for supporting laboratory cast frameworks as well as laser-welded bar constructions and have dedicated prosthetic components.
EQUIVALENCE TO MARKETED DEVICE
Altatec GmbH demonstrated that, for the purposes of FDA's regulation of medical devices CAMLOG® Vario SR Abutments are substantially equivalent in indications and design principles to the following predicate devices, each of which has been determined by FDA to be substantially equivalent to pre-amendment devices:
- . Nobel Biocare USA LLC, Multi-Unit Abutments for Astra Tech, Camlog and Ankylos Implant Systems, cleared under K061477;
- Nobel Biocare USA LLC, Procera Titanium Abutment for Astra Tech and Camlog Implant . Systems, cleared under K061478;
- Nobel Biocare USA LLC, Procera® Implant Bridge, cleared under K043042; .
- Nobel Biocare USA LLC, Procera® Abutment Brånemark, cleared under K042658; .
- Thommen Medical AG, SPI® VARIOmulti Abutment, cleared under K072856; .
- Thommen Medical AG, SPI® VARIOmulti Angled Abutment, cleared under K090153; and .
- Thommen Medical AG, SPI® VARIOmulti Angled Abutment, cleared under K101798. .
TESTING
Mechanical testing was performed according to ISO 14801 Dentistry - Implants - Dynamic fatigue test for endosseous dental implants to ensure that the strength of the CAMLOG Vario SR Abutments in conjunction with CAMLOG implants are appropriate for its intended use. Results of fatigue testing confirmed the strength of the system.
Overall, CAMLOG® Vario SR Abutments have 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 .
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around the perimeter. Inside the circle is an image of an eagle with its wings spread, with three lines representing the wings. The eagle is facing to the right.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Altatec GMBH C/O Ms. Linda Schulz Regulatory Affairs PaxMed International, LLC 11234 El Camino Real, Suite 200 San Diego, California 92130
JAN 1 0 201
Re: K103252
Trade/Device Name: CAMLOG® Vario SR Abutments Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: January 3, 2011 Received: January 4, 2011
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 mav, 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 be found in the Code of Federal Regulations, Title 21, Parties 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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Page 2- Ms. Schulz
Enclosure
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 (2) 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 vours.
Nh 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
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Page 1 of 1 510(k) Summary
Indications for Use
K103252 510(k) Number:
JAN 1 0 2011
CAMLOG® Vario SR Abutments Device Name:
Indications for Use:
CAMLOG® Vario SR components for crown and bridge restorations:
- Occlusal screw-retained crown, bridge and bar constructions on CAMLOG® implants (with J 트 and K article numbers) in the anterior and posterior region of the maxilla and mandible CAMLOG® Vario SR components for bar restorations:
- Anchorage of implant-supported full dentures for the edentulous maxilla and mandible in . combination with 2, 4 or more CAMLOG® implants (with J and K article numbers)
Prescription Use X (Part 21 CFR 801 Subpart D)
Over-The-Counter Use AND/OR (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)
Page 1 of
Susan Rubase
(Division Sign-Off)
Division of Anesthesiology, General Hospital
Infection Control, Dental Devices
510(k) Number:
§ 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.)