(298 days)
No
The document describes a physical dental implant and its materials, manufacturing, and testing. There is no mention of software, algorithms, or any technology that would suggest the use of AI or ML.
Yes
The device, CAMLOG®/CONELOG® PROGRESSIVE-LINE implants, is explicitly described as being "intended for the restoration of edentulous and partially edentulous jaws with prosthetic restorations" and serving as "anchors for functional and esthetic oral rehabilitations." These descriptions fall under the definition of therapeutic intervention, as they are designed to correct a medical condition (edentulousness) and restore function.
No
Explanation: This document describes dental implants, which are used for restoration and implantation, not for diagnosing medical conditions.
No
The device description clearly states that the device is a physical, screw-form endosseous dental implant made of titanium. It is surgically placed in bone and serves as an anchor for prosthetic restorations. This is a hardware device, not software.
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 a dental implant for surgical placement in the jawbone to support prosthetic restorations. This is a surgical and restorative function, not a diagnostic one.
- Device Description: The device is described as a titanium screw-form endosseous dental implant. This is a physical implant, not a reagent, instrument, or system intended for use in vitro to examine specimens from the human body.
- Lack of IVD Characteristics: 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 through in vitro analysis.
The device is a medical device, specifically a dental implant, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
CAMLOG®/CONELOG® PROGRESSIVE-LINE implants are intended for the restoration of edentulous and partially edentulous jaws with prosthetic restorations such as implant-supported single crowns, bridges and full dentures. Specifically for:
- · single-tooth gaps,
- · partially edentulous jaws with several missing teeth or
- · edentulous jaws.
CAMLOG®/CONELOG® PROGRESSIVE-LINE implants are suitable for oral endosseous implantation in the maxillary and/or mandibular bone and are intended for immediate or delayed implantation. They are indicated for transgingival healing (one-stage, using healing caps or abutments) or subgingival healing (two-stage, using cover screws). If single-phase healing is intended, the implants can be loaded immediately if the primary stability achieved is adequate for functional loading. In conjunction with the corresponding abutments, the implants can be used for screw-retained or cemented restorations such as single crowns, bridges and full dentures.
CAMLOG®/CONELOG® PROGRESSIVE-LINE Implants with a diameter of 3.3 mm have the following additional specific indications:
Implants with a diameter of 3.3 mm are indicated as an alternative in cases where the alveolar ridge width is only 5-6 mm. Because of their lower tensile 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 diameter 3.3 mm implants is at least 12 weeks.
CONELOG® implants with 7 mm length have the following additional specific indications:
These 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.
Product codes (comma separated list FDA assigned to the subject device)
DZE
Device Description
The CONELOG® PROGRESSIVE-LINE Implants and the CAMLOG® PROGRESSIVE-LINE Implants represent an extension of the range of implants which are based on the welldocumented technology used for implants offered by CAMLOG Biotechnologies GmbH / Altatec GmbH.
Altatec GmbH CAMLOG®CONELOG® PROGRESSIVE-LINE Implants are titanium (CPTi Grade 4), screw-form endosseous dental implants and have a conical outer geometry in the apical area. The outer implant surface is abrasive-blasted and acid-etched - medium rough surface (Promote® surface structure). The implant shoulder of the CONELOG®/CAMLOG® PROGRESSIVE-LINE implants is machined. CAMLOG®/CONELOG® PROGRESSIVE-LINE Implants are supplied in different diameters and lengths (See Table 1. below).
The Altatec GmbH CAMLOG®/CONELOG® PROGRESSIVE-LINE Implants are placed surgically in the maxillary and/or mandibular bone and serve as anchors for functional and esthetic oral rehabilitations in partially and fully edentulous patients. The prosthetic rehabilitation is carried out with single crowns, bridges, or full arch prostheses, which are fastened to the implants by corresponding secondary parts (i.e. abutments).
The implant-abutment connection consists either of a Tube-in-Tube™ configuration with three cams for abutment positioning and rotational stability (CAMLOG® PROGRESSIVE-LINE) or an inner conical section and an indexing section with three cams for abutment positioning and as an antirotational mechanism (CONELOG® PROGRESSIVE-LINE). This means that the respective implant-abutment connections are identical to the connections of the respective equivalent systems (i.e. CONELOG®/CAMLOG® prosthetic product lines).
CAMLOG® CONELOG® PROGRESSIVE-LINE Implants are intended for one stage (transgingival / non-submerged) or two stage (submerged) protocols. The CONELOG® PROGRESSIVE-LINE implants are placed at bone level (epicrestally) and the CAMLOG® PROGRESSIVE-LINE implants are placed 0.4mm supracrestally. The CAMLOG®CONELOG® PROGRESSIVE-LINE Implants are made of the same implant grade material as the predicate devices (commercially pure titanium. CPTi Grade 4. meeting the requirements of ASTM F67-13. Standard Specification for Unalloyed Titanium for Surgical Implant Applications).
The product is packaged using materials known in the industry to be appropriate for medical device packaging and is provided with a minimum sterility assurance level of 10°, validated in compliance with ISO 11137-1 Sterilization of healthcare products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
maxillary and/or mandibular bone
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)
Dynamic mechanical fatigue testing was performed on the CAMLOG® PROGRESSIVE-LINE and CONELOG® PROGRESSIVE-LINE utilizing the smallest implant body diameters (3.3 mm and 3.8 mm) and 13 mm implant lengths. The 13 mm-length implants were tested due to having sufficient length for proper fixation in compliance with ISO 14801. Dentistry - Implants -Dynamic fatigue test for endosseous dental implants. The applicable abutment connection (i.e. CONELOG® or CAMLOG®), in a Universal abutment configuration or a Bar abutment (30° angled) configuration, was utilized with the CAMLOG® PROGRESSIVE-LINE implant or the CONELOG® PROGRESSIVE-LINE implant during the dynamic mechanical fatigue testing. The testing mechanical benchmarks (acceptance criterion) for fatigue testing of the CAMLOG®CONELOG® PROGRESSIVE-LINE Implants were based on the substantially equivalent predicate devices (CAMLOG® SCREW-LINE / ROOT-LINE Promote® & Promote® plus; CONELOG® SCREW-LINE Promote®) and they met the requirement regarding mechanical integrity demonstrating the strength of the PROGRESSIVE-LINE implants is appropriate for their intended use and is substantially equivalent to that of the predicate devices (K113779 & K083496).
Sterilization validation was performed on the gamma sterilization process. The sterilization validation was conducted on representative worst-case Altatec GmbH dental implant device (i.e. reference predicate device - K083496, CAMLOG® SCREW-LINE implant - Promote® plus). The requirements of ISO 11137-1. ISO 11137-2, and ISO 11137-3 were met with regard to the validation of the sterilization procedure of the product family CAMLOG®/CONELOG® SCREW-LINE and CAMLOG® ROOT-LINE. The sterilization testing demonstrates the compliance with the required minimum 'aamma radiation dose of 25 kGv and a maximum of 50 kGy (according to ISO 11137-3) for sterilization of CAMLOG®/CONELOG® Implants packaged by Altatec GmbH (the primary predicate device (K113779) and the reference predicate device (K083496) for the Progressive-Line Implants).
Tests for endotoxins are performed and non-endotoxin pyrogens evaluated according to the FDA Guidance on "Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile." The subject devices are submitted to a validated cleaning process within the manufacturing process. Manufacturing processes are analogous for all dental implants consisting of titanium grade 4 manufactured by Altatec GmbH. The cleaning process is identical for all of these implants including predicate devices (K113779 & K083496). The effectivity of the cleaning process for the implants is revalidated once per quarter of the year. To detect endotoxin levels on the finished implants, the Limulus Amebocyte Lysate (LAL) test is performed using the gel-clot technique, as per United States Pharmacopoeia (USP) 38-NF33, chapter 85, and the ANSI/AAMI ST72, within every revalidation. The endotoxin limit was derived from USP 38-NF33, chapter 161, "Transfusion and Infusion Assemblies and Similar Devices", that states, "For medical devices, the endotoxin limit is not more than 20.0 USP Endotoxin Units per device except that for those medical devices in contact with the cerebrospinal fluid ... "
Accelerated, artificial ading was accomplished for shelf life in accordance with ISO 11607-1. Packaging for Terminally Sterilized Medical Devices - Part-1, and ASTM F1980, Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices. Shelf life has been established to be five years provided the sterile seal is not breached. The device is a titanium (CPTi Grade 4), non-mechanical, non-active device, therefore, degradation in performance characteristics will not occur over the established shelf life period. Special storage conditions are not required for the device, as ambient storage conditions will not adverselv affect the safety or efficacy of the device.
A biological evaluation according to ISO 10993-1, Biological Evaluation of Medical Devices - Part-1, was completed for the PROGRESSIVE-LINE Implants. From the testing, the biological evaluation for the PROGRESSIVE-LINE implants indicated that the remalning risk regarding biocompatibility could be considered low and therefore acceptable. Test results concluded that the test articles were non-cytotoxic, non-irritating and negative for evidence of dermal sensitization under the test conditions employed and substantially equivalent to the predicate devices (K113779 & K083496).
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
§ 872.3640 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
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
September 29, 2020
Altatec GmbH % Bill Hornbuckle Regulatory Affairs Associate II BioHorizons Implant Systems, Inc. 2300 Riverchase Center Birmingham, Alabama 35244
Re: K193401
Trade/Device Name: Altatec GmbH CAMLOG®/CONELOG® PROGRESSIVE-LINE Implants Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE Dated: August 28, 2020 Received: August 31, 2020
Dear Bill Hornbuckle:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
for Srinivas Nandkumar, Ph.D. Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K193401
Device Name
Altatec GmbH CAMLOG® / CONELOG® PROGRESSIVE-LINE Implants
Indications for Use (Describe)
CAMLOG®/CONELOG® PROGRESSIVE-LINE implants are intended for the restoration of edentulous and partially edentulous jaws with prosthetic restorations such as implant-supported single crowns, bridges and full dentures. Specifically for:
- · single-tooth gaps,
- · partially edentulous jaws with several missing teeth or
· edentulous jaws.
CAMLOG®/CONELOG® PROGRESSIVE-LINE implants are suitable for oral endosseous implantation in the maxillary and/or mandibular bone and are intended for immediate or delayed implantation. They are indicated for transgingival healing (one-stage, using healing caps or abutments) or subgingival healing (two-stage, using over screws). If singlephase healing is intended, the implants can be loaded immediately if the primary stability achieved is adequate for functional loading. In conjunction with the corresponding abutments, the implants can be used for screw-retained or cemented restorations such as single crowns, bridges and full dentures.
CAMLOG®/CONELOG® PROGRESSIVE-LINE Implants with a diameter of 3.3 mm have the following additional specific indications:
Implants with a diameter of 3.3 mm are indicated as an alternative in cases where the alveolar ridge width is only 5-6 mm. Because of their lower tensile 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 diameter 3.3 mm implants is at least 12 weeks.
CONELOG® implants with 7 mm length have the following additional specific indications: These 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.
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
3
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4
510(k) Summarv 21 CFR 807.92
Submitter's Name & Address
| Manufacturer: | Altatec GmbH
Maybachstrasse 5
Wimsheim, Germany D-71299
Phone +49 7044 9445 0
Fax +49 7044 9445 723 |
|-------------------|-----------------------------------------------------------------------------------------------------------------|
| Official contact: | Reto Pusterla, Head, Regulatory Affairs |
| Date prepared: | September 29 2020 |
Application Correspondent's Name & Address
| Correspondent: | BioHorizons Implant Systems, Inc.
2300 Riverchase Center
Birmingham, AL 35244
Phone (205) 967-7880
Fax (205) 870-0304 |
|-------------------|-----------------------------------------------------------------------------------------------------------------------------------|
| Official contact: | Bill Hornbuckle, Regulatory Affairs Associate I |
| Date prepared: | September 29 2020 |
Name of the Device
| Trade Name: | Altatec GmbH CAMLOG® / CONELOG® PROGRESSIVE-
LINE Implants |
|------------------------|---------------------------------------------------------------|
| Common or Usual Name: | Screw-type dental implant |
| Classification Name: | Endosseous dental implant |
| Classification Number: | Class II (21 CFR 872.3640) |
Predicate Devices
Primary Predicate Device:
-
K113779, Altatec GmbH CONELOG® Implant System, December 14, 2012 .
Reference Predicate Device: -
K083496, Altatec GmbH CAMLOG® Implant System Modified Implants and Abutments, . January 30, 2009
Device Description
The CONELOG® PROGRESSIVE-LINE Implants and the CAMLOG® PROGRESSIVE-LINE Implants represent an extension of the range of implants which are based on the welldocumented technology used for implants offered by CAMLOG Biotechnologies GmbH / Altatec GmbH.
Altatec GmbH CAMLOG®CONELOG® PROGRESSIVE-LINE Implants are titanium (CPTi Grade 4), screw-form endosseous dental implants and have a conical outer geometry in the apical area. The outer implant surface is abrasive-blasted and acid-etched - medium rough surface (Promote® surface structure). The implant shoulder of the CONELOG®/CAMLOG® PROGRESSIVE-LINE implants is machined. CAMLOG®/CONELOG® PROGRESSIVE-LINE Implants are supplied in different diameters and lengths (See Table 1. below).
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| Implant | Diameter | Length |
|---|---|---|
| CONELOG® PROGRESSIVE-LINE | 3.3 mm | 9/11/13/16 mm |
| Promote® plus | 3.8/4.3/5.0 mm | 7/9/11/13/16 mm |
| CAMLOG® PROGRESSIVE-LINE | 3.3 mm | 11/13/16 mm |
| Promote® plus | 3.8/4.3/5.0 mm | 9/11/13/16 mm |
| Table 1 |
NOTE: The term PROGRESSIVE-LINE refers to the implant body shape, whereas the terms CONELOG® or CAMLOG® refer to the implant-abutment connection designs.
The Altatec GmbH CAMLOG®/CONELOG® PROGRESSIVE-LINE Implants are placed surgically in the maxillary and/or mandibular bone and serve as anchors for functional and esthetic oral rehabilitations in partially and fully edentulous patients. The prosthetic rehabilitation is carried out with single crowns, bridges, or full arch prostheses, which are fastened to the implants by corresponding secondary parts (i.e. abutments).
The implant-abutment connection consists either of a Tube-in-Tube™ configuration with three cams for abutment positioning and rotational stability (CAMLOG® PROGRESSIVE-LINE) or an inner conical section and an indexing section with three cams for abutment positioning and as an antirotational mechanism (CONELOG® PROGRESSIVE-LINE). This means that the respective implant-abutment connections are identical to the connections of the respective equivalent systems (i.e. CONELOG®/CAMLOG® prosthetic product lines).
CAMLOG® CONELOG® PROGRESSIVE-LINE Implants are intended for one stage (transgingival / non-submerged) or two stage (submerged) protocols. The CONELOG® PROGRESSIVE-LINE implants are placed at bone level (epicrestally) and the CAMLOG® PROGRESSIVE-LINE implants are placed 0.4mm supracrestally. The CAMLOG®CONELOG® PROGRESSIVE-LINE Implants are made of the same implant grade material as the predicate devices (commercially pure titanium. CPTi Grade 4. meeting the requirements of ASTM F67-13. Standard Specification for Unalloyed Titanium for Surgical Implant Applications).
The product is packaged using materials known in the industry to be appropriate for medical device packaging and is provided with a minimum sterility assurance level of 10°, validated in compliance with ISO 11137-1 Sterilization of healthcare products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices.
Indications for Use
CAMLOG®/CONELOG® PROGRESSIVE-LINE implants are intended for the restoration of edentulous and partially edentulous jaws with prosthetic restorations such as implant-supported single crowns, bridges and full dentures. Specifically for:
- · single-tooth gaps,
- · partially edentulous jaws with several missing teeth or
- · edentulous jaws.
CAMLOG®/CONELOG® PROGRESSIVE-LINE implants are suitable for oral endosseous implantation in the maxillary and/or mandibular bone and are intended for immediate or delayed implantation. They are indicated for transgingival healing (one-stage, using healing caps or abutments) or subgingival healing (two-stage, using cover screws). If single-phase healing is intended, the implants can be loaded immediately if the primary stability achieved is adequate for functional loading. In conjunction with the corresponding abutments, the implants can be used for screw-retained or cemented restorations such as single crowns, bridges and full dentures.
6
CAMLOG®/CONELOG® PROGRESSIVE-LINE Implants with a diameter of 3.3 mm have the following additional specific indications:
Implants with a diameter of 3.3 mm are indicated as an alternative in cases where the alveolar ridge width is only 5-6 mm. Because of their lower tensile 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 diameter 3.3 mm implants is at least 12 weeks.
CONELOG® implants with 7 mm length have the following additional specific indications:
These 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.
Technological Characteristics
The CAMLOG® PROGRESSIVE-LINE / CONELOG® PROGRESSIVE-LINE Implants represent self-tapping implants with an outer geometry consisting of a coronal cylindrical portion and a conical apical portion. The CAMLOG® PROGRESSIVE-LINE Implants and the CONELOG® PROGRESSIVE-LINE Implants are available with the Promote® surface structure (Promote® / Promote® plus) which has a roughness Ra of typically 1.3 um. The Promote® surface is achieved by abrasive sand blasting of machined titanium and subsequent acid etching. The shape and the surface structure (i.e. Promote® / Promote® plus) of the CAMLOG®/CONELOG® PROGRESSIVE-LINE Implants are substantially equivalent to that of the primary predicate device (K113779) and the reference predicate device (K083496).
The CONELOG® PROGRESSIVE-LINE implants feature the identical implant-abutment connection as CONELOG® SCREW-LINE implants (primary predicate device - K113779), allowing the use of exactly the same secondary parts for the prosthetic suprastructure. The implant abutment connection consists of the conical part and an index part with a groovelcam design (positioned apically). More apically, there is an inner thread for the abutment screw. The same thread is also used for the fixation of cover screws, healing abutments, bar and ball abutments, Locator® abutments, and insertion posts. The implant material and surface texture (Promote®) are identical to the predicate devices. The main difference is in the thread design in order to achieve good primary stability in bone.
The CAMLOG® PROGRESSIVE-LINE implants feature the identical Tube-in-Tube™ implantabutment connection (i.e. inner configuration with three square grooves) as CAMLOG® SCREW-LINE or ROOT-LINE implants (reference predicate device - K083496), allowing the use of exactly the same secondary parts for the prosthetic suprastructure.
The CAMLOG® PROGRESSIVE-LINE and CONELOG® PROGRESSIVE-LINE Implants have a color code for the implant system for an easy identification of the prosthetic platform diameter.
7
The basic design principles of the CAMLOG®CONELOG® PROGRESSIVE-LINE Implants are adapted from the CAMLOG®/CONELOG® SCREW-LINE & CAMLOG® ROOT-LINE implant systems (primary and reference predicate devices). For details on substantial equivalence. refer to Table 2 of this summary.
Although the wording in the Indications for Use is not identical between the subject devices and the predicate devices, the content is substantially equivalent for the subject devices and the primary predicate device (K11379). In both cases the subject and predicate devices are intended for surgical placement in the maxillary and/or mandibular bone for the purpose of attaching a dental prosthesis and include shared features (Refer to Table 2 of this summary) which demonstrate substantial equivalence in their respective designs. The totality of the preceding description and the mechanism of action as tested indicates that there is no substantial difference between the subject devices and the primary predicate device (K113779) with respect to either indications for use or technological characteristics. The proposed devices do not pose any new or increased risks as compared to the legally marketed predicate devices based on the performance evaluation conducted on the worst-case manufactured dimensions which supports the determination that the subject devices are appropriate for their intended use and do not render the devices not substantially equivalent.
Summary of Testing
Dynamic mechanical fatigue testing was performed on the CAMLOG® PROGRESSIVE-LINE and CONELOG® PROGRESSIVE-LINE utilizing the smallest implant body diameters (3.3 mm and 3.8 mm) and 13 mm implant lengths. The 13 mm-length implants were tested due to having sufficient length for proper fixation in compliance with ISO 14801. Dentistry - Implants -Dynamic fatigue test for endosseous dental implants. The applicable abutment connection (i.e. CONELOG® or CAMLOG®), in a Universal abutment configuration or a Bar abutment (30° angled) configuration, was utilized with the CAMLOG® PROGRESSIVE-LINE implant or the CONELOG® PROGRESSIVE-LINE implant during the dynamic mechanical fatigue testing. The testing mechanical benchmarks (acceptance criterion) for fatigue testing of the CAMLOG®CONELOG® PROGRESSIVE-LINE Implants were based on the substantially equivalent predicate devices (CAMLOG® SCREW-LINE / ROOT-LINE Promote® & Promote® plus; CONELOG® SCREW-LINE Promote®) and they met the requirement regarding mechanical integrity demonstrating the strength of the PROGRESSIVE-LINE implants is appropriate for their intended use and is substantially equivalent to that of the predicate devices (K113779 & K083496).
Sterilization validation was performed on the gamma sterilization process. The sterilization validation was conducted on representative worst-case Altatec GmbH dental implant device (i.e. reference predicate device - K083496, CAMLOG® SCREW-LINE implant - Promote® plus). The requirements of ISO 11137-1. ISO 11137-2, and ISO 11137-3 were met with regard to the validation of the sterilization procedure of the product family CAMLOG®/CONELOG® SCREW-LINE and CAMLOG® ROOT-LINE. The sterilization testing demonstrates the compliance with the required minimum 'aamma radiation dose of 25 kGv and a maximum of 50 kGy (according to ISO 11137-3) for sterilization of CAMLOG®/CONELOG® Implants packaged by Altatec GmbH (the primary predicate device (K113779) and the reference predicate device (K083496) for the Progressive-Line Implants).
Tests for endotoxins are performed and non-endotoxin pyrogens evaluated according to the FDA Guidance on "Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile." The subject devices are submitted to a validated cleaning process within the manufacturing process. Manufacturing processes are analogous for all dental implants consisting of titanium grade 4 manufactured by Altatec GmbH. The cleaning process is identical for all of these implants including predicate devices (K113779
8
& K083496). The effectivity of the cleaning process for the implants is revalidated once per quarter of the year. To detect endotoxin levels on the finished implants, the Limulus Amebocyte Lysate (LAL) test is performed using the gel-clot technique, as per United States Pharmacopoeia (USP) 38-NF33, chapter 85, and the ANSI/AAMI ST72, within every revalidation. The endotoxin limit was derived from USP 38-NF33, chapter 161, "Transfusion and Infusion Assemblies and Similar Devices", that states, "For medical devices, the endotoxin limit is not more than 20.0 USP Endotoxin Units per device except that for those medical devices in contact with the cerebrospinal fluid ... "
Accelerated, artificial ading was accomplished for shelf life in accordance with ISO 11607-1. Packaging for Terminally Sterilized Medical Devices - Part-1, and ASTM F1980, Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices. Shelf life has been established to be five years provided the sterile seal is not breached. The device is a titanium (CPTi Grade 4), non-mechanical, non-active device, therefore, degradation in performance characteristics will not occur over the established shelf life period. Special storage conditions are not required for the device, as ambient storage conditions will not adverselv affect the safety or efficacy of the device.
The CAMLOG®/CONELOG® PROGRESSIVE-LINE Implants are made of the same implant grade material as the predicate devices (commercially pure titanium, CPTi Grade 4), meeting the requirements of ASTM F67-13. The abutment screws and abutments are made of a titanium alloy (Ti6Al4V ELI) which is listed in ASTM F136-13 and is the same material utilized by the predicate devices for the same items. The same manufacturing, cleaning, packaging, and sterilization processes are used for the evaluated devices, the primary predicate device (K113779) and the reference predicate device (K083496). A biological evaluation according to ISO 10993-1, Biological Evaluation of Medical Devices - Part-1, was completed for the PROGRESSIVE-LINE Implants. From the testing, the biological evaluation for the PROGRESSIVE-LINE implants indicated that the remalning risk regarding biocompatibility could be considered low and therefore acceptable. Test results concluded that the test articles were non-cytotoxic, non-irritating and negative for evidence of dermal sensitization under the test conditions employed and substantially equivalent to the predicate devices (K113779 & K083496).
Conclusion
The data presented in this submission demonstrates that the proposed devices are substantially equivalent to the primary predicate device with respect to performance and intended use. The proposed devices perform as well as the legally marketed predicate device. Furthermore, the proposed devices do not pose any new or increased risks as compared to the legally marketed predicate device.
9
Table 2: Summary Table of Substantial Equivalence
:
| | Subject Device | Subject Device | Primary Predicate
Device | Reference Predicate
Device | Reference Predicate
Device | |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | CONELOG®
PROGRESSIVE-LINE | CAMLOG®
PROGRESSIVE-LINE | CONELOG® SCREW-
LINE,
Promote®
K113779 | CAMLOG® SCREW-
LINE,
Promote® &
Promote® plus
K083496 | CAMLOG® ROOT-
LINE,
Promote® &
Promote® plus
K083496 | EQUIVALENCE DISCUSSION |
| General | | | | | | |
| Images | Image: CONELOG® PROGRESSIVE-LINE | Image: CAMLOG® PROGRESSIVE-LINE | Image: CONELOG® SCREW-LINE, Promote® K113779 | Image: CAMLOG® SCREW-LINE, Promote® & Promote® plus K083496 | Image: CAMLOG® ROOT-LINE, Promote® & Promote® plus K083496 | Threaded Implant Body, All |
| Clinical
Condition
When Used | partial or full
edentulism | partial or full
edentulism | partial or full
edentulism | partial or full
edentulism | partial or full
edentulism | Same for All |
| Site of Body | both jaws
(maxilla and/or
mandible) | both jaws
(maxilla and/or
mandible) | both jaws
(maxilla and/or
mandible) | both jaws
(maxilla and/or
mandible) | both jaws
(maxilla and/or
mandible) | Same for All |
| Intended Use | functional and / or
esthetical oral
rehabilitation of
partially or fully
edentulous patients | functional and / or
esthetical oral
rehabilitation of
partially or fully
edentulous patients | functional and / or
esthetical oral
rehabilitation of
partially or fully
edentulous patients | functional and / or
esthetical oral
rehabilitation of
partially or fully
edentulous patients | functional and / or
esthetical oral
rehabilitation of
partially or fully
edentulous patients | Same for All |
| Indications | CONELOG®
PROGRESSIVE-LINE
implants are indicated
for the restoration of
edentulous and partially
edentulous jaws with
prosthetic restorations | CAMLOG®
PROGRESSIVE-LINE
implants are indicated
for the restoration of
edentulous and
partially edentulous
jaws with prosthetic | CONELOG® Implant
System Implants are
intended for immediate
or delayed placement
in the bone of the
maxillary or mandibular
arch. CONELOG® | CAMLOG® Implant
System implants are
intended for immediate
or delayed placement
in the bone of the
maxillary or mandibular
arch. CAMLOG® | CAMLOG® Implant
System implants are
intended for
immediate or delayed
placement in the bone
of the maxillary or
mandibular arch. | Substantially Equivalent
Although the wording in the
Indications for Use are not
identical between the subject
devices and the predicate
devices, the content is |
| Subject Device | Subject Device | Primary Predicate
Device | Reference Predicate
Device | Reference Predicate
Device | EQUIVALENCE DISCUSSION | |
| CONELOG®
PROGRESSIVE-LINE | CAMLOG®
PROGRESSIVE-LINE | CONELOG® SCREW-
LINE,
Promote®
K113779 | CAMLOG® SCREW-
LINE,
Promote® &
Promote® plus
K083496 | CAMLOG® ROOT-
LINE,
Promote® &
Promote® plus
K083496 | | |
| such as implant-
supported single
crowns, bridges and full
dentures. Specifically
for:
• single-tooth gaps,
• partially edentulous
jaws with several
missing teeth or
• edentulous jaws.
CONELOG®
PROGRESSIVE-LINE
Implants are suitable for
oral endosseous
implantation in the
maxillary and/or
mandibular bone and
are intended for
immediate or delayed
implantation. They are
indicated for
transgingival healing
(one-stage, using
healing caps or
abutments) or
subgingival healing
(two-stage, using cover
screws). If single-phase
healing is intended, the
implants can be loaded
immediately if the
primary stability
achieved is adequate
for functional loading. In
conjunction with the
corresponding
abutments, the implants
can be used for screw-
retained or cemented
restorations such as
single crowns, bridges
and full dentures. | restorations such as
implant-supported
single crowns, bridges
and full dentures.
Specifically for:
• single-tooth gaps,
• partially edentulous
jaws with several
missing teeth or
• edentulous jaws.
CAMLOG®
PROGRESSIVE-LINE
Implants are suitable
for oral endosseous
implantation in the
maxillary and/or
mandibular bone and
are intended for
immediate or delayed
implantation. They are
indicated for
transgingival healing
(one-stage, using
healing caps or
abutments) or
subgingival healing
(two-stage, using cover
screws). If single-
phase healing is
intended, the implants
can be loaded
immediately if the
primary stability
achieved is adequate
for functional loading.
In conjunction with the
corresponding
abutments, the
implants can be used
for screw-retained or
cemented restorations
such as single crowns, | 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 | 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. | CAMLOG® 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. | substantially equivalent for the
subject devices and the primary
predicate device (K113779).
The Indications for Use of the
reference predicate devices
(K083496) and the subject
devices share the general
indications that are
corresponding with that of both
the subject devices and the
primary predicate device
(K113779).
In both cases the subject and
predicate devices are intended
for surgical placement in the
maxillary and/or mandibular
bone for the purpose of attaching
a dental prosthesis. The totality
of the preceding description and
the mechanism of action as
tested indicates that there is no
substantial difference between
the subject devices and the
primary predicate device
(K113779) with respect to either
indications for use or
technological characteristics.
The proposed devices do not
pose any new or increased risks
as compared to the legally
marketed predicate devices.
Both the subject devices and
predicate devices include shared
features, as provided in this
Summary Table of Substantial
Equivalence, which thereby
demonstrates substantial
equivalence in their respective
designs. Any specific
differences related to implant
shape, body diameter, external | |
| | bridges and full | without distal | | | thread design and prosthetic | |
| Subject Device | Subject Device | Primary Predicate
Device | Reference Predicate
Device | Reference Predicate
Device | EQUIVALENCE DISCUSSION | |
| CONELOG®
PROGRESSIVE-LINE | CAMLOG®
PROGRESSIVE-LINE | CONELOG® SCREW-
LINE,
Promote®
K113779 | CAMLOG® SCREW-
LINE,
Promote® &
Promote® plus
K083496 | CAMLOG® ROOT-
LINE,
Promote® &
Promote® plus
K083496 | | |
| Implants with a
diameter of 3.3 mm are
indicated as an
alternative in cases
where the alveolar ridge
width is only 5-6 mm.
Because of their lower
tensile 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. | dentures.
Implants with a
diameter of 3.3 mm are
indicated as an
alternative in cases
where the alveolar
ridge width is only 5-6
mm. Because of their
lower tensile 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 | 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 | | | platform connection geometry
between the proposed devices
and the predicate devices do not
pose any new or increased risks
as compared to the legally
marketed predicate devices
based on the performance
evaluation conducted on the
worst-case manufactured
dimensions which supports the
determination that the subject
devices are appropriate for their
intended use and do not render
the devices not substantially
equivalent. | |
| mm implants. | using ball abutments in | have to be taken by the | | | | |
| | Subject Device | Subject Device | Primary Predicate
Device | Reference Predicate
Device | Reference Predicate
Device | EQUIVALENCE DISCUSSION |
| | CONELOG®
PROGRESSIVE-LINE | CAMLOG®
PROGRESSIVE-LINE | CONELOG® SCREW-
LINE,
Promote®
K113779 | CAMLOG® SCREW-
LINE,
Promote® &
Promote® plus
K083496 | CAMLOG® ROOT-
LINE,
Promote® &
Promote® plus
K083496 | |
| | • The healing time for
diameter 3.3 mm
implants is at least 12
weeks.
CONELOG® Implants
with 7 mm length have
the following additional
specific indications:
These 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. | combination with Ø 3.3
mm implants.
• The healing time for
diameter 3.3 mm
implants is at least 12
weeks. | dental professional. | | | |
| Design | | | | | | |
| Implant Shape | Dental implant with a
cylindrical coronal
section and a tapered
apical section
(same as CAMLOG®
PROGRESSIVE-LINE) | Dental implant with a
cylindrical coronal
section and a tapered
apical section | implant shape with a
collar, a cylindrical
coronal section and a
tapered apical section
(same as CAMLOG®
SCREW-LINE) | implant shape with a
collar, a cylindrical
coronal section and a
tapered apical section | implant shape with
a collar, a short
cylindrical coronal
section and a longer
tapered section if
compared to
SCREW-LINE | CONELOG® PROGRESSIVE-
LINE same as Primary &
Reference Predicate;
CAMLOG® PROGRESSIVE-
LINE same as Primary &
Reference Predicate (minus
the collar) |
| Implant Body
Diameter | 3.3, 3.8, 4.3, 5.0mm | 3.3, 3.8, 4.3, 5.0mm | 3.3, 3.8, 4.3, 5.0mm | 3.3, 3.8, 4.3, 5.0,
6.0mm | 3.8, 4.3, 5.0, 6.0mm | Same as Primary Predicate;
within body diameter range
established by Reference
Predicate |
| Subject Device | Subject Device | Primary Predicate
Device | Reference Predicate
Device | Reference Predicate
Device | EQUIVALENCE DISCUSSION | |
| CONELOG®
PROGRESSIVE-LINE | CAMLOG®
PROGRESSIVE-LINE | CONELOG® SCREW-
LINE,
Promote®
K113779 | CAMLOG® SCREW-
LINE,
Promote® &
Promote® plus
K083496 | CAMLOG® ROOT-
LINE,
Promote® &
Promote® plus
K083496 | | |
| Implant Length | 7, 9, 11, 13, 16mm | 9, 11, 13, 16mm | 7, 9, 11, 13, 16mm | 9, 11, 13, 16mm | 9, 11, 13, 16mm | CONELOG® PROGRESSIVE-
LINE same as Primary
Predicate; CAMLOG®
PROGRESSIVE-LINE within
implant length range
established by Primary
Predicate (minus the 7mm
implant length) and same as
Reference Predicate |
| Outer thread | pitch 1.0mm | pitch 1.0mm | pitch 0.7mm | pitch 0.7mm | pitch 0.7mm | Substantially Equivalent
The subject devices have a
different thread pitch/design in
order to achieve good primary
stability in bone. The device
related risks associated with the
use of CAMLOG®/CONELOG®
PROGRESSIVE-LINE were
assessed and determined to be
substantially equivalent to the
predicate devices (i.e. FMEA).
Dynamic mechanical fatigue
testing results indicate
performance is suitable for the
intended use and are
substantially equivalent to the
predicate devices. |
| Surface | Promote® surface | Promote® surface | Promote® surface | Promote® surface | Promote® surface | Same for All
(i.e. Promote® / Promote®
plus) |
| Implant
Abutment
Connection | CONELOG®
conical connection with
a distal section having
3 cams to control
rotational position | CAMLOG®
tube-in-tube
connection, indexing
section having 3 cams
to control rotational
position | CONELOG®
conical connection with
a distal section having
3 cams to control
rotational position | CAMLOG®
tube-in-tube
connection, indexing
section having 3 cams
to control rotational
position | CAMLOG®
tube-in-tube
connection, indexing
section having 3 cams
to control rotational
position | CONELOG® PROGRESSIVE-
LINE same as Primary
Predicate; CAMLOG®
PROGRESSIVE-LINE same as
Reference Predicate |
| Implant Neck | no machined neck,
undercut in neck area | 0.4mm machined,
undercut in neck area | no machined neck,
undercut in neck area | either 1.4 or 0.4mm
machined, undercut in
neck area | either 2.0 or 0.4mm
machined, undercut in
neck area | CONELOG® PROGRESSIVE-
LINE same as Primary
Predicate; CAMLOG®
PROGRESSIVE-LINE same as
Reference Predicate |
| Subject Device | Subject Device | Primary Predicate
Device | Reference Predicate
Device | Reference Predicate
Device | | |
| | CONELOG®
PROGRESSIVE-LINE | CAMLOG®
PROGRESSIVE-LINE | CONELOG® SCREW-
LINE,
Promote®
K113779 | CAMLOG® SCREW-
LINE,
Promote® &
Promote® plus
K083496 | CAMLOG® ROOT-
LINE,
Promote® &
Promote® plus
K083496 | EQUIVALENCE DISCUSSION |
| Material and Manufacturing | | | | | | |
| Implant
Material | CPTi | CPTi | CPTi | CPTi | CPTi | Same for All |
| Manufacturing
process | Machined by Altatec
GmbH | Machined by Altatec
GmbH | Machined by Altatec
GmbH | Machined by Altatec
GmbH | Machined by Altatec
GmbH | Same for All |
| Packaging | sterile packed (implants
& cover screws) | sterile packed (implants
& cover screws) | sterile packed (implants
& cover screws) | sterile packed (implants
& cover screws) | sterile packed (implants
& cover screws) | Same for All |
| Sterilization | gamma sterilization | gamma sterilization | gamma sterilization | gamma sterilization | gamma sterilization | Same for All |
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