(358 days)
No
The document describes a dental implant system and its components, focusing on mechanical design and intended use. There is no mention of AI or ML technology in the intended use, device description, or performance studies.
No
The device is an implant system used for supporting crowns, bridges, or overdentures, primarily serving a restorative purpose rather than a therapeutic one.
No
The device described is an implant system (implants and abutments) used for dental restoration, not for diagnosing medical conditions. Its purpose is to replace missing teeth, not to identify diseases or conditions.
No
The device description clearly details physical implants and abutments made of materials, indicating it is a hardware medical device, not software-only.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as an implant system for placement in bone and abutments for supporting dental prostheses. This is a surgical and prosthetic device, not a diagnostic one.
- Device Description: The description focuses on the physical design and components of the implant system, including the interface, materials, and different types of abutments. This aligns with a medical device used for treatment or restoration, not diagnosis.
- Lack of Diagnostic Function: There is no mention of the device being used to test samples (blood, tissue, etc.) or to provide information about a patient's health status or disease.
- Anatomical Site: The anatomical site is the maxillary or mandibular arch, which is where dental implants are surgically placed.
- Intended User: The intended user is a "dental professional," which is consistent with a surgical and prosthetic device.
In vitro diagnostics are devices used to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device does not fit that description.
N/A
Intended Use / Indications for Use
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.
- A void excessive mechanical stressing of the implants when using ball abutments in combination . with 0 3.3 mm implants.
- The healing time for 0 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.
Product codes (comma separated list FDA assigned to the subject device)
DZE, NHA
Device Description
The purpose of this submission is to add an alternative to the CAMLOG® Implant System by the introduction of an implant line with a tapered implant abutment interface. The new line of implants and abutments is named the CONELOG® Implant System. The primary features of the current CAMLOG Implant System are a change from the tube-in-tube interface with a square cam design for anti-rotation to the tapered implant/abutment interface connection with three positioning cams and the addition of a 7.0 mm long implant. The three positioning cams of the CONELOG abutments are placed more apically on the abutment shaft but are comparable in design principle to the three positioning cams of the CAMLOG Implant System. All other design features of the system remain the same.
The CONELOG implant system features an implant/abutment interface that includes a 7.5° taper with anti-rotation cams at the base of the connection. Components available with the CONELOG implant/abutment interface include the SCREW-LINE Promote® plus implant and cover screw, healing caps, Universal abutments, Telescope abutments, Esthomic" abutments, the Esthomice abutment inset, temporary abutments, Gold-plastic abutments, Logfit® abutments, ball abutments, bar abutments and Vario SR abutments. All components correspond to previously cleared CAMLOG components with the tube-in-tube interface.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
maxillary or mandibular arch
Indicated Patient Age Range
Not Found
Intended User / Care Setting
dental professional
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)
Mechanical testing, including static and dynamic compression-bending testing, has been perfomed according to ISO 14801 Dentistry - Implants - Dynamic fatigue test for endosseous dental implants.
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.
K083496, K103252, K051636, K063779, K011028, K063341, K101849
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
§ 872.3640 Endosseous dental implant.
(a)
Identification. An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.(b)
Classification. (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. 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.)(2)
Classification. Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use;
(ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads;
(iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system;
(iv) The device must be demonstrated to be biocompatible;
(v) Sterility testing must demonstrate the sterility of the device;
(vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment;
(vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians;
(viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and
(ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.
0
510(k) Summary Altatec GmbH CONELOG® Implant System K113779
November 20, 2012
ADMINISTRATIVE INFORMATION
Manufacturer Name:
Altatec GmbH Maybachstrasse 5 D-71299 Wimsheim, Germany Telephone: +49 7044 9445 0 +49 7044-9445 723 Fax:
Official Contact:
Representative/Consultant:
Tina Steffanie-Oak Senior Regulatory Affairs Specialist, CAMLOG USA
Linda K. Schulz, BSDH, RDH Kevin A Thomas, PhD PaxMed International, LLC 11234 El Camino Real, Suite 200 San Diego, CA 92130 Telephone: +1 (858) 792-1235 +1 (858) 792-1236 Fax: Email: lschulz@paxmed.com kthomas@paxmed.com
DEVICE NAME AND CLASSIFICATION
Trade/Proprietary Name: Common Names:
Classification Name:
Classification Regulations: Product Codes:
Classification Panel: Reviewing Branch:
CONELOG® Implant System Dental implants and dental implant abutments
Implant, Endosseous, Root-form Abutment, Implant, Dental, Endosseous
21 CFR 872.3640, 21 CFR 872.3630, Class II DZE, NHA
Dental Products Panel Dental Devices Branch DEC 1 4 2012
1
510(k) Summary K113779
INTENDED USE
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.
DEVICE DESCRIPTION
The purpose of this submission is to add an alternative to the CAMLOG® Implant System by the introduction of an implant line with a tapered implant abutment interface. The new line of implants and abutments is named the CONELOG® Implant System. The primary features of the current CAMLOG Implant System are a change from the tube-in-tube interface with a square cam design for anti-rotation to the tapered implant/abutment interface connection with three positioning cams and the addition of a 7.0 mm long implant. The three positioning cams of the CONELOG abutments are placed more apically
2
510(k) Summary K113779
on the abutment shaft but are comparable in design principle to the three positioning cams of the CAMLOG Implant System. All other design features of the system remain the same.
The CONELOG implant system features an implant/abutment interface that includes a 7.5° taper with anti-rotation cams at the base of the connection. Components available with the CONELOG implant/abutment interface include the SCREW-LINE Promote® plus implant and cover screw, healing caps, Universal abutments, Telescope abutments, Esthomic" abutments, the Esthomice abutment inset, temporary abutments, Gold-plastic abutments, Logfit® abutments, ball abutments, bar abutments and Vario SR abutments. All components correspond to previously cleared CAMLOG components with the tube-in-tube interface.
EQUIVALENCE TO MARKETED DEVICES
Altatec GmbH has demonstrated that, for the purposes of FDA's regulation of medical devices, the CONELOG® Implant System is substantially equivalent in indications and design principles to the following predicate devices:
Altatec GmbH, CAMLOG Implant System Modified Implants and Abutments cleared under K083496; Altatec GmbH, CAMLOG® VarioSR Abutments cleared under K103252;
Altatec GmbH, Altatec CAMLOG Abutments and Healing Caps cleared under K051636;
Astra Tech, Inc., OsseoSpeed™ 4.0S - 6 mm cleared under K063779,
Sulzer Dental, Inc., Screw-Vent Dental Implant System cleared under K011028,
Implant Innovations, Inc., OSSEOTITE® Certain® Dental Implants cleared under K063341,
Bicon, LLC., Ø3.0 x 8 mm and Ø3.0 x 11 mm Bicon Implant 3.0mm cleared under K 101849.
The CONELOG Implant System is an additional implant line to the CAMLOG Implant System using a tapered implant/abutment interface. A tapered implant/abutment interface is used for the Astra Tech implant system cleared under K063779 and many other implants that are cleared for marketing in the United States. Other than the interface and the addition of a 7.0 mm length implant, all the components of the CONELOG system have the same design and material as those cleared under, K083496, K 103252 and K051636. The 7.0 mm implant is similar in design and length to the Astra Tech OsseoSpeed 4.0S - 6 mm, having a tapered connection and a treated surface. Other design features of the 7.0 mm implant are the same as the other implants in the CONELOG Implant System.
Mechanical testing, including static and dynamic compression-bending testing, has been perfomed according to ISO 14801 Dentistry - Implants - Dynamic fatigue test for endosseous dental implants.
In conclusion, the data included in this submission demonstrates substantial equivalence to the predicate devices listed above.
Overall, the CONELOG Implant System 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 sterilized using the same materials and processes. .
3
Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines forming its body and wings. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement. The text is in all caps and appears to be in a sans-serif font.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 14, 2012
0
Altatec GmbH C/O Ms. Linda K. Schulz, BSDH, RDH PaxMed International, Limited Liability Company 11234 El Camino Real, Suite 200 SAN DIEGO CA 92130
Re: K113779
Trade/Device Name: Conelog® Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE, NHA Dated: December 7, 2012 Received: December 10, 2012
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.
4
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/CentersOffices/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/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,
12012.12.14 Susan Runner DDS, MAN 11:48:37 -05.00,
Anthony D. Watson, B.S., M.S., M.B.A. Director
Division of Anesthesiology, General Hospital, Respiratory, Infection Control and
Dental Devices
Office of Device Evaluation
Center for Devices and Radiological Health
Enclosure
5
510(k) Summary K113779
Indications for Use
510(k) Number: K113779
CONELOG® Implant System Device Name:
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.
- A void excessive mechanical stressing of the implants when using ball abutments in combination . with 0 3.3 mm implants.
- The healing time for 0 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.
X Prescription Use (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)
Page 1 of 2
Susan Runner DDS, MA
2012.12.14
11:47:54 -05'00'
(Division Sign-Off) Division of Anesthesialogy, General Hospital Infaction Control, Dental Devices
510{k) Number:_
6
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.
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)
Page 2 of 2
2012.12.14
Susan Runner DDS, MAS 11:48:16
-05'00'
(Division Sign-Off) (Division Sign-Off)
Division of Anesthesiology, General Hospital
Division of Anesthesiology, General Devices Division of Ansol. Dental Devices
510(k) Number;