CONELOG Titanium base CAD/CAM

K143337 · Altatec GmbH · NHA · Feb 17, 2015 · Dental

Device Facts

• Record ID: K143337
• Device Name: CONELOG Titanium base CAD/CAM
• Applicant: Altatec GmbH
• Product Code: NHA · Dental
• Decision Date: Feb 17, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3630
• Device Class: Class 2

Intended Use

Implant-prosthetic titanium abutment for CONELOG® implants with conical abutment connection, as a bonding base for hybrid abutments. The titanium base CAD/CAM for implant Ø3.3mm is designed only for hybrid abutments in the area of the upper lateral incisors and lower central and lateral incisors

Device Story

CONELOG Titanium base CAD/CAM is a titanium abutment used as a bonding base for hybrid abutments in dental implant procedures. It integrates with the Sirona CAD/CAM System to fabricate hybrid abutments with an angulation up to 20°. Available in four implant platform sizes (3.3 mm, 3.8 mm, 4.3 mm, 5.0 mm) and two gingival heights (0.8 mm, 2.0 mm). The device is used by dental professionals in a clinical setting. It functions as a structural interface between the endosseous implant and the custom-fabricated hybrid abutment, facilitating prosthetic restoration. The healthcare provider uses the CAD/CAM system to design the abutment, which is then bonded to the titanium base, providing a stable connection for the final dental prosthesis.

Clinical Evidence

No clinical data were submitted. Substantial equivalence is supported by non-clinical bench testing, specifically static and dynamic compression-bending testing conducted in accordance with ISO 14801 (Dentistry - Implants - Dynamic fatigue test for endosseous dental implants).

Technological Characteristics

Titanium abutment for endosseous dental implants. Available in four platform diameters (3.3-5.0 mm) and two gingival heights (0.8/2.0 mm). Designed for use with Sirona CAD/CAM System for hybrid abutment fabrication (up to 20° angle). Mechanical testing performed per ISO 14801. Sterilized using standard processes consistent with predicate devices.

Indications for Use

Indicated for patients requiring dental implant-prosthetic restoration using CONELOG® implants. The Ø3.3mm version is restricted to hybrid abutments for upper lateral incisors and lower central/lateral incisors.

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

• iSy Implant System (K133991)
• CONELOG® Implant System (K113779)
• CAMLOG® Implant System Modified Implants and Abutments (K083496)
• Sirona Dental CAD/CAM System (K111421)

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

February 17, 2015

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

Re: K143337

Trade/Device Name: CONELOG® Titanium base CAD/CAM Regulation Number: 21 CFR 872.4630 Regulation Name: Endosseous dental implant abutment Regulatory Class: Class II Product Code: NHA Dated: November 19, 2014 Received: November 20, 2014

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 [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,

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

Enclosures

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#### Indications for Use

510(k) Number (if known) K143337

Device Name

CONELOG® Titanium base CAD/CAM

Indications for Use (Describe)

CONELOG® Titanium base CAD/CAM

- Implant-prosthetic titanium abutment for CONELOG® implants with connection, as a bonding base for hybrid abutments.

- The Titanium base CAD/CAM for implant Ø 3.3 mm is designed only for hybrid abutments in the area of the upper lateral incisors and lower central and lateral incisors.

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 CONELOG® Titanium base CAD/CAM

February 12, 2015

# ADMINISTRATIVE INFORMATION

| Manufacturer Name: | Altatec GmbH | |
|-------------------------------------------|----------------------------|--|
| Maybachstrasse 5 | | |
| D-71299 Wimsheim, Germany | | |
| Telephone: | [phone] | |
| Fax: | [phone] | |
| Official Contact: | Dennis Pappas | |
| Senior Quality Auditor/Regulatory Affairs | | |
| (Henry Schein/CAMLOG USA) | | |
| 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: | CONELOG® Titanium base CAD/CAM |
|-----------------------------|------------------------------------|
| 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 |

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## INTENDED USE

## CONELOG® Titanium base CAD/CAM

- Implant-prosthetic titanium abutment for CONELOG® implants with conical abutment connection, as a bonding base for hybrid abutments.

- The titanium base CAD/CAM for implant Ø3.3mm is designed only for hybrid abutments in the area of the upper lateral incisors and lower central and lateral incisors

#### DEVICE DESCRIPTION

CONELOG Titanium base CAD/CAM is an abutment designed to be used with the Sirona CAD/CAM System in Coris ZI meso L and meso S to fabricate a hybrid abutment with an angle up to 20°.The Titanium base CAD/CAM is available in four implant platform sizes (3.3 mm 3.8 mm, 4.3 mm, and 5.0 mm), two gingival heights (0.8 mm or 2.0 mm) and is supplied with the corresponding screw. All design parameters are according to the cleared Sirona CAD/CAM System parameters.

#### PERFORMANCE DATA

Non-clinical testing data submitted, referenced, or relied upon to demonstrate substantial equivalence included: 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.

#### EQUIVALENCE TO MARKETED DEVICE

Altatec GmbH submits the following information in this Premarket Notification to demonstrate, for the purposes of FDA's regulation of medical devices, the subject device is substantially equivalent in indications and design principles to the following legally marketed predicate devices:

Altatec GmbH, iSy Implant System - K133991; Altatec GmbH, CONELOG® Implant System - K113779; Altatec GmbH, CAMLOG® Implant System Modified Implants and Abutments - K083496; and Sirona Dental Systems GmbH, Sirona Dental CAD/CAM System - K111421.

The primary predicated device for this submission is K133991. The subject device and the predicate devices encompass the same range of physical dimensions and characteristics, including implant diameter and length, and similar surface treatments. Any differences in the technological characteristics between the subject and predicate devices do not raise different issues of safety or effectiveness.

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

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Overall, the subject device has the following similarities to the predicate devices:

- has the same intended use, .
- uses the same operating principle, .
- incorporates the same basic design, ●
- incorporates the same or very similar materials, and .
- has similar packaging and is sterilized using the same materials and processes. .