(127 days)
Not Found
Not Found
No
The summary describes a mechanical dental abutment system and does not mention any software, algorithms, or AI/ML capabilities.
No
The device, CAMLOG® Abutments PS, is described as being used to fabricate crowns and bridges in conjunction with dental implants to support prostheses. This function is for structural support and restoration rather than for treating or preventing a disease, injury, or other condition, which is characteristic of a therapeutic device.
No
Explanation: The device is described as an abutment used to fabricate crowns and bridges in conjunction with dental implants, which is a restorative function, not a diagnostic one.
No
The device description explicitly states it includes "a series of permanent abutments, temporary abutments and healing caps," which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used to fabricate crowns and bridges in conjunction with dental implants to support prostheses. This is a direct therapeutic and restorative application within the body.
- Device Description: The description focuses on the physical components and their function in supporting dental prostheses.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used outside the body to analyze biological samples. This device is used inside the body as part of a dental restoration process.
N/A
Intended Use / Indications for Use
CAMLOG® Abutments PS are intended to be used to fabricate crowns and bridges in conjunction with CAMLOG dental implants to support prostheses in the maxillary and/or mandibular arch.
Product codes (comma separated list FDA assigned to the subject device)
NHA
Device Description
The CAMLOG Implant System CAMLOG Abutments PS (Platform Switching) allows the treatment option of using a smaller abutment interface diameter than the platform diameter of the implant. The system includes a series of permanent abutments, temporary abutments and healing caps.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
maxillary and/or mandibular arch
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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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
§ 872.3630 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
510(k) Summary
Altatec GmbH CAMLOG® Abutments PS
JUN 18 2009
ADMINISTRATIVE INFORMATION
Manufacturer-Name:
Official Contact:
Altatec GmbH Maybachstrasse 5 D-71299 Wimsheim, Germany Telephone: +49 7044 9445 0 Fax: +49 7044 9445 723
Tina Steffanie-Oak CAMLOG USA Telephone: +1 (717) 335-7230 Fax: +1 (717) 335-7240 Email: Tina.Steffanie-Oak@henryschein.com
Linda K. Schulz or Floyd G. Larson PaxMed International, LLC 11234 El Camino Real, Suite 200 San Diego, CA USA 92130 Telephone: +1 (858) 792-1235 Fax: +1 (858) 792-1236 Email: Ischulz@paxmed.com flarson@paxmed.com
DEVICE NAME AND CLASSIFICATION
Trade/Proprietary Name: Common Name: Classification Regulations:
Representative/Consultant:
Product Code: Classification Panel: Reviewing Branch:
CAMLOG® Abutments PS Dental implant abutments Endosseous dental implant abutment 21 CFR 872.3630, Class II NHA Dental Products Panel Dental Devices Branch
1
510(k) Summary
INTENDED USE
CAMLOG® Abutments PS are intended to be used to fabricate crowns and bridges in conjunction with CAMLOG dental implants to support prostheses in the maxillary and/or mandibular arch.
DEVICE DESCRIPTION
The CAMLOG Implant System CAMLOG Abutments PS (Platform Switching) allows the treatment option of using a smaller abutment interface diameter than the platform diameter of the implant. The system includes a series of permanent abutments, temporary abutments and healing caps.
EQUIVALENCE TO MARKETED PRODUCT
Altatec GmbH demonstrated that, for the purposes of FDA's regulation of medical devices, CAMLOG Abutments PS are substantially equivalent in indications and design principles to predicate devices, each of which has been determined by FDA to be substantially equivalent to preamendment devices.
Overall, the CAMLOG Abutments PS have the following similarities to the predicate devices:
- I use the same operating principle,
- incorporate the same basic design,
- I incorporate the same materials, and
- 트 are packaged and sterilized using the same materials and processes.
In summary, CAMLOG Abutments PS described in this submission are, in our opinion, substantially equivalent to the predicate devices.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/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 its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circle around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.
Public Health Service
JUN 18 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Altatec GmbH C/O Linda K. Schulz, RDH, BSDH Senior Regulatory Affairs Specialist PaxMed International, LLC 11234 El Camino Real, Suite 200 San Diego, California 92130
Re: K090347
Trade/Device Name: CAMLOG® Abutments PS Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: May 26, 2009 Received: May 27, 2009
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.
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.
3
Page 2- Ms. Schulz
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/Centers Offices/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/cdrh/mdr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Susan Punner
Susan Runner, D.D.S., M.A. Acting Division Director Division of Anesthesiology, General Hospital. Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Summary
Indications for Use
510(k) Number (if known):
CAMLOG® Abutments PS Device Name:
Indications for Use:
CAMLOG® Abutments PS are intended to be used to fabricate crowns and bridges in conjunction with CAMLOG dental implants to support prostheses in the maxillary and/or mandibular arch.
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)
| Kei Harley for VSC | |
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| Division of Anesthesiology, General Hospital | |
| Infection Control, Dental Devices |
| 510(k) Number: | K090347 |
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