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.

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.

AI/ML Overview

The provided text is a 510(k) Premarket Notification from the FDA for dental implants. It does not describe an AI medical device or a study that uses a test set, expert ground truth, or addresses human-in-the-loop performance. Therefore, I cannot generate the requested information about acceptance criteria and study details for an AI medical device.

The document focuses on demonstrating substantial equivalence of the "Altatec GmbH CAMLOG®/CONELOG® PROGRESSIVE-LINE Implants" to existing legally marketed predicate devices. The "Summary of Testing" section (page 7-8) details mechanical fatigue testing, sterilization validation, endotoxin testing, and accelerated aging for shelf-life, which are relevant to the physical and biological properties of the dental implants, not AI performance.

To provide the requested information, I would need a document describing an AI medical device and its performance study.

Summary

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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.

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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

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Indications for Use

510(k) Number (if known) K193401

Device Name

Altatec GmbH CAMLOG® / CONELOG® PROGRESSIVE-LINE Implants

Indications for Use (Describe)

· 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:

· 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.

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510(k) Summarv 21 CFR 807.92

Submitter's Name & Address

Manufacturer:	Altatec GmbHMaybachstrasse 5Wimsheim, Germany D-71299Phone +49 7044 9445 0Fax +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 CenterBirmingham, AL 35244Phone (205) 967-7880Fax (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

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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.

Indications for Use

· single-tooth gaps,
· partially edentulous jaws with several missing teeth or
· edentulous jaws.

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CAMLOG®/CONELOG® PROGRESSIVE-LINE Implants with a diameter of 3.3 mm have the following additional specific indications:

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:

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.

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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

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& 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.

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Table 2: Summary Table of Substantial Equivalence

	Subject Device	Subject Device	Primary PredicateDevice	Reference PredicateDevice	Reference PredicateDevice
	CONELOG®PROGRESSIVE-LINE	CAMLOG®PROGRESSIVE-LINE	CONELOG® SCREW-LINE,Promote®K113779	CAMLOG® SCREW-LINE,Promote® &Promote® plusK083496	CAMLOG® ROOT-LINE,Promote® &Promote® plusK083496	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
ClinicalConditionWhen Used	partial or fulledentulism	partial or fulledentulism	partial or fulledentulism	partial or fulledentulism	partial or fulledentulism	Same for All
Site of Body	both jaws(maxilla and/ormandible)	both jaws(maxilla and/ormandible)	both jaws(maxilla and/ormandible)	both jaws(maxilla and/ormandible)	both jaws(maxilla and/ormandible)	Same for All
Intended Use	functional and / oresthetical oralrehabilitation ofpartially or fullyedentulous patients	functional and / oresthetical oralrehabilitation ofpartially or fullyedentulous patients	functional and / oresthetical oralrehabilitation ofpartially or fullyedentulous patients	functional and / oresthetical oralrehabilitation ofpartially or fullyedentulous patients	functional and / oresthetical oralrehabilitation ofpartially or fullyedentulous patients	Same for All
Indications	CONELOG®PROGRESSIVE-LINEimplants are indicatedfor the restoration ofedentulous and partiallyedentulous jaws withprosthetic restorations	CAMLOG®PROGRESSIVE-LINEimplants are indicatedfor the restoration ofedentulous andpartially edentulousjaws with prosthetic	CONELOG® ImplantSystem Implants areintended for immediateor delayed placementin the bone of themaxillary or mandibulararch. CONELOG®	CAMLOG® ImplantSystem implants areintended for immediateor delayed placementin the bone of themaxillary or mandibulararch. CAMLOG®	CAMLOG® ImplantSystem implants areintended forimmediate or delayedplacement in the boneof the maxillary ormandibular arch.	Substantially EquivalentAlthough the wording in theIndications for Use are notidentical between the subjectdevices and the predicatedevices, the content is
Subject Device	Subject Device	Primary PredicateDevice	Reference PredicateDevice	Reference PredicateDevice	EQUIVALENCE DISCUSSION
CONELOG®PROGRESSIVE-LINE	CAMLOG®PROGRESSIVE-LINE	CONELOG® SCREW-LINE,Promote®K113779	CAMLOG® SCREW-LINE,Promote® &Promote® plusK083496	CAMLOG® ROOT-LINE,Promote® &Promote® plusK083496
such as implant-supported singlecrowns, bridges and fulldentures. Specificallyfor:• single-tooth gaps,• partially edentulousjaws with severalmissing teeth or• edentulous jaws.CONELOG®PROGRESSIVE-LINEImplants are suitable fororal endosseousimplantation in themaxillary and/ormandibular bone andare intended forimmediate or delayedimplantation. They areindicated fortransgingival healing(one-stage, usinghealing caps orabutments) orsubgingival healing(two-stage, using coverscrews). If single-phasehealing is intended, theimplants can be loadedimmediately if theprimary stabilityachieved is adequatefor functional loading. Inconjunction with thecorrespondingabutments, the implantscan be used for screw-retained or cementedrestorations such assingle crowns, bridgesand full dentures.	restorations such asimplant-supportedsingle crowns, bridgesand full dentures.Specifically for:• single-tooth gaps,• partially edentulousjaws with severalmissing teeth or• edentulous jaws.CAMLOG®PROGRESSIVE-LINEImplants are suitablefor oral endosseousimplantation in themaxillary and/ormandibular bone andare intended forimmediate or delayedimplantation. They areindicated fortransgingival healing(one-stage, usinghealing caps orabutments) orsubgingival healing(two-stage, using coverscrews). If single-phase healing isintended, the implantscan be loadedimmediately if theprimary stabilityachieved is adequatefor functional loading.In conjunction with thecorrespondingabutments, theimplants can be usedfor screw-retained orcemented restorationssuch as single crowns,	Implant SystemAbutments areintended for use assupport for crowns,bridges oroverdentures. When aone-stage surgicalapproach is applied,the implant may beimmediately loadedwhen good primarystability is achievedand the functional loadis appropriate.CONELOG® Implantswith 3.3 mm diameterhave the followingadditional specificindications:These are analternative in caseswhere the alveolarridge width is only 5 - 6mm. Because of theirlower mechanicalstrength compared withlarger diameterimplants, they shouldonly be used under thefollowing conditions:• As single implants,they should be usedonly to replacemandibular incisorsand/or maxillary lateralincisors.• An edentulous archcan only be restoredwith a bar retainedsuperstructure with atleast four implants of3.3 mm diameterwithout distal	Implant SystemAbutments areintended for use assupport for crowns,bridges oroverdentures. When aone-stage surgicalapproach is applied,the implant may beimmediately loadedwhen good primarystability is achievedand the functional loadis appropriate.	CAMLOG® ImplantSystem Abutments areintended for use assupport for crowns,bridges oroverdentures. When aone-stage surgicalapproach is applied,the implant may beimmediately loadedwhen good primarystability is achievedand the functional loadis appropriate.	substantially equivalent for thesubject devices and the primarypredicate device (K113779).The Indications for Use of thereference predicate devices(K083496) and the subjectdevices share the generalindications that arecorresponding with that of boththe subject devices and theprimary predicate device(K113779).In both cases the subject andpredicate devices are intendedfor surgical placement in themaxillary and/or mandibularbone for the purpose of attachinga dental prosthesis. The totalityof the preceding description andthe mechanism of action astested indicates that there is nosubstantial difference betweenthe subject devices and theprimary predicate device(K113779) with respect to eitherindications for use ortechnological characteristics.The proposed devices do notpose any new or increased risksas compared to the legallymarketed predicate devices.Both the subject devices andpredicate devices include sharedfeatures, as provided in thisSummary Table of SubstantialEquivalence, which therebydemonstrates substantialequivalence in their respectivedesigns. Any specificdifferences related to implantshape, body diameter, external
	bridges and full	without distal			thread design and prosthetic
Subject Device	Subject Device	Primary PredicateDevice	Reference PredicateDevice	Reference PredicateDevice	EQUIVALENCE DISCUSSION
CONELOG®PROGRESSIVE-LINE	CAMLOG®PROGRESSIVE-LINE	CONELOG® SCREW-LINE,Promote®K113779	CAMLOG® SCREW-LINE,Promote® &Promote® plusK083496	CAMLOG® ROOT-LINE,Promote® &Promote® plusK083496
Implants with adiameter of 3.3 mm areindicated as analternative in caseswhere the alveolar ridgewidth is only 5-6 mm.Because of their lowertensile strengthcompared with largerdiameter implants, theyshould only be usedunder the followingconditions:• As single implants,they should be usedonly to replacemandibular incisorsand/or maxillary lateralincisors.• An edentulous archcan only be restoredwith a bar retainedsuperstructure with atleast four implants of3.3 mm diameterwithout distalextensions.• Implants of Ø 3.3 mmare suitable for apartially edentulousarch when combinedwith implants of largerdiameter for splintedsuperstructures.However, the limitedstrength of the implantswith Ø 3.3 mm must betaken into account.• Avoid excessivemechanical stressing ofthe implants when usingball abutments incombination with Ø 3.3mm implants.	dentures.Implants with adiameter of 3.3 mm areindicated as analternative in caseswhere the alveolarridge width is only 5-6mm. Because of theirlower tensile strengthcompared with largerdiameter implants, theyshould only be usedunder the followingconditions:• As single implants,they should be usedonly to replacemandibular incisorsand/or maxillary lateralincisors.• An edentulous archcan only be restoredwith a bar retainedsuperstructure with atleast four implants of3.3 mm diameterwithout distalextensions.• Implants of Ø 3.3 mmare suitable for apartially edentulousarch when combinedwith implants of largerdiameter for splintedsuperstructures.However, the limitedstrength of the implantswith Ø 3.3 mm must betaken into account.• Avoid excessivemechanical stressing ofthe implants when	extensions.• Implants of Ø 3.3mm are suitable for apartially edentulousarch when combinedwith implants of largerdiameter for splintedsuperstructures.However, the limitedstrength of theimplants with Ø 3.3mm must be taken intoaccount.• Avoid excessivemechanical stressingof the implants whenusing ball abutments incombination with Ø 3.3mm implants.• The healing time forØ 3.3 mm implants isat least 12 weeks.CONELOG® Implantswith 7 mm length havethe following additionalspecific indications:CONELOG® SCREW-LINE Implants shouldonly be used whenthere is not enoughspace for a longerimplant. Delayedloading in single toothreplacement isindicated with theseimplants. If the ratio ofcrown length to implantlength is unfavorablethe biomechanical riskfactors have to beconsidered andappropriate measures			platform connection geometrybetween the proposed devicesand the predicate devices do notpose any new or increased risksas compared to the legallymarketed predicate devicesbased on the performanceevaluation conducted on theworst-case manufactureddimensions which supports thedetermination that the subjectdevices are appropriate for theirintended use and do not renderthe devices not substantiallyequivalent.
mm implants.	using ball abutments in	have to be taken by the
	Subject Device	Subject Device	Primary PredicateDevice	Reference PredicateDevice	Reference PredicateDevice	EQUIVALENCE DISCUSSION
	CONELOG®PROGRESSIVE-LINE	CAMLOG®PROGRESSIVE-LINE	CONELOG® SCREW-LINE,Promote®K113779	CAMLOG® SCREW-LINE,Promote® &Promote® plusK083496	CAMLOG® ROOT-LINE,Promote® &Promote® plusK083496
	• The healing time fordiameter 3.3 mmimplants is at least 12weeks.CONELOG® Implantswith 7 mm length havethe following additionalspecific indications:These Implants shouldonly be used whenthere is not enoughspace for a longerimplant. Delayedloading in single toothreplacement isindicated with theseimplants. If the ratio ofcrown length to implantlength is unfavorablethe biomechanical riskfactors have to beconsidered andappropriate measureshave to be taken by thedental professional.	combination with Ø 3.3mm implants.• The healing time fordiameter 3.3 mmimplants is at least 12weeks.	dental professional.
Design
Implant Shape	Dental implant with acylindrical coronalsection and a taperedapical section(same as CAMLOG®PROGRESSIVE-LINE)	Dental implant with acylindrical coronalsection and a taperedapical section	implant shape with acollar, a cylindricalcoronal section and atapered apical section(same as CAMLOG®SCREW-LINE)	implant shape with acollar, a cylindricalcoronal section and atapered apical section	implant shape witha collar, a shortcylindrical coronalsection and a longertapered section ifcompared toSCREW-LINE	CONELOG® PROGRESSIVE-LINE same as Primary &Reference Predicate;CAMLOG® PROGRESSIVE-LINE same as Primary &Reference Predicate (minusthe collar)
Implant BodyDiameter	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 rangeestablished by ReferencePredicate
Subject Device	Subject Device	Primary PredicateDevice	Reference PredicateDevice	Reference PredicateDevice	EQUIVALENCE DISCUSSION
CONELOG®PROGRESSIVE-LINE	CAMLOG®PROGRESSIVE-LINE	CONELOG® SCREW-LINE,Promote®K113779	CAMLOG® SCREW-LINE,Promote® &Promote® plusK083496	CAMLOG® ROOT-LINE,Promote® &Promote® plusK083496
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 PrimaryPredicate; CAMLOG®PROGRESSIVE-LINE withinimplant length rangeestablished by PrimaryPredicate (minus the 7mmimplant length) and same asReference Predicate
Outer thread	pitch 1.0mm	pitch 1.0mm	pitch 0.7mm	pitch 0.7mm	pitch 0.7mm	Substantially EquivalentThe subject devices have adifferent thread pitch/design inorder to achieve good primarystability in bone. The devicerelated risks associated with theuse of CAMLOG®/CONELOG®PROGRESSIVE-LINE wereassessed and determined to besubstantially equivalent to thepredicate devices (i.e. FMEA).Dynamic mechanical fatiguetesting results indicateperformance is suitable for theintended use and aresubstantially equivalent to thepredicate devices.
Surface	Promote® surface	Promote® surface	Promote® surface	Promote® surface	Promote® surface	Same for All(i.e. Promote® / Promote®plus)
ImplantAbutmentConnection	CONELOG®conical connection witha distal section having3 cams to controlrotational position	CAMLOG®tube-in-tubeconnection, indexingsection having 3 camsto control rotationalposition	CONELOG®conical connection witha distal section having3 cams to controlrotational position	CAMLOG®tube-in-tubeconnection, indexingsection having 3 camsto control rotationalposition	CAMLOG®tube-in-tubeconnection, indexingsection having 3 camsto control rotationalposition	CONELOG® PROGRESSIVE-LINE same as PrimaryPredicate; CAMLOG®PROGRESSIVE-LINE same asReference 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 0.4mmmachined, undercut inneck area	either 2.0 or 0.4mmmachined, undercut inneck area	CONELOG® PROGRESSIVE-LINE same as PrimaryPredicate; CAMLOG®PROGRESSIVE-LINE same asReference Predicate
Subject Device	Subject Device	Primary PredicateDevice	Reference PredicateDevice	Reference PredicateDevice
	CONELOG®PROGRESSIVE-LINE	CAMLOG®PROGRESSIVE-LINE	CONELOG® SCREW-LINE,Promote®K113779	CAMLOG® SCREW-LINE,Promote® &Promote® plusK083496	CAMLOG® ROOT-LINE,Promote® &Promote® plusK083496	EQUIVALENCE DISCUSSION
Material and Manufacturing
ImplantMaterial	CPTi	CPTi	CPTi	CPTi	CPTi	Same for All
Manufacturingprocess	Machined by AltatecGmbH	Machined by AltatecGmbH	Machined by AltatecGmbH	Machined by AltatecGmbH	Machined by AltatecGmbH	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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Regulation Number and Section

§ 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.