CAMLOG® and CONELOG® Abutments for Screw-retained Restorations (ASR) are intended to support occlusal screw- retained prosthetic restorations in the upper jaw and lower jaw in conjunction with CAMLOG® and CONELOG® Implants.

Device Description

Abutment for Screw-retained Restorations (ASR) is available with the Camlog or the Conelog implant/abutment interface. ASR Straight is provided in five platform diameters (3.3. 3.8. 4.3. 5.0 and 6.0 mm) and three gingival heights (0.5, 2.0 and 4.0 mm), for a total of 15 abutment options. ASR Angled is provided in four platform diameters (3.3, 3.8, 4.3, and 5.0 mm), four gingival heights (2.5, 3.5, 4.0 and 5.0 mm), and two angles (17° and 30°). Each of the angled designs is provided in a Type A option (anti-rotation cam alignment away from the abutment cone angle) or Type B option (anti-rotation cam alignment in the direction of the abutment cone angle), for a total of 32 abutment options. A healing cap, and a titanium cap for temporary or permanent restoration fabrication are available for all sizes. All ASR components are made from titanium alloy conforming to ASTM F136 Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401).

AI/ML Overview

This document describes the premarket notification (510(k)) for the CAMLOG® and CONELOG® Abutments for Screw-retained Restorations (ASR). This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving direct clinical effectiveness against specific acceptance criteria. Therefore, the information typically requested regarding acceptance criteria and a study proving those criteria are met is not directly applicable in the same way as for a novel device or a clinical trial.

However, based on the provided text, we can infer the equivalence criteria and the studies performed to demonstrate substantial equivalence, which serves a similar purpose in the 510(k) process.

Here's the breakdown of the information related to acceptance criteria and supporting studies, interpreted within the context of a 510(k) submission:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a 510(k) submission, the "acceptance criteria" are predominantly related to demonstrating substantial equivalence to predicate devices in terms of intended use, technological characteristics, and material. The "reported device performance" is the comparison made against the predicate devices.

Acceptance Criteria (Demonstration of Substantial Equivalence)	Reported Device Performance (Subject Device vs. Predicate)
Similar Indications for Use	Both subject device and predicate support occlusal screw-retained prosthetic restorations in conjunction with dental implants. The difference in language does not change the intended use.
Similar Design (Technological Characteristics)	Prosthesis Attachment: Both are screw-retained. Abutment Platform Diameter: Subject (3.3 - 6.0 mm) overlaps with Primary Predicate (3.5 - 4.6 mm) and Reference Predicates (3.3 - 6.0 mm). Abutment Angle: Subject (Straight to 30°) matches Primary Predicate (Straight to 30°) and Reference Predicates (Straight to 20°/30°). Availability of Straight and Angled Abutments: Both have straight and angled options (17° and 30°). Gingival Heights: Similar multiple gingival heights (e.g., subject: 0.5, 2.0, 4.0 mm, predicate: 1.0 - 4.0 mm). Indexing Orientations: Both include Type A and B indexing. Titanium Cap: Both subject and primary predicate have a titanium cap for temporary or permanent restorations.
Similar Materials	Abutment Material: Subject device uses Ti-6AL-4V ELI, while Primary Predicate uses Ti-6AL-7Nb. Reference Predicates also use Ti-6AL-4V ELI. The document suggests these are "similar materials."
Similar Sterilization Methods	Both subject and predicate devices are sterilized using similar methods.
Similar Packaging Materials	Both subject and predicate devices are packaged in similar materials.
Satisfactory Non-Clinical Performance (Specific Tests)	Sterilization Validation: ISO 11137-1, ISO 11137-2, ISO 17665-1, ISO 17665-2. Biocompatibility: ISO 10993-1. Mechanical Performance: Static and dynamic compression-bending testing according to ISO 14801 (Dentistry - Implants - Dynamic fatigue test for endosseous dental implants).

2. Sample Size Used for the Test Set and Data Provenance

For a 510(k) submission focused on substantial equivalence through non-clinical testing, there isn't a "test set" in the traditional sense of a clinical study with a patient cohort.

Non-Clinical Tests: The sample sizes for each non-clinical test (sterilization, biocompatibility, mechanical fatigue) would be determined by the specific ISO standards referenced (e.g., ISO 14801 for fatigue testing often specifies sample sizes for statistical significance). These details are not provided in the document.
Data Provenance: The data provenance is from non-clinical laboratory testing conducted by the manufacturer (Altatec GmbH). The country of origin for the data is Germany (manufacturer's location). The data is prospective in the sense that these tests were conducted specifically for this submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable as there was no clinical test set requiring expert ground truth establishment. The ground truth for the non-clinical tests is based on the specific requirements and methodologies outlined in the referenced ISO standards.

4. Adjudication Method for the Test Set

This information is not applicable as there was no clinical test set.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. The document explicitly states: "Clinical data were not submitted in this premarket notification."

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

This question is not applicable as the device is a physical dental abutment and not an AI algorithm.

7. The Type of Ground Truth Used

For the non-clinical tests, the "ground truth" is defined by the established international standards (ISO standards) referenced. For example:

For sterilization, the ground truth is achieving the specified Sterility Assurance Level (SAL) per ISO 11137.
For biocompatibility, the ground truth is demonstrating no unacceptable biological responses based on ISO 10993-1.
For dynamic fatigue, the ground truth is withstanding specified loads for a defined number of cycles, as per ISO 14801.

8. The Sample Size for the Training Set

This question is not applicable as the device is a physical dental abutment and not an AI algorithm.

9. How the Ground Truth for the Training Set was Established

This question is not applicable as the device is a physical dental abutment and not an AI algorithm.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

January 12, 2016

ALTATEC GmbH c/o Ms. Linda K. Schulz Regulatory Affairs PaxMed International, LLC 12264 El Camino Real, Suite 400 San Diego, California 92130

Re: K152509

Trade/Device Name: CAMLOG® and CONELOG® Abutments For Screw-retained Restorations (ASR) Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: December 10, 2015 Received: December 11, 2015

Dear Ms. Schulz:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Tina Kiang -S

for Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital. Respiratory. Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

Device Name

CAMLOG® and CONELOG® Abutments for Screw-retained Restorations (ASR)

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

|X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

Altatec GmbH CAMLOG® and CONELOG® Abutments for Screw-retained Restorations (ASR)

January 11, 2016

ADMINISTRATIVE INFORMATION

Manufacturer Name	Altatec GmbHMaybachstrasse 5D-71299 Wimsheim, Germany
	Telephone:	+49 7044 9445 0
	Fax:	+49 7044 9445 723
Official Contact	Colleen BoswellDirector of RA/QA Ortho Organizers, Inc.
Representative/Consultant	Linda K. Schulz, BSDH, RDHFloyd G. Larson, MS, MBAPaxMed International, LLC12264 El Camino Real, Suite 400San Diego, CA 92130
	Telephone:	+1 (858) 792-1235
	Fax:	+1 (858) 792-1236
	Email:	lschulz@paxmed.com flarson@paxmed.com

DEVICE NAME AND CLASSIFICATION

Trade/Proprietary Name	CAMLOG® and CONELOG® Abutments for Screw-retainedRestorations (ASR)
Common Name	Endosseous dental implant abutment
Classification Name	Endosseous dental implant abutment
Classification Regulations	21 CFR 872.3630, Class II
Product Code	NHA
Classification Panel	Dental Products Panel
Reviewing Branch	Dental Devices Branch

INTENDED USE

CAMLOG® and CONELOG® Abutments for Screw-retained Restorations (ASR) are intended to support occlusal screw-retained prosthetic restorations in the upper jaw and lower jaw in conjunction with CAMLOG® and CONELOG® Implants.

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PREDICATE INFORMATION

The primary predicate device is K133421.

Reference Predicates

K141871 - Straumann® Screw Retained Abutments K073553 - CAMLOG Implant System Abutments K083496 - CAMLOG Implant System Modified Implants and Abutments K113779 - CONELOG® Implant System

DEVICE DESCRIPTION

PERFORMANCE DATA

Non-clinical testing data submitted, referenced, or relied upon to demonstrate substantial equivalence included: sterilization validation according to : ISO 11137-1 Sterilization of health care products -- Radiation -- Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices and ISO 11137-2 Sterilization of health care products -- Radiation -- Part 2: Establishing the sterilization dose, ISO 17665-1 Sterilization of health care products – Moist heat – Part 1: Requirements for the development, validation, and routine control of a sterilization process for medical devices; ISO 17665-2 Sterilization of health care products – Moist heat – Part 2: Guidance on the application of ISO 17665-1; ISO 10993-1 Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process, and static and dynamic compression-bending testing according to ISO 14801 Dentistry - Implants - Dynamic fatigue test for endosseous dental implants.

Clinical data were not submitted in this premarket notification.

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EQUIVALENCE TO MARKETED DEVICE

The subject device is substantially equivalent in indications and design principles predicate devices shown above. Below are summary tables showing technical comparison between the subject device and the primary predicate devices.

	Indications for Use
Subject Device
Altatec GmbhCAMLOG® andCONELOG® Abutmentsfor Screw-retainedRestorations (ASR)	CAMLOG® and CONELOG® Abutments for Screw-retained Restorations (ASR)are intended to support occlusal screw-retained prosthetic restorations in the upperjaw and lower jaw in conjunction with CAMLOG® and CONELOG® Implants.
Primary Predicate Device
Straumann USA, LLCStraumann® Magellan™Abutment SystemK133421	The Straumann® Magellan™ abutments are indicated to be placed into Straumann®dental implants to provide support for prosthetic reconstructions such as crowns,bridges and bars.The final processed devices have the purpose of restoring chewing function.Magellan™ abutments are indicated for screw-retained restorations.

	SubjectDevice	PrimaryPredicate	Reference Predicate Devices
	Altatec Gmbh	StraumannUSA, LLC	StraumannUSA, LLC	AltatecGmbH	Altatec Gmbh
	CAMLOG®andCONELOG®Abutments forScrew-retainedRestorations(ASR)	Straumann®Magellan™AbutmentSystem	Straumann®ScrewRetainedAbutments	CAMLOGImplantSystemAbutments	CONELOG®ImplantSystem
		K133421	K141871	K073553	K113779
Design
ProsthesisAttachment	Screw-retained	Screw-retained	Screw-retained	Screw-retained	Screw-retained
AbutmentPlatformDiameter,mm	3.3 - 6.0	3.5 - 4.6	4.6	3.3 - 6.0	3.3 - 5.0
AbutmentAngle	Straight to 30°	Straight to 30°	Straight to30°	Straight to20°	Straight to20°
Material
Abutment	Ti-6AL-4VELI	Ti-6AL-7Nb	Ti-6AL-7Nb	Ti-6AL-4VELI	Ti-6AL-4VELI

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Abutment for Screw-retained Restorations (ASR) is substantially equivalent to the predicate devices in K133421 and K141871. K133421 is the primary predicate having straight and angled abutments (17° and 30°), multiple gingival heights (1.0 - 4.0 mm) and Type A and B indexing orientations. Straumann® Screw Retained Abutments K141871 adds angled abutments for the NC diameter implant. Both ASR and Straumann Screw-retained Abutment have a titanium cap designed for temporary or permanent restorations. The subject device and primary predicate have slightly different Indications for Use language. However, the difference in language does not change the intended use of abutments. Both abutments are being used in conjunction with dental implants for the purpose of supporting screw-retained dental prostheses.

CONCLUSIONS

The subject device and the predicate devices have intended use, have similar technological characteristics, and are made of similar materials. The subject device and predicate devices encompass the same range of physical dimensions, including length, diameter, height, and angle of the abutment. The subject and predicate devices are packaged in similar materials and sterilized using similar methods.

The data included in this submission demonstrate substantial equivalence to the predicate devices listed above.

Regulation Number and Section

§ 872.3630 Endosseous dental implant abutment.

(a)
Identification. An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)

Indications for Use

Device Name

Indications for Use (Describe)

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510(k) Summary

Altatec GmbH CAMLOG® and CONELOG® Abutments for Screw-retained Restorations (ASR)

ADMINISTRATIVE INFORMATION

DEVICE NAME AND CLASSIFICATION

INTENDED USE

PREDICATE INFORMATION

DEVICE DESCRIPTION

PERFORMANCE DATA

EQUIVALENCE TO MARKETED DEVICE

CONCLUSIONS

§ 872.3630 Endosseous dental implant abutment.

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