CAM Titanium Blanks are intended for the fabrication of abutments and healing caps on CAMLOG® SCREW-LINE and CAMLOG® ROOT-LINE implants in the maxilla and mandible for the purpose of supporting single or multiple tooth prostheses of a partially or fully edentulous patient. Digitally designed abutments fabricated with CAD/CAM techniques for use with CAMLOG® CAM Titanium Blanks are intended to be sent to a CAMLOG validated milling center for manufacture.

CAM Titanium Blanks are intended for the fabrication of abutments and healing caps on CONELOG® SCREW-LINE implants in the maxilla and mandible for the purpose of supporting single ooth prostheses of a partially or fully edentulous patient. Digitally designed abutments fabricated with CAD/CAM techniques for use with CONELOG® CAM Titanium Blanks are intended to be sent to a CAMLOG validated milling center for manufacture.

CAM Titanium Blanks are intended for the fabrication of abutments and healing caps/gingiva former on iSy® implants in the maxilla and mandible for the purpose of supporting single or multiple tooth prostheses of a partially or fully edentulous patient. Digitally designed abutments fabricated with CAD/CAM techniques for use with iSy CAM Titanium Blanks are intended to be sent to a CAMLOG validated milling center for manufacture.

Device Description

CAM Titanium Blanks are abutments with a prefabricated, precision interface (implant/abutment connection) and a screw channel suitable for the respective implant system. CAM Titanium Blanks are to be used by a CAMLOG validated milling center with CAD/CAM technology to fabricate a final finished customized abutment made of titanium alloy. Each patient-specific abutment is individually prescribed by the clinician as a temporary, permanent, single, or multi-unit abutment. Computer-aided manufacturing (CAM) techniques are used to process the cylinder portion above the implant connection into an individual abutment or healing cap/gingiva former design. The healing cap/gingival former is temporary and used during healing. Permanent abutments have straight and angled designs that can be used for crowns, bridges or overdentures.

CAM Titanium Blanks are available for CAMLOG SCREW-LINE and ROOT-LINE implants fitting five implant diameters (3.3. 3.8. 4.3. 5.0. 6.0 mm), for CONELOG SCREW-LINE implants fitting four implant diameters (3.3. 3.8, 4.3, 5.0 mm), and for the iSy implants with one connection fitting three implant diameters (3.8, 4.4, 5.0 mm).

AI/ML Overview

This document is a 510(k) summary for the "CAM Titanium Blanks" dental device, which is related to endosseous dental implant abutments. It primarily focuses on demonstrating substantial equivalence to predicate devices based on design, materials, and intended use, rather than presenting a performance study with specific acceptance criteria and detailed quantitative results.

Therefore, much of the requested information regarding acceptance criteria and performance study specifics for an AI/ML device (like sample size for test/training sets, ground truth establishment, expert qualifications, MRMC studies, standalone performance) is not applicable or present in this regulatory submission.

However, I can extract the information that is available:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not provide specific quantitative acceptance criteria or corresponding reported device performance values in the way one might see for an AI/ML diagnostic or predictive device (e.g., sensitivity, specificity, AUC thresholds). Instead, the "acceptance criteria" are implied by demonstrating substantial equivalence through:

Non-clinical testing: This includes sterilization validation, biological evaluation, and mechanical testing. The acceptance here is successful completion according to the referenced standards.
Comparison of Indications for Use: The claim is that the indications are "substantially equivalent."
Comparison of Technological Characteristics: The claim is that the characteristics are "similar" or "substantially equivalent."

Acceptance Criteria (Implied from Substantial Equivalence Determination)	Reported Device Performance (as demonstrated by comparison/testing)
Sterilization validated per ISO 17665-1 and ISO 17665-2	Sterilization validated (by reference to standards)
Biological evaluation per ISO 10993-1	Biological evaluation complete (by reference to K083496, K113779, K133991)
MR testing per ASTM F2052, F2213, F2182, F2119	MR testing complete (by reference to standards)
Static and dynamic compression-bending testing per ISO 14801	Static and dynamic compression-bending testing complete (by reference to standard)
Indications for Use are substantially equivalent to predicates	Indications for Use are "substantially equivalent"
Technological Characteristics are similar to predicates	Design, material (Ti-6Al-4V ELI), and intended use are "substantially equivalent" or "similar" to predicates. Similar range of physical dimensions (diameter 3.3-6.0 mm, angle up to 30°).

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This document is for a mechanical dental device (titanium blanks for abutments), not an AI/ML-driven device that typically uses test sets of data.
The "test set" here refers to the actual physical devices subjected to non-clinical tests. The sample sizes for these specific non-clinical tests (sterilization, biological, MR, mechanical) are not explicitly stated in this summary, but would be defined by the relevant ISO/ASTM standards referenced.
Data provenance (country of origin, retrospective/prospective) is not applicable in the context of this summary for a mechanical device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable as this is a mechanical device, not an AI/ML device relying on expert-labeled ground truth data. The "ground truth" for mechanical properties would be derived from standard test methods and measurements, not expert consensus on interpretations.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This is a mechanical device.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI/ML diagnostic tools that assist human readers, which this device is not.

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

Not applicable. This is a mechanical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for demonstrating the safety and effectiveness of this mechanical dental device is based on established engineering standards and material properties testing. For example, the "ground truth" for mechanical strength is whether the device withstands specified forces according to ISO 14801. The "ground truth" for biocompatibility is conformance to ISO 10993-1.

8. The sample size for the training set

Not applicable. This is a mechanical device, not an AI/ML device trained on data.

9. How the ground truth for the training set was established

Not applicable.

Summary

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of a human figure embracing a bird, which is a symbol of care and protection.

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

September 14, 2016

Altatec Gmbh % Linda Schulz Regulatory Affairs PaxMed International, LLC 12264 El Camino Real, Suite 400 San Diego, California 92130

Re: K160784

Trade/Device Name: CAM Titanium Blanks Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: August 17, 2016 Received: August 18, 2016

Dear Linda 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.

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

{1}------------------------------------------------

the quality systems (OS) 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,

Michael J. Ryan -S

for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known)

K160784

Device Name

CAM Titanium Blanks

Indications for Use (Describe)

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

X Prescription Use (Part 21 CFR 801 Subpart D)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

510(k) Summary Altatec GmbH CAM Titanium Blanks

September 12, 2016

ADMINISTRATIVE INFORMATION

Manufacturer Name	Altatec GmbHMaybachstrasse 5D-71299 Wimsheim, Germany
	Telephone:	+49 7044 9445 0
	Fax:	+49 7044-9445 723
Official Contact	Colleen Boswell
	Director of RA/QA, Henry Schein
Representative/Consultant	Linda K. Schulz, BSDH, RDH
	Floyd G. Larson, MS, MBA
	PaxMed International, LLC
	12264 El Camino Real, Suite 400
	San Diego, CA 92130
	Telephone:	+1 (858) 792-1235
	Fax:	+1 (858) 792-1236
	Email:	lschulz@paxmed.com
		flarson@paxmed.com

DEVICE NAME AND CLASSIFICATION

Trade/Proprietary Name	CAM Titanium Blanks
Common Name	Dental Implant Abutment
Classification Name	Endosseous dental implant abutment
Classification RegulationsProduct Code	21 CFR 872.3630, Class IINHA
Classification Panel:Reviewing Branch:	Dental Products PanelDental Devices Branch

PREDICATE DEVICE INFORMATION

Primary Predicate K150203, Medentika CAD/CAM Abutments, Medentika GmbH

Reference Predicates K092341, Low Profile Abutment, Biomet 3i K083496, CAMLOG® Implant System, Altatec GmbH K113779, CONELOG® Implant System. Altatec GmbH K133991, iSy® Implant System, Altatec GmbH

{4}------------------------------------------------

INDICATIONS FOR USE

CAM Titanium Blanks are intended for the fabrication of abutments and healing caps on CONELOG® SCREW-LINE implants in the maxilla and mandible for the purpose of supporting single or multiple tooth prostheses of a partially or fully edentulous patient. Digitally designed abutments fabricated with CAD/CAM techniques for use with CONELOG® CAM Titanium Blanks are intended to be sent to a CAMLOG validated milling center for manufacture.

CAM Titanium Blanks are intended for the fabrication of abutments and healing caps/gingiva former on iSy implants in the maxilla and mandible for the purpose of supporting single or multiple tooth prostheses of a partially or fully edentulous patient. Digitally designed abutments fabricated with CAD/CAM techniques for use with iSy CAM Titanium Blanks are intended to be sent to a CAMLOG validated milling center for manufacture.

DEVICE DESCRIPTION

PERFORMANCE DATA

Non-clinical testing data submitted, referenced, or relied upon to demonstrate substantial equivalence included: sterilization validation according to ISO 17665-1 and ISO 17665-2; biological evaluation according to ISO 10993-1 by reference to K083496. K113779. and K133991; MR testing according to ASTM F2052. ASTM F2213, ASTM F2182, and ASTM F2119; and static and dynamic compression-bending testing according to ISO 14801.

No clinical data were included in this submission.

EQUIVALENCE TO MARKETED DEVICE

The subject device is substantially equivalent in indications and design principles to the predicate devices shown above. Below are summary tables comparing the Indications for Use and the technological characteristics of the subject device and the predicate devices.

{5}------------------------------------------------

Comparison of Indications for Use Statements

	Indications for Use
Subject DeviceAltatec GmbHCAM Titanium BlanksK160784	CAM Titanium Blanks are intended for the fabrication of abutments and healing caps on CAMLOG® SCREW LINE and CAMLOG® ROOT-LINEimplants in the maxilla and mandible for the purpose of supporting single or multiple tooth prostheses of a partially or fully edentulous patient. Digitallydesigned abutments fabricated with CAD/CAM techniques for use with CAM Titanium Blanks are intended to be sent to a CAMLOG validated millingcenter for manufacture.CAM Titanium Blanks are intended for the fabrication of abutments and healing caps on CONELOG® SCREW-LINE implants in the maxilla andmandible for the purpose of supporting single or multiple tooth prostheses of a partially or fully edentulous patient. Digitally designed abutmentsfabricated with CAD/CAM techniques for use with CAM Titanium Blanks are intended to be sent to a CAMLOG validated milling center formanufacture.CAM Titanium Blanks are intended for the fabrication of abutments and healing caps/gingiva former on iSy® implants in the maxilla and mandible for thepurpose of supporting single or multiple tooth prostheses of a partially or fully edentulous patient. Digitally designed abutments fabricated withCAD/CAM techniques for use with CAM Titanium Blanks are intended to be sent to a CAMLOG validated milling center for manufacture.
Predicate Devices
Primary PredicateDevice						Medentika Preface CAD/CAM Abutments are intended for use with dental implants as a support for single or multiple tooth prostheses in the maxilla ormandible of a partially or fully edentulous patient.
Medentika GmbHMedentika CAD/CAMAbutmentsK150203		Implant System Compatibility	Series	Implant Diameter (mm)	Platform Diameter (mm)
		Nobel Biocare Replace™ Select	E	3.5, 4.3, 5.0, 6.0	3.5, 4.3, 5.0, 6.0
		Nobel Biocare NobelActive™	F	3.0, 3.5, 4.3, 5.0	3.0, 3.5, 3.9 (4.3), 3.9 (5.0)
		Biomet 3i Osseotite® Certain®	H	3.25, 4.0, 5.0	3.4, 4.1, 5.0
		Biomet 3i Osseotite®	I	3.25, 3.75, 4.0, 5.0	3.4, 4.1, 5.0
		Nobel Biocare Brånemark	K	3.3, 3.75, 4.0, 5.0	3.5, 4.1, 4.1, 5.1
		Straumann Bone Level	L	3.3, 4.1, 4.8	3.3, 4.1, 4.8
		Straumann Standard	N	3.3, 4.1, 4.8	3.5(NNC), 4.8, 6.5
		Zimmer Tapered Screw-vent®	R	3.3, 3.7, 4.1, 4.7, 6.0	3.5, 4.5, 5.7
		Astra Tech OsseoSpeed™	S	3.0, 3.5, 4.0, 4.5, 5.0	3.0, 3.5, 4.0, 4.5, 5.0
		Dentsply Friadent® Frialit/XiVE®	T	3.4, 3.8, 4.5, 5.5	3.4, 3.8, 4.5, 5.5
	Medentika PreFace is intended for use with the Straumann® CARES® System. All digitally designed abutments for use with Medentika CAD/CAMAbutments are intended to be manufactured at a Straumann® CARES® validated milling center.
Reference Predicate Devices
Biomet 3iLow Profile AbutmentK092341	Biomet 3i Low Profile Abutments are intended for use as accessories to endosseous dental implants to support a prosthetic device in a partially orcompletely edentulous patient. A dental abutment is intended for use to support single and multiple tooth prosthesis, in the mandible or maxilla. Theprosthesis is screw retained to the abutment.
Altatec GmbHCAMLOG ImplantSystem ModifiedImplants andAbutmentsK083496	Camlog Implant System implants are intended for immediate or delayed placement in the bone of the maxillary or mandibular arch. Camlog ImplantSystem Abutments are intended for use as support for crowns, bridges or overdentures. When a one-stage surgical approach is applied, the implant may beimmediately loaded when good primary stability is achieved and the functional load is appropriate.
Altatec GmbHConelog® ImplantSystemK113779	Implant Indications for UseCONELOG® Implant System Implants are intended for immediate or delayed placement in the bone of the maxillary or mandibular arch. CONELOG®Implant System Abutments are intended for use as support for crowns, bridges or overdentures. When a one-stage surgical approach is applied, the implantmay 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 largerdiameter implants, they should only be used under the following conditions:* As single implants, they should be used only to replace mandibular incisors and/or maxillary lateral incisors.* An edentulous arch can only be restored with a bar retained superstructure with at least four implants. of 3.3 mm diameter without distal extensions.* Implants of Ø 3.3 mm are suitable for a partially edentulous arch when combined with implants of larger diameter for splinted superstructures. However,the limited strength of the implants with Ø 3.3 mm must be taken into account.* Avoid excessive mechanical stressing of the implants when using ball abutments in combination with Ø 3.3 mm implants.* The healing time for Ø 3.3 mm implants is at least 12 weeks.CONELOG® Implants with 7 mm length have the following additional specific indications:CONELOG® SCREW-LINE Implants should only be used when there is not enough space for a longer implant. Delayed loading in single toothreplacement is indicated with these implants. If the ratio of crown length to implant length is unfavorable the biomechanical risk factors have to beconsidered and appropriate measures have to be taken by the dental professional.Abutment Indications for UseCONELOG® Abutments are intended to be used to fabricate prosthetic restorations in conjunction with CONELOG implants to support prostheses in themaxillary and/or mandibular arch.Vario SR Indications for UseCONELOG® Vario SR components for crown and bridge restorations:Occlusal screw-retained crown, bridge and bar constructions on CONELOG® implants in the anterior and posterior region of the maxilla and mandibleCONELOG® Vario SR components for bar restorations:Anchorage of implant-supported ful dentures for the edentulous maxilla in conjunction with 4 or more CONELOG® implants and in the edentulousmandible in conjunction with 2 or 4 or more CONELOG® implants.
Altatec GmbHiSy Implant SystemK133991	iSy® Implant System implants are intended for immediate or delayed placement in the bone of the maxillary or mandibular arch. iSy® Implant SystemAbutments are intended for use as support for crowns, bridges or overdentures. When a one-stage surgical approach is applied, the implant may beimmediately loaded when good primary stability is achieved and the functional load is appropriate.

{6}------------------------------------------------

	Subject Device	Primary Predicate	Reference Predicates
	Altatec GmbHCAM Titanium BlanksK160784	Medentika GmbHMedentika CAD/CAMAbutmentsK150203	Biomet 3iLow Profile AbutmentK092341	Altatec GmbHCAMLOG Implant SystemK083496	Altatec GmbHConelog Implant SystemK113779	Altatec GmbHiSy Implant SystemK133991
Prosthesis Attachment	Cement-retained	Cement-retained	Screw-retained	Screw-retainedCement-retained	Screw-retainedCement-retained	Screw-retainedCement-retained
Restoration type	Single orMulti-unit	Single orMulti-unit	Single orMulti-unit	Single orMulti-unit	Single orMulti-unit	Single orMulti-unit
Corresponding ImplantPlatformDiameter (mm)	3.3 - 6.0	3.0 - 7.0	3.4 - 5.0	3.3 - 6.0	3.3 - 5.0	3.8 - 5.0
Abutment Angle	Straight, up to 30°	Straight, up to 30°	Straight, up to 30°	Straight, up to 20°	Straight, up to 20°	Straight, up to 20°
Abutment materials	Ti-6Al-4V ELI	Ti-6Al-4V ELI	Ti-6Al-4V ELI	Ti-6Al-4V ELI, Zirconia	Ti-6Al-4V ELI	Ti-6Al-4V ELI
Screw material	Ti-6Al-4V ELI	Ti-6Al-4V ELI	Ti-6Al-4V ELI	Ti-6Al-4V ELI	Ti-6Al-4V ELI	Ti-6Al-4V ELI

Comparison of Technological Characteristics

The subject device and the primary predicate K150203 have similar Indications for Use statements. The slight differences in language and details specific to each device do not change the intended use to support prosthetic restorations on endosseous dental implants. The reference predicate devices are included to support substantial equivalence of implant compatibility (K083496, K113779, K133991) and for abutment parameters (K092341), and also do not alter the intended use of the subject device.

CAM Titanium Blanks are available for three CAMLOG implant lines, CAMLOG®, CONELOG®, and iSy °. The implant/abutment interface connections are identical to the previously cleared CAMLOG® (K083496), CONELOG® (K113779), and iSy® (K133991) connections.

The design, material and intended use of CAM Titanium Blanks are substantially equivalent to that of the primary predicate Medentika CAD/CAM Abutments (K150203). The CAM Titanium Blanks and Medentika Preface both have a precision machined interface for the implant/abutment connection and are suited for CAD/CAM fabrication of customized endosseous dental implant abutments for single or multi-unit restorations. CAM Titanium Blanks and Medentika Preface abutments are indicated for a single or multi-unit restoration with an abutment angulation up to 30°. CAM Titanium Blank is available in diameters 3.3 mm - 6.0 mm, and Medentika Preface is available in diameters 3.0 mm - 7.0 mm.

Differences between the subject devices and the predicate devices in specific dimensions and compatible implant systems do not impact substanial equivalence. Minor differences in the language of the indications for use statement between the subject device and the predicate devices do not affect the intended use to provide abutments for use with endosseous dental implants to provide prosthetic support in the maxilla and mandible.

CONCLUSION

The subject device and the predicate devices have intended use, have similar technological characteristics, and are made of similar materials. The subject device devices encompass the same range of physical dimensions, including diameter and angle of the subject and predicate devices are packaged in similar materials and are to be 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.)