CAM Titanium Blanks

K160784 · Altatec GmbH · NHA · Sep 14, 2016 · Dental

Device Facts

• Record ID: K160784
• Device Name: CAM Titanium Blanks
• Applicant: Altatec GmbH
• Product Code: NHA · Dental
• Decision Date: Sep 14, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3630
• Device Class: Class 2

Indications for Use

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 Story

CAM Titanium Blanks are prefabricated titanium alloy cylinders with precision-machined interfaces for specific dental implant systems (CAMLOG, CONELOG, iSy). Used by clinicians and validated milling centers; CAD/CAM software designs custom abutments or healing caps from the blank. Output is a patient-specific, finished titanium abutment or healing cap. Used to support crowns, bridges, or overdentures. Benefits include patient-specific prosthetic fit and restoration of function in edentulous patients.

Clinical Evidence

No clinical data were included in this submission. Substantial equivalence is supported by non-clinical bench testing: sterilization validation (ISO 17665-1/2), biological evaluation (ISO 10993-1), MR testing (ASTM F2052, F2213, F2182, F2119), and static/dynamic compression-bending testing (ISO 14801).

Technological Characteristics

Material: Ti-6Al-4V ELI. Interface: Prefabricated precision-machined implant/abutment connection. Form factor: Cylindrical blanks for CAD/CAM milling. Angulation: Up to 30°. Sterilization: Validated per ISO 17665-1/2. Connectivity: Compatible with CAMLOG, CONELOG, and iSy implant systems.

Indications for Use

Indicated for partially or fully edentulous patients requiring single or multiple tooth prostheses supported by CAMLOG, CONELOG, or iSy endosseous dental implants in the maxilla or mandible.

Regulatory Classification

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.

Special Controls

*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.)

Predicate Devices

• Medentika CAD/CAM Abutments (K150203)

Reference Devices

• Low Profile Abutment (K092341)
• CAMLOG® Implant System (K083496)
• CONELOG® Implant System (K113779)
• iSy® Implant System (K133991)

Submission Summary (Full Text)

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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

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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 [phone] or [phone] 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 [phone] or [phone] 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

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# Indications for Use

510(k) Number (if known)

K160784

#### Device Name

CAM Titanium Blanks

#### Indications for Use (Describe)

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.

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

X Prescription Use (Part 21 CFR 801 Subpart D)

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# 510(k) Summary Altatec GmbH CAM Titanium Blanks

September 12, 2016

#### ADMINISTRATIVE INFORMATION

| Manufacturer Name | Altatec GmbH<br>Maybachstrasse 5<br>D-71299 Wimsheim, Germany | | | |
|---------------------------|---------------------------------------------------------------|--------------------|--|--|
| | Telephone: | [phone] | | |
| | Fax: | [phone] | | |
| 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: | [phone] | | |
| | Fax: | [phone] | | |
| | Email: | [e-mail] | | |
| | | [e-mail] | | |

# DEVICE NAME AND CLASSIFICATION

| Trade/Proprietary Name | CAM Titanium Blanks |
|--------------------------------------------|------------------------------------------------|
| Common Name | Dental Implant Abutment |
| Classification Name | Endosseous dental implant abutment |
| Classification Regulations<br>Product Code | 21 CFR 872.3630, Class II<br>NHA |
| Classification Panel:<br>Reviewing Branch: | Dental Products Panel<br>Dental 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

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#### INDICATIONS FOR USE

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 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

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).

# 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.

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#### Comparison of Indications for Use Statements

| | Indications for Use | | | | | | | | | | | |
|-------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------|--------|-------------------------|--------------------------------|--|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|--|
| Subject Device<br>Altatec GmbH<br>CAM Titanium Blanks<br>K160784 | CAM Titanium Blanks are intended for the fabrication of abutments and healing caps on CAMLOG® SCREW LINE and CAMLOG® ROOT-LINE<br>implants in the maxilla and mandible for the purpose of supporting single or multiple tooth prostheses of a partially or fully edentulous patient. Digitally<br>designed abutments fabricated with CAD/CAM techniques for use with CAM Titanium Blanks are intended to be sent to a CAMLOG validated milling<br>center for manufacture.<br><br>CAM Titanium Blanks are intended for the fabrication of abutments and healing caps on CONELOG® SCREW-LINE implants in the maxilla and<br>mandible for the purpose of supporting single or multiple tooth prostheses of a partially or fully edentulous patient. Digitally designed abutments<br>fabricated with CAD/CAM techniques for use with CAM Titanium Blanks are intended to be sent to a CAMLOG validated milling center for<br>manufacture.<br><br>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<br>purpose of supporting single or multiple tooth prostheses of a partially or fully edentulous patient. Digitally designed abutments fabricated with<br>CAD/CAM techniques for use with CAM Titanium Blanks are intended to be sent to a CAMLOG validated milling center for manufacture. | | | | | | | | | | | |
| Predicate Devices | | | | | | | | | | | | |
| Primary Predicate<br>Device | | | | | | | Medentika Preface CAD/CAM Abutments are intended for use with dental implants as a support for single or multiple tooth prostheses in the maxilla or<br>mandible of a partially or fully edentulous patient. | | | | | |
| Medentika GmbH<br>Medentika CAD/CAM<br>Abutments<br>K150203 | | 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/CAM<br>Abutments are intended to be manufactured at a Straumann® CARES® validated milling center. | | | | | | | | | | | |
| Reference Predicate Devices | | | | | | | | | | | | |
| Biomet 3i<br>Low Profile Abutment<br>K092341 | Biomet 3i Low Profile Abutments are intended for use as accessories to endosseous dental implants to support a prosthetic device in a partially or<br>completely edentulous patient. A dental abutment is intended for use to support single and multiple tooth prosthesis, in the mandible or maxilla. The<br>prosthesis is screw retained to the abutment. | | | | | | | | | | | |
| Altatec GmbH<br>CAMLOG Implant<br>System Modified<br>Implants and<br>Abutments<br>K083496 | Camlog Implant System implants are intended for immediate or delayed placement in the bone of the maxillary or mandibular arch. Camlog Implant<br>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<br>immediately loaded when good primary stability is achieved and the functional load is appropriate. | | | | | | | | | | | |
| Altatec GmbH<br>Conelog® Implant<br>System<br>K113779 | Implant Indications for Use<br>CONELOG® Implant System Implants are intended for immediate or delayed placement in the bone of the maxillary or mandibular arch. CONELOG®<br>Implant System Abutments are intended for use as support for crowns, bridges or overdentures. When a one-stage surgical approach is applied, the implant<br>may be immediately loaded when good primary stability is achieved and the functional load is appropriate.<br>CONELOG® Implants with 3.3 mm diameter have the following additional specific indications:<br>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<br>diameter implants, they should only be used under the following conditions:<br>* As single implants, they should be used only to replace mandibular incisors and/or maxillary lateral incisors.<br>* 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.<br>* Implants of Ø 3.3 mm are suitable for a partially edentulous arch when combined with implants of larger diameter for splinted superstructures. However,<br>the limited strength of the implants with Ø 3.3 mm must be taken into account.<br>* Avoid excessive mechanical stressing of the implants when using ball abutments in combination with Ø 3.3 mm implants.<br>* The healing time for Ø 3.3 mm implants is at least 12 weeks.<br>CONELOG® Implants with 7 mm length have the following additional specific indications:<br>CONELOG® SCREW-LINE Implants should only be used when there is not enough space for a longer implant. Delayed loading in single tooth<br>replacement is indicated with these implants. If the ratio of crown length to implant length is unfavorable the biomechanical risk factors have to be<br>considered and appropriate measures have to be taken by the dental professional.<br>Abutment Indications for Use<br>CONELOG® Abutments are intended to be used to fabricate prosthetic restorations in conjunction with CONELOG implants to support prostheses in the<br>maxillary and/or mandibular arch.<br>Vario SR Indications for Use<br>CONELOG® Vario SR components for crown and bridge restorations:<br>Occlusal screw-retained crown, bridge and bar constructions on CONELOG® implants in the anterior and posterior region of the maxilla and mandible<br>CONELOG® Vario SR components for bar restorations:<br>Anchorage of implant-supported ful dentures for the edentulous maxilla in conjunction with 4 or more CONELOG® implants and in the edentulous<br>mandible in conjunction with 2 or 4 or more CONELOG® implants. | | | | | | | | | | | |
| Altatec GmbH<br>iSy Implant System<br>K133991 | iSy® Implant System implants are intended for immediate or delayed placement in the bone of the maxillary or mandibular arch. iSy® Implant System<br>Abutments are intended for use as support for crowns, bridges or overdentures. When a one-stage surgical approach is applied, the implant may be<br>immediately loaded when good primary stability is achieved and the functional load is appropriate.…