(91 days)
No
The device description and performance studies focus on the physical characteristics and biocompatibility of dental abutments, with no mention of AI or ML.
No
The device is described as an abutment used to fabricate prosthetic restorations in conjunction with dental implants, which supports prostheses. This function is restorative and supportive, not therapeutic in the sense of treating a disease or condition.
No
The device description clearly states its purpose is to "fabricate prosthetic restorations" and support "prostheses," which are treatment-oriented functions, not diagnostic ones.
No
The device description clearly describes physical abutments made of titanium, which are hardware components.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the abutments are used to fabricate prosthetic restorations in conjunction with implants to support prostheses in the mouth (maxillary and/or mandibular arch). This is a mechanical/structural function within the body.
- Device Description: The description details the physical characteristics of the abutments (straight, material, dimensions, interfaces). This aligns with a medical device used for physical support.
- 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) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (within the body) as part of a dental restoration.
N/A
Intended Use / Indications for Use
CAMLOG® and CONELOG®
CAMLOG® and CONELOG® Abutments are intended to be used to fabricate prosthetic restorations in conjunction with CAMLOG® and CONELOG® implants to support prostheses in the maxillary and/or mandibular arch.
iSy®
iSy® Abutments are intended to be used to fabricate prosthetic restorations in conjunction with iSy 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
Abutment for Bridges is a straight abutment designed for multi-unit, cement-retained restorations. It is available with two gingival heights (0.8 and 2.0 mm) for CONELOG and iSy and one gingival height for CAMLOG.
Abutment for Bridges is available for CAMLOG, CONELOG and iSy Implant Systems. It is available in five CAMLOG platform diameters (3.3 mm, 4.3 mm, 5.0 mm, and 6.0 mm), four CONELOG platform diameters (3.3 mm, 3.8 mm, 4.3 mm and 5.0 mm), and one iSy interface connection.
The Temporary Abutment is a straight, one-piece titanium abutment for cement-retained provisional restorations. It is available in a non-indexed bridge version for CAMLOG, CONELOG and iSy, and an indexed crown version for CAMLOG implant system.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
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)
Non-clinical testing data submitted, referenced, or relied upon to demonstrate substantial equivalence included: sterilization validation according to 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, and ISO 10993-1 Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process, and reference to the applicant's own predicate devices in K113779, K133991, and K0823496 for demonstration of biocompatibility.
Overall, the subject device has 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 to be sterilized using the same processes.
The data included in this submission demonstrate substantial equivalence to the predicate devices listed above.
No clinical data were included in this submission.
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.
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 logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol representing the human form, depicted as three overlapping profiles facing to the right.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 31, 2016
ALTATEC GmbH c/o Ms. Linda Schultz Regulatory Affairs PaxMed International, LLC 12264 El Camino Real, Suite 400 San Diego, California 92130
Re: K153779
Trade/Device Name: Abutment for Bridges Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous dental implant abutment Regulatory Class: II Product Code: NHA Dated: December 30, 2015 Received: December 31, 2015
Dear Ms. Schultz:
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
Page 2 - Ms. Linda Schultz:
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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 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
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name
Abutment for Bridges
Indications for Use (Describe)
CAMLOG® and CONELOG®
CAMLOG® and CONELOG® Abutments are intended to be used to fabricate prosthetic restorations in conjunction with CAMLOG® and CONELOG® implants to support prostheses in the maxillary and/or mandibular arch.
iSy®
iSy® Abutments are intended to be used to fabricate prosthetic restorations in conjunction with iSy implants to support prostheses in the maxillary and/or mandibular arch.
Type of Use (Select one or both, as applicable)
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
Abutment for Bridges
March 30, 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, Henry Schein | |
| 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 | Abutment for Bridges |
|---|---|
| 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 |
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510(k) Summary Page 2 of 4
PREDICATE INFORMATION
Primary Predicate ALTATEC GmbH, CONELOG® Implant System - K113779 Reference Predicates ALTATEC GmbH, iSy® Implant System - K133991 ALTATEC GmbH, CAMLOG Implant System Modified Implants and Abutments - K083496
INTENDED USE
CAMLOG® and CONELOG®
CAMLOG® and CONELOG® Abutments are intended to be used to fabricate prosthetic restorations in conjunction with CAMLOG® and CONELOG® implants to support prostheses in the maxillary and/or mandibular arch.
iSy®
iSy Abutments are intended to be used to fabricate prosthetic restorations in conjunction with iSy implants to support prostheses in the maxillary and/or mandibular arch.
DEVICE DESCRIPTION
Abutment for Bridges is a straight abutment designed for multi-unit, cement-retained restorations. It is available with two gingival heights (0.8 and 2.0 mm) for CONELOG and iSy and one gingival height for CAMLOG.
Abutment for Bridges is available for CAMLOG, CONELOG and iSy Implant Systems. It is available in five CAMLOG platform diameters (3.3 mm, 4.3 mm, 5.0 mm, and 6.0 mm), four CONELOG platform diameters (3.3 mm, 3.8 mm, 4.3 mm and 5.0 mm), and one iSy interface connection.
The Temporary Abutment is a straight, one-piece titanium abutment for cement-retained provisional restorations. It is available in a non-indexed bridge version for CAMLOG, CONELOG and iSy, and an indexed crown version for CAMLOG implant system.
PERFORMANCE DATA
Non-clinical testing data submitted, referenced, or relied upon to demonstrate substantial equivalence included: sterilization validation according to 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, and ISO 10993-1 Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process, and reference to the applicant's own predicate devices in K113779, K133991, and K0823496 for demonstration of biocompatibility.
No clinical data were included in this submission.
5
EQUIVALENCE TO MARKETED DEVICE
Abutment for Bridges is equivalent to the abutments in K113779 and K083496. They are straight abutments designed for cement retained restorations. The primary design difference is that the Abutment for Bridges has no anti-rotation feature in the implant/abutment connection or on the post for restoration.
Temporary Abutment is equivalent to the temporary abutment in K113779. The primary difference is that the Temporary Abutment has no anti-rotation feature because it is a multi-unit abutment.
| Subject Device | Primary Predicate Device | |
|---|---|---|
| ALTATEC GmbH Abutment for Bridges | ||
| K153779 | ALTATEC GmbH CONELOG® Implant System | |
| K113779 | ||
| Indications for Use | CAMLOG® and CONELOG® | |
| CAMLOG® and CONELOG® Abutments are intended to | ||
| be used to fabricate prosthetic restorations in conjunction | ||
| with CAMLOG® and CONELOG® implants to support | ||
| prostheses in the maxillary and/or mandibular arch. |
iSy®
iSy Abutments are intended to be used to fabricate
prosthetic restorations in conjunction with iSy® implants
to support prostheses in the maxillary and/or mandibular
arch. | Implant Indications for Use
CONELOG® Implant System Implants are intended for immediate
or delayed placement in the bone of the maxillary or mandibular
arch. CONELOG® Implant System Abutments are intended for
use as support for crowns, bridges or overdentures. When a one- stage surgical approach is applied, the implant may be
immediately loaded when good primary stability is achieved and
the functional load is appropriate.
CONELOG® Implants with 3.3 mm diameter have the following
additional specific indications:
These are an alternative in cases where the alveolar ridge width
is only 5 – 6 mm. Because of their lower mechanical strength
compared with larger diameter implants, they should only be
used under the following conditions:
As single implants, they should be used only to replace mandibular incisors and/or maxillary lateral incisors. An edentulous arch can only be restored with a bar retained superstructure with at least four implants of 3.3 mm diameter without distal extensions. Implants of Ø 3.3 mm are suitable for a partially edentulous arch when combined with implants of larger diameter for |
| | | splinted superstructures. However, the limited strength of the
implants with Ø 3.3 mm must be taken into account.
Avoid excessive mechanical stressing of the implants when using ball abutments in combination with Ø 3.3 mm implants The healing time for Ø 3.3 mm implants is at least 12 weeks.
CONELOG® Implants with 7 mm length have the following
additional specific indications:
CONELOG® SCREW-LINE Implants should only be used
when there is not enough space for a longer implant. Delayed
loading in single tooth replacement is indicated with these
implants. If the ratio of crown length to implant length is
unfavorable the biomechanical risk factors have to be considered
and appropriate measures have to be taken by the dental
professional. |
| | | Abutment Indications for Use
CONELOG® Abutments are intended to be used to fabricate
prosthetic restorations in conjunction with CONELOG implants to
support prostheses in the maxillary and/or mandibular arch. |
| | | Vario SR Indications for Use
CONELOG® Vario SR components for crown and bridge
restorations:
Occlusal screw-retained crown, bridge and bar constructions on CONELOG® implants in the anterior and posterior region of the maxilla and mandible
CONELOG® Vario SR components for bar restorations:
Anchorage of implant-supported full dentures for the edentulous maxilla in conjunction with 4 or more CONELOG® implants and in the edentulous mandible in conjunction with 2 or 4 or more CONELOG® implants. |
| | Subject Device | Primary Predicate Device |
| | ALTATEC GmbH Abutment for Bridges | ALTATEC GmbH CONELOG® Implant System |
| | K153779 | K113779 |
| Design | | |
| Abutment/Implant
Diameter, mm | 3.3, 3.8, 4.3, 4.4, 5.0, 6.0 | 3.3, 3.8, 4.3, 5.0 |
| Abutment Angle | Straight | Up to 20° |
| Restoration | Cement-retained | Screw-retained, Cement-retained |
| Material | | |
| Abutments and
Abutment Screw | Ti-6Al-4V ELI | Ti-6Al-4V ELI |
6
The Indications for Use for the subject device differs from the identified primary predicate in that the submission device Indications for Use is a sub-set of the Indications for Use of the primary predicate. This does not change the intended use of the subject device as compared to the predicate because the subject device, a dental abutment, is a subset of the primary predicate, a complete implant system. The intended use of the subject device is similar to the intended use of the dental abutments cleared in the primary predicate.
Implant/abutment interfaces for CAMLOG, CONELOG and iSy subject device abutments are similar to the corresponding predicate device Implant Systems as identified in the primary and reference predicate devices. However, the lack of an anti-rotation feature does not affect the fit of the abutment to the corresponding implant and is further mitigated by the limitation of the Abutment for Bridges and non-indexed Temporary Abutment devices as multi-unit abutments.
CONCLUSION
Overall, the subject device has 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 to be sterilized using the same processes.
The data included in this submission demonstrate substantial equivalence to the predicate devices listed above.