(78 days)
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No
The summary describes standard dental implant abutments and does not mention any AI or ML capabilities, image processing, or performance studies related to algorithmic analysis.
No.
The device, CAMLOG Implant System Abutments, is intended to support prostheses (crowns and bridges) in dental implants, which is a supportive and restorative function, not a therapeutic one (i.e., treating or alleviating a disease or condition).
No
The device, CAMLOG Implant System Abutments, is described as supporting prostheses (crowns and bridges) in dental implants. Its intended use is to fabricate these prostheses, which is a treatment or restorative function, not a diagnostic one. There is no mention of it identifying, detecting, or measuring any physiological or pathological conditions.
No
The device description explicitly states it covers a series of abutments, which are physical components used in dental implants. This indicates it is a hardware device, 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 CAMLOG dental implants to support prostheses in the maxillary and/or mandibular arch." This describes a device used in vivo (within the body) for structural support and restoration, not for testing samples in vitro (outside the body) to diagnose conditions.
- Device Description: The description details abutments, which are components that connect a dental implant to a prosthesis. This aligns with a surgical/restorative device, not a diagnostic one.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting markers, or providing diagnostic information.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device's function is purely mechanical and structural within the patient's mouth.
N/A
Intended Use / Indications for Use
CAMLOG Implant System Abutments 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
This submission covers a series of abutments for the CAMLOG Implant System, including a straight crown and bridge abutment, a prepable abutment, a conical abutment, a cast-on abutment, and a temporary abutment.
Mentions image processing
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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
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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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.
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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.
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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).
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§ 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
43553
CAMLOG Implant System Abutments
510(k) Summary
MAR - 5 2008
Altatec GmbH CAMLOG Implant System Abutments
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 | |
| Fax: +1 (717) 335-7240 | |
| Email: Tina.Steffanie-Oak@henryschein.com | |
| Representative/Consultant: | 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: lschulz@paxmed.com | |
| flarson@paxmed.com |
DEVICE NAME AND CLASSIFICATION
| Trade/Proprietary Name: | CAMLOG Implant System Abutments |
|---|---|
| Common Name: | Dental implant abutments |
| Classification Regulations: | Endosseous dental implant abutment |
| 21 CFR 872.3630, Class II | |
| Product Codes | NHA |
| Classification Panel: | Dental Products Panel |
| Reviewing Branch: | Dental Devices Branch |
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INTENDED USE
CAMLOG Implant System Abutments 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
This submission covers a series of abutments for the CAMLOG Implant System, including a straight crown and bridge abutment, a prepable abutment, a conical abutment, a cast-on abutment, and a temporary abutment.
EQUIVALENCE TO MARKETED PRODUCT
Altatec GmbH demonstrated that, for the purposes of FDA's regulation of medical devices, CAMLOG Implant System Abutments 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.
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 eagle with its wings spread, surrounded by a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the top half of the circle. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Altatec GmbH C/O Ms. Linda K. Schulz Regulatory Affairs PaxMed International, LLC 11234 El Camino Real, Suite 200 San Diego, California 92130
MAR - 5 2008
Re: K073553
Trade/Device Name: CAMLOG Implant System Abutments Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: December 17, 2007 Received: December 18, 2007
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 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.
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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 liederal 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 (OS) 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,
Snytte y. Miakem Oms
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
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CAMLOG Implant System Abutments
Indications for Use
510(k) Number (if known):
CAMLOG Implant System Abutments Device Name:
Indications for Use:
CAMLOG Implant System Abutments 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)
Susan
(Division Sign-Off)
Division of Anesthesiology, General Hospital
Infection Control, Dental Devices
Page
510(k) Number:
C673532