(101 days)
Not Found
Not Found
No
The document describes a prosthetic system for dental implants and does not mention any AI or ML components or capabilities.
No
The device is described as a prosthetic system used to fabricate crowns and bridges in conjunction with dental implants, which is a restorative rather than a therapeutic function.
No
The device is described as a prosthetic system used to fabricate crowns and bridges, which is a treatment or restorative function, not a diagnostic one.
No
The device description explicitly lists physical components such as dental implant abutments, screws, impression caps, analogs, and plastic burn-out copings, indicating it is a hardware-based system, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to fabricate crowns and bridges in conjunction with dental implants to support prostheses. This is a mechanical and structural function within the body, not a diagnostic test performed on samples taken from the body.
- Device Description: The device components (abutments, screws, impression caps, analogs, copings) are all related to the physical process of creating and supporting dental prosthetics. They are not designed to analyze biological samples for diagnostic purposes.
- Lack of IVD Characteristics: There is no mention of analyzing blood, urine, tissue, or any other biological sample. There is no mention of detecting diseases, conditions, or physiological states through in vitro analysis.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device clearly falls outside of that definition.
N/A
Intended Use / Indications for Use
The CAMLOG Logfit™ Prosthetic System is 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
NHA
Device Description
The CAMLOG Logfit Prosthetic System includes dental implant abutments and screws intended to be used to support cement retained crowns and bridges in conjunction with Camlog dental implants in the maxillary and/or mandibular arch. The system also includes impression caps, analogs and plastic, burn-out copings, (Class I exempt, not a part of this submission), intended to facilitate the preparation of prosthetic restorations.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
maxillary and/or mandibular arch
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
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
K071213
510(k) Summary
CAMLOG Logfit™ Prosthetic System
AUG 1 0 2007
ADMINISTRATIVE INFORMATION
| Manufacturer Name: | Altatec GmbH
Maybachstrasse 5
D-71299 Wimsheim, Germany
Telephone +49 7044 9445-0
Fax +49 7044 9445-722 |
|----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Official Contact: | Tina Steffanie-Oak
CAMLOG USA
Telephone 1 (717) 335-7230 x4150
Fax 1 (717) 335-7240
email: Tina.Steffanie-Oak@henryschein.com |
| Representative/Consultant: | Floyd G. Larson
PaxMed International, LLC
11234 El Camino Real, Suite 200
San Diego, CA 92130
Telephone 1 (858) 792-1235
Fax 1 (858) 792-1236
email: flarson@paxmed.com |
DEVICE NAME AND CLASSIFICATION
| Trade/Proprietary Name: | CAMLOG Logfit™ Prosthetic System |
|---|---|
| Common Name: | dental abutments |
| Classification Regulation: | Endosseous dental implant abutment |
| (21 CFR 872.3630), Class II | |
| Product Codes | NHA |
DEVICE CLASSIFICATION PANEL
The Classification Panel for this device is the Dental Products Panel, and it is reviewed by the Dental Devices Branch.
1
INTENDED USE
KC 71213
The CAMLOG Logfit™ Prosthetic System is 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 Logfit Prosthetic System includes dental implant abutments and screws intended to be used to support cement retained crowns and bridges in conjunction with Camlog dental implants in the maxillary and/or mandibular arch. The system also includes impression caps, analogs and plastic, burn-out copings, (Class I exempt, not a part of this submission), intended to facilitate the preparation of prosthetic restorations.
EQUIVALENCE TO MARKETED PRODUCT
Altatec GmbH has demonstrated that, for the purposes of FDA's regulation of medical devices, the CAMLOG Logfit Prosthetic System is 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.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" are arranged in a circular pattern around the caduceus symbol. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 0 2007
Altatec GmbH Mr. Floyd G. Larson President PaxMed International, LLC 11234 El Camino Real, Suite 200 San Diego, California 92130
Re: K071213
Trade/Device Name: CAMLOG Logfit™ Prosthetic System Regulation Number: 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: July 30, 2007 Received: July 31, 2007
Dear Mr. Larson:
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 such 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 - Mr. Larson
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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Clare
Chiu Lin. Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): _ КО 7 121 3
Device Name: CAMLOG Logfit™ Prosthetic System
Indications for Use:
The CAMLOG Logfit™ Prosthetic System is intended to be used to fabricate crowns and bridges in conjunction with CAMLOG dental implants to support prostheses in the naxillary 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)
(Division Sign-Off)
Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices
E10(k) Number: K071213