(132 days)
No
The device description and performance studies focus on the physical characteristics, materials, and mechanical testing of dental abutments, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No.
This device is designed to support prosthetic restorations (dental implants) and does not inherently provide therapy for a disease or condition. Its function is structural support.
No
Explanation: The device is an abutment for screw-retained prosthetic restorations, which is a supportive component for dental implants. Its intended use as described is to "support occlusal screw-retained prosthetic restorations," indicating a therapeutic or restorative function, not a diagnostic one.
No
The device description clearly details physical components made of titanium alloy, indicating 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 clearly states that the abutments are "intended to support occlusal screw- retained prosthetic restorations in the upper jaw and lower jaw in conjunction with CAMLOG® and CONELOG® Implants." This describes a device used in vivo (within the body) for structural support of dental prosthetics.
- Device Description: The description details the physical characteristics, materials, and types of abutments, all of which are components designed for surgical implantation and mechanical function.
- 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 screening. The device itself is the implant component, not a tool for analyzing biological samples.
IVD devices are specifically designed to perform tests on biological samples outside of the body to provide diagnostic information. This device is a surgical implant component.
N/A
Intended Use / Indications for Use
CAMLOG® and CONELOG® Abutments for Screw-retained Restorations (ASR) are intended to support occlusal screw- retained prosthetic restorations in the upper jaw and lower jaw in conjunction with CAMLOG® and CONELOG® Implants.
Product codes (comma separated list FDA assigned to the subject device)
NHA
Device Description
Abutment for Screw-retained Restorations (ASR) is available with the Camlog or the Conelog implant/abutment interface. ASR Straight is provided in five platform diameters (3.3. 3.8. 4.3. 5.0 and 6.0 mm) and three gingival heights (0.5, 2.0 and 4.0 mm), for a total of 15 abutment options. ASR Angled is provided in four platform diameters (3.3, 3.8, 4.3, and 5.0 mm), four gingival heights (2.5, 3.5, 4.0 and 5.0 mm), and two angles (17° and 30°). Each of the angled designs is provided in a Type A option (anti-rotation cam alignment away from the abutment cone angle) or Type B option (anti-rotation cam alignment in the direction of the abutment cone angle), for a total of 32 abutment options. A healing cap, and a titanium cap for temporary or permanent restoration fabrication are available for all sizes. All ASR components are made from titanium alloy conforming to ASTM F136 Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Upper jaw and lower jaw (in conjunction with dental implants)
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)
Non-clinical testing data submitted, referenced, or relied upon to demonstrate substantial equivalence included: sterilization validation according to : ISO 11137-1 Sterilization of health care products -- Radiation -- Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices and ISO 11137-2 Sterilization of health care products -- Radiation -- Part 2: Establishing the sterilization dose, ISO 17665-1 Sterilization of health care products – Moist heat – Part 1: Requirements for the development, validation, and routine control of a sterilization process for medical devices; ISO 17665-2 Sterilization of health care products – Moist heat – Part 2: Guidance on the application of ISO 17665-1; ISO 10993-1 Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process, and 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.
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.
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.
K141871, K073553, K083496, K113779
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
Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features an abstract design of an eagle with three lines forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 12, 2016
ALTATEC GmbH c/o Ms. Linda K. Schulz Regulatory Affairs PaxMed International, LLC 12264 El Camino Real, Suite 400 San Diego, California 92130
Re: K152509
Trade/Device Name: CAMLOG® and CONELOG® Abutments For Screw-retained Restorations (ASR) Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: December 10, 2015 Received: December 11, 2015
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.
1
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
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name
CAMLOG® and CONELOG® Abutments for Screw-retained Restorations (ASR)
Indications for Use (Describe)
CAMLOG® and CONELOG® Abutments for Screw-retained Restorations (ASR) are intended to support occlusal screw- retained prosthetic restorations in the upper jaw and lower jaw in conjunction with CAMLOG® and CONELOG® Implants.
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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3
510(k) Summary
Altatec GmbH CAMLOG® and CONELOG® Abutments for Screw-retained Restorations (ASR)
January 11, 2016
ADMINISTRATIVE INFORMATION
| Manufacturer Name | Altatec GmbH
Maybachstrasse 5
D-71299 Wimsheim, Germany | | | |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------|--|--|
| | Telephone: | +49 7044 9445 0 | | |
| | Fax: | +49 7044 9445 723 | | |
| Official Contact | Colleen Boswell
Director of RA/QA Ortho Organizers, Inc. | | | |
| 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 | CAMLOG® and CONELOG® Abutments for Screw-retained
Restorations (ASR) |
|----------------------------|-------------------------------------------------------------------------|
| 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 |
INTENDED USE
CAMLOG® and CONELOG® Abutments for Screw-retained Restorations (ASR) are intended to support occlusal screw-retained prosthetic restorations in the upper jaw and lower jaw in conjunction with CAMLOG® and CONELOG® Implants.
4
PREDICATE INFORMATION
The primary predicate device is K133421.
Reference Predicates
K141871 - Straumann® Screw Retained Abutments K073553 - CAMLOG Implant System Abutments K083496 - CAMLOG Implant System Modified Implants and Abutments K113779 - CONELOG® Implant System
DEVICE DESCRIPTION
Abutment for Screw-retained Restorations (ASR) is available with the Camlog or the Conelog implant/abutment interface. ASR Straight is provided in five platform diameters (3.3. 3.8. 4.3. 5.0 and 6.0 mm) and three gingival heights (0.5, 2.0 and 4.0 mm), for a total of 15 abutment options. ASR Angled is provided in four platform diameters (3.3, 3.8, 4.3, and 5.0 mm), four gingival heights (2.5, 3.5, 4.0 and 5.0 mm), and two angles (17° and 30°). Each of the angled designs is provided in a Type A option (anti-rotation cam alignment away from the abutment cone angle) or Type B option (anti-rotation cam alignment in the direction of the abutment cone angle), for a total of 32 abutment options. A healing cap, and a titanium cap for temporary or permanent restoration fabrication are available for all sizes. All ASR components are made from titanium alloy conforming to ASTM F136 Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401).
PERFORMANCE DATA
Non-clinical testing data submitted, referenced, or relied upon to demonstrate substantial equivalence included: sterilization validation according to : ISO 11137-1 Sterilization of health care products -- Radiation -- Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices and ISO 11137-2 Sterilization of health care products -- Radiation -- Part 2: Establishing the sterilization dose, ISO 17665-1 Sterilization of health care products – Moist heat – Part 1: Requirements for the development, validation, and routine control of a sterilization process for medical devices; ISO 17665-2 Sterilization of health care products – Moist heat – Part 2: Guidance on the application of ISO 17665-1; ISO 10993-1 Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process, and 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.
5
EQUIVALENCE TO MARKETED DEVICE
The subject device is substantially equivalent in indications and design principles predicate devices shown above. Below are summary tables showing technical comparison between the subject device and the primary predicate devices.
| Indications for Use | |
|---|---|
| Subject Device | |
| Altatec Gmbh |
CAMLOG® and
CONELOG® Abutments
for Screw-retained
Restorations (ASR) | CAMLOG® and CONELOG® Abutments for Screw-retained Restorations (ASR)
are intended to support occlusal screw-retained prosthetic restorations in the upper
jaw and lower jaw in conjunction with CAMLOG® and CONELOG® Implants. |
| Primary Predicate Device | |
| Straumann USA, LLC
Straumann® Magellan™
Abutment System
K133421 | The Straumann® Magellan™ abutments are indicated to be placed into Straumann®
dental implants to provide support for prosthetic reconstructions such as crowns,
bridges and bars.
The final processed devices have the purpose of restoring chewing function.
Magellan™ abutments are indicated for screw-retained restorations. |
| | Subject
Device | Primary
Predicate | Reference Predicate Devices | | |
|-----------------------------------------|----------------------------------------------------------------------------------------|-----------------------------------------------|----------------------------------------------|------------------------------------------|-------------------------------|
| | Altatec Gmbh | Straumann
USA, LLC | Straumann
USA, LLC | Altatec
GmbH | Altatec Gmbh |
| | CAMLOG®
and
CONELOG®
Abutments for
Screw-retained
Restorations
(ASR) | Straumann®
Magellan™
Abutment
System | Straumann®
Screw
Retained
Abutments | CAMLOG
Implant
System
Abutments | CONELOG®
Implant
System |
| | | K133421 | K141871 | K073553 | K113779 |
| Design | | | | | |
| Prosthesis
Attachment | Screw-retained | Screw-retained | Screw-retained | Screw-retained | Screw-retained |
| Abutment
Platform
Diameter,
mm | 3.3 - 6.0 | 3.5 - 4.6 | 4.6 | 3.3 - 6.0 | 3.3 - 5.0 |
| Abutment
Angle | Straight to 30° | Straight to 30° | Straight to
30° | Straight to
20° | Straight to
20° |
| Material | | | | | |
| Abutment | Ti-6AL-4V
ELI | Ti-6AL-7Nb | Ti-6AL-7Nb | Ti-6AL-4V
ELI | Ti-6AL-4V
ELI |
6
Abutment for Screw-retained Restorations (ASR) is substantially equivalent to the predicate devices in K133421 and K141871. K133421 is the primary predicate having straight and angled abutments (17° and 30°), multiple gingival heights (1.0 - 4.0 mm) and Type A and B indexing orientations. Straumann® Screw Retained Abutments K141871 adds angled abutments for the NC diameter implant. Both ASR and Straumann Screw-retained Abutment have a titanium cap designed for temporary or permanent restorations. The subject device and primary predicate have slightly different Indications for Use language. However, the difference in language does not change the intended use of abutments. Both abutments are being used in conjunction with dental implants for the purpose of supporting screw-retained dental prostheses.
CONCLUSIONS
The subject device and the predicate devices have intended use, have similar technological characteristics, and are made of similar materials. The subject device and predicate devices encompass the same range of physical dimensions, including length, diameter, height, and angle of the abutment. The subject and predicate devices are packaged in similar materials and sterilized using similar methods.
The data included in this submission demonstrate substantial equivalence to the predicate devices listed above.