(267 days)
No
The document describes physical dental abutments and their specifications, with no mention of AI or ML technology in the device description, intended use, or performance studies.
No
The device is described as an abutment, which provides support for prostheses, not for treating a disease or condition.
No
Explanation: The device is described as an abutment used to support dental prostheses on implants, which is a therapeutic rather than a diagnostic function. There is no mention of it being used to diagnose a medical condition.
No
The device description clearly states that the device includes physical CAD/CAM abutment designs made of titanium alloy and intended for use as a support for prostheses. It also mentions sterilization and biocompatibility testing, which are associated with physical devices, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for supporting dental prostheses in the maxilla or mandible of patients. This is a direct clinical application within the body.
- Device Description: The description details physical components (abutments) used in dental procedures.
- Lack of IVD Characteristics: The text does not mention any of the key characteristics of an IVD, such as:
- Analyzing samples from the human body (blood, urine, tissue, etc.).
- Providing information about a physiological state, health, disease, or congenital abnormality.
- Being used in vitro (outside the living body) for diagnostic purposes.
The device is a medical device used in vivo (within the living body) for structural support in dental restorations.
N/A
Intended Use / Indications for Use
Medentika TiBase CAD/CAM Abutments are intended for use with dental implants as a support for single or multiple tooth prostheses in the maxilla or mandible of a partially or fully edentulous patient.
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 mandible of a partially or fully edentulous patient.
Product codes (comma separated list FDA assigned to the subject device)
NHA
Device Description
The subject device includes two CAD/CAM abutment designs, the Medentika TiBase and the Medentika PreFace. The TiBase is a two-piece abutment used as a base when fabricating a zirconia superstructure and the PreFace is an abutment used in fabricating a full patient-specific abutment in titanium alloy. Both abutment designs are provided non-sterile and are intended to be sterilized by the clinician. Medentika Preface Abutment is available in diameters 3.0 mm to 7.0 mm. Medentika TiBase Abutment is available in diameters 3.25 mm to 7.0 mm. The specific diameters for each Series coordinate with the compatible implant systems and sizes listed below.
TiBase is available in two post designs. TiBase Generation 1 has a conically shaped post that is 4.0 mm high and TiBase Generation 2 has a parallel walled post shape that is 5.5 mm high. PreFace is available in one cylinder height of 20 mm. The maximum angle for abutments fabricated using TiBase or PreFace is 30°, the maximum gingival height is 6 mm and the minimum post height is 4 mm.
Medentika CAD/CAM Abutments are compatible with eleven dental implant systems. Each Medentika abutment series has a precision implant/abutment interface corresponding to the implant system predicate for that series.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
maxilla or mandible
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical testing data submitted, referenced, or relied upon to demonstrate substantial equivalence included engineering analysis and dimensional analysis for determination of compatibility using critical dimension measurements of the original manufacturers' components, static and dynamic compression-bending festing for the Medentika TiBase and Medentika PreFace according to ISO 14801 Dentistry – Implants – Dynamic fatigue test for endosseous dental implants, sterilization according to 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 and ISO 17665-2 Sterilization of health care products - Moist heat -Part 2: Guidance on the application of ISO 17665-1 to demonstrate an SAL of 10*, and biocompatibility testing for cytotoxicty according to ISO 10993-5 Biological evaluation of medical devices -- Part 5: Tests for in vitro c vtotoxicity. All materials conform to FDA recognized standards and no further biocompatibility testing was performed. The performance data included in this submission demonstrate substantial equivalence to the predicate devices listed above.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
K111935, K082545, K083192, K073713, K120822, K111935, K052272, K082545, K083192, K073713, K020646, K071370, K102436, K063341, K063286, K022562, K062129, K130222, K061410, K101732, K073075, K041509
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.)
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 23, 2015
Medentika GmbH c/o Ms. Linda Schulz Regulatory Affairs PaxMed International, LLC 12264 El Camino Real, Suite 400 San Diego, California 92130
Re: K150203
Trade/Device Name: Medentika CAD/CAM Abutments Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: September 23, 2015 Received: September 25, 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.
1
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 (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,
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
2
Indications for Use
510(k) Number (if known)
Device Name
Medentika CAD/CAM Abutments
Indications for Use (Describe)
Medentika TiBase CAD/CAM Abutments are intended for use with dental implants as a support for single or multiple tooth prostheses in the maxilla or mandible of a partially or fully edentulous patient.
| 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 | 3.5, 4.3, 5.0 | 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 | 3.5, 4.0, 4.5, 5.0 | 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 |
| Dentsply Friadent® Ankylos® | Y | 3.5, 4.5, 5.5, 7.0 | 3.5, 4.5, 5.5, 7.0 |
Medentika TiBase is intended for use with the Straumann® CARES® System. All digitally designed abutments for use with Medentika CAD/CAM Abutments are intended to be manufactured at a Straumann® CARES® validated milling center.
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.
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 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
Indications for Use
510(k) Number (if known)
Device Name
Medentika CAD/CAM Abutments
Indications for Use (Describe)
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 mandible of a partially or fully edentulous patient.
| 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 Abutments are intended to be manufactured at a Straumann® CARES® validated milling center.
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.
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 aqency 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."
4
510(k) Summary Medentika GmbH Medentika CAD/CAM Abutments
K150203
October 22, 2015
ADMINISTRATIVE INFORMATION
| Manufacturer Name | Medentika GmbH |
|---|---|
| Hammweg 8-10 | |
| 76549 Hügelsheim, Germany | |
| Telephone | +49 (0)7229-69912-0 |
| Fax | +49 (0)7229-69912-20 |
| Official Contact | Gerhard Polzer |
| Head of Quality Management / Regulatory Affairs | |
| Representative/Consultant | Linda K. Schulz |
| Floyd G. Larson | |
| 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 | Medentika CAD/CAM Abutments |
|---|---|
| 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 |
5
PREDICATES
The primary predicate for the Medentika TiBase is K120822, Straumann® CARES® Variobase™ Abutment. The primary predicate for the Medentika PreFace is K052272, Straumann C.A.R.E.S. Titanium Abutment.
Reference Predicates:
| K111935 | Ti-Base for individual milled Zirconium Abutment, 2-CONnect Abutment for Bridges |
|---|---|
| K082545 | Straumann® NN CARES® Titanium Abutment and NN CARES® Ceramic Abutment |
| K083192 | Inclusive® Titanium Abutment Blanks |
| K073713 | Blue Sky Bio Dental Implant System |
| K120822 | Straumann® CARES® Variobase™ Abutments |
| K111935 | Ti-Base for individual milled Zirconium Abutment, 2-CONnect Abutment for Bridges |
| K052272 | Straumann C.A.R.E.S. Titanium Abutment |
| K082545 | Straumann® NN CARES® Titanium Abutment and NN CARES Ceramic Abutment |
| K083192 | Inclusive® Titanium Abutment Blanks |
| K073713 | Blue Sky Bio Dental Implant System |
| K020646 | Replace™ HA Coated Implant |
| K071370 | NobelActive™ Internal Connection Implant |
| K102436 | NobelActive™ 3.0 |
| K063341 | 3i OSSEOTITE® Certain® Dental Implants |
| K063286 | OSSEOTITE® Dental Implants |
| K022562 | Various Brånemark System Implants – Immediate Function Indication |
| K062129 | P.004 Implants |
| K130222 | Straumann® Dental Implant System SLActive and Roxoid Product Families |
| K061410 | Zimmer Dental Implant System |
| K101732 | Astra Tech Implant System |
| K073075 | FRIADENT® Implant Systems |
| K041509 | ANKYLOS® Dental Implant System |
DEVICE DESCRIPTION
The subject device includes two CAD/CAM abutment designs, the Medentika TiBase and the Medentika PreFace. The TiBase is a two-piece abutment used as a base when fabricating a zirconia superstructure and the PreFace is an abutment used in fabricating a full patient-specific abutment in titanium alloy. Both abutment designs are provided non-sterile and are intended to be sterilized by the clinician. Medentika Preface Abutment is available in diameters 3.0 mm to 7.0 mm. Medentika TiBase Abutment is available in diameters 3.25 mm to 7.0 mm. The specific diameters for each Series coordinate with the compatible implant systems and sizes listed below.
TiBase is available in two post designs. TiBase Generation 1 has a conically shaped post that is 4.0 mm high and TiBase Generation 2 has a parallel walled post shape that is 5.5 mm high. PreFace is available in one cylinder height of 20 mm. The maximum angle for abutments fabricated using TiBase or PreFace is 30°, the maximum gingival height is 6 mm and the minimum post height is 4 mm.
Medentika CAD/CAM Abutments are compatible with eleven dental implant systems. Each Medentika abutment series has a precision implant/abutment interface corresponding to the implant system predicate for that series. Compatible sizes are as follows:
6
| Nobel Biocare Replace™ Select | E-Series | 3.5, 4.3, 5.0, 6.0 |
|---|---|---|
| Nobel Biocare NobelActive™ | F-Series | 3.0, 3.5, 4.3, 5.0 (3.0 PreFace Only) |
| Biomet 3i Osseotite® Certain® | H-Series | 3.25, 4.0, 5.0 |
| Biomet 3i Osseotite® | I-Series | 3.25, 3.75, 4.0, 5.0 |
| Nobel Biocare Brånemark | K-Series | 3.3, 3.75, 4.0, 5.0 |
| Straumann Bone Level | L-Series | 3.3, 4.1, 4.8 |
| Straumann Standard | N-Series | 3.3, 4.1, 4.8 |
| Zimmer Tapered Screw-Vent® | R-Series | 3.3, 3.7, 4.1, 4.7, 6.0 |
| Astra Tech OsseoSpeed™ | S-Series | 3.0, 3.5/4.0, 4.5/5.0 (3.0 PreFace Only) |
| Dentsply Friadent® Frialit/XiVE® | T-Series | 3.4, 3.8, 4.5, 5.5 |
| Dentsply Friadent® Ankylos® | Y-Series | 3.5, 4.5, 5.5, 7.0 (Y-Series TiBase Only) |
PERFORMANCE DATA
Non-clinical testing data submitted, referenced, or relied upon to demonstrate substantial equivalence included engineering analysis and dimensional analysis for determination of compatibility using critical dimension measurements of the original manufacturers' components, static and dynamic compression-bending festing for the Medentika TiBase and Medentika PreFace according to ISO 14801 Dentistry – Implants – Dynamic fatigue test for endosseous dental implants, sterilization according to 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 and ISO 17665-2 Sterilization of health care products - Moist heat -Part 2: Guidance on the application of ISO 17665-1 to demonstrate an SAL of 10*, and biocompatibility testing for cytotoxicty according to ISO 10993-5 Biological evaluation of medical devices -- Part 5: Tests for in vitro c vtotoxicity. All materials conform to FDA recognized standards and no further biocompatibility testing was performed. The performance data included in this submission demonstrate substantial equivalence to the predicate devices listed above.
7
INTENDED USE
TiBase
Medentika TiBase CAD/CAM Abutments are intended for use with dental implants as a support for single or multiple tooth prostheses in the maxilla or mandible of a partially or fully edentulous patient.
| 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 | 3.5, 4.3, 5.0 | 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 | 3.5, 4.0, 4.5, 5.0 | 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 |
| Dentsply Friadent® Ankylos® | Y | 3.5, 4.5, 5.5, 7.0 | 3.5, 4.5, 5.5, 7.0 |
Medentika TiBase is intended for use with the Straumann® CARES® System. All digitally designed abutments for use with Medentika CAD/CAM Abutments are intended to be manufactured at a Straumann® CARES® validated milling center.
PreFace
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 mandible of a partially or fully edentulous patient.
| 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 Abutments are intended to be manufactured at a Straumann® CARES® validated milling center.
8
EQUIVALENCE TO MARKETED DEVICE
Medentika CAD/CAM Abutments are compatible with eleven dental implant systems. Each Medentika abutment series has an implant/abutment interface corresponding to the implant system predicate for that series.
| Indications for Use | ||||
|---|---|---|---|---|
| Subject Device | Medentika TiBase CAD/CAM Abutments are intended for use with dental implants as a support for single or multiple tooth prostheses in the maxilla or mandible of a partially or fully edentulous patient. | |||
| Medentika GmbH | ||||
| Medentika CAD/CAM Abutments | 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 | 3.5, 4.3, 5.0 | 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 | 3.5, 4.0, 4.5, 5.0 | 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 | |
| Dentsply Friadent® Ankylos® | Y | 3.5, 4.5, 5.5, 7.0 | 3.5, 4.5, 5.5, 7.0 | |
| Medentika TiBase is intended for use with the Straumann® CARES® System. All digitally designed abutments for use with Medentika CAD/CAM Abutments are intended to be manufactured at a Straumann® CARES® valid milling center. | ||||
| Subject 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 mandible of a partially or fully edentulous patient. | |||
| Medentika GmbH | ||||
| Medentika CAD/CAM Abutments | 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 |
9
| Predicate Devices | |
|---|---|
| Institut Straumann | |
| AG | |
| Straumann® | |
| CARES® | |
| Variobase ™ | |
| Abutment | |
| K120822 | The Straumann® CARES® Variobase™ Abutment is a two-piece dental abutment consisting of the Straumann® |
| Variobase ™ Abutment and the Straumann® CARES® Variobase™ Coping which is intended to be placed onto | |
| Straumann dental implants to provide support for prosthetic reconstruction such as crowns and bridges. | |
| Straumann® CARES® Variobase ™ Abutments are indicated for screw-retained single tooth or cement-retained | |
| single tooth and bridge restorations. | |
| The Straumann® CARES® Variobase ™ Coping polycon® ae in combination with the Straumann® Variobase ™ | |
| Abutment is indicated for temporary (up to 180 days) dental restoration of a Straumann dental implant. | |
| Straumann USA | |
| Straumann | |
| C.A.R.E.S. | |
| Titanium | |
| Abutment | |
| K052272 | Abutments are intended to be placed into dental implants to provide support for prosthetic reconstructions such as |
| crowns or bridges. The Straumann C.A.R.E.S. Titanium Abutment is indicated for cemented restorations. The | |
| abutment can be used in single tooth replacements and multiple tooth restorations. |
The specific language of the Indications for Use Statement is not identical. However, the subject device and corresponding primary predicates are all abutments intended for use with endosseous dental implants for support of single-tooth or multiple-tooth restorations in the upper or lower arch, and therefore, have the same intended use.
| Subject Device | Primary Predicate Devices | ||
|---|---|---|---|
| Medentika GmbH | Institut Straumann AG | Straumann USA | |
| Medentika | |||
| CAD/CAM | |||
| Abutments | Straumann® CARES® | ||
| Variobase™ | |||
| Abutment | Straumann C.A.R.E.S. | ||
| Titanium Abutment | |||
| K120822 | K052272 | ||
| Design | |||
| Abutment | |||
| Design | Titanium Base, | ||
| CAD/CAM Blank | Titanium Base | CAD/CAM Blank | |
| Prosthesis | |||
| Attachment | Cement-retained | Cement-retained | Cement-retained |
| Restoration | Single-unit | ||
| Multi-unit | Single-unit | ||
| Multi-unit | Single-unit | ||
| Multi-unit | |||
| Abutment | |||
| Diameter | |||
| (mm) | 3.0 - 7.0 | 3.3 - 6.5 | 3.3 - 6.5 |
| Abutment | |||
| Angle | Up to 30° | Up to 30° | Up to 30° |
| Abutment/ | |||
| Implant | |||
| Interface | Indexed, | ||
| non-indexed | Indexed, | ||
| non-indexed | Indexed, | ||
| non-indexed |
Summary: Table of Substantial Equivalence – Abutment Design
10
| Subject Device | Primary Predicate Devices | ||
|---|---|---|---|
| Medentika GmbH | Institut Straumann AG | Straumann USA | |
| Medentika | |||
| CAD/CAM | |||
| Abutments | Straumann® CARES® | ||
| VariobaseTM | |||
| Abutment | |||
| K120822 | Straumann C.A.R.E.S. | ||
| Titanium Abutment | |||
| K052272 | |||
| Material | |||
| Abutment | Titanium Alloy | Titanium Alloy | Titanium Alloy |
| Screw | Titanium Alloy | Titanium Alloy | Titanium Alloy |
| Sterility | |||
| Abutment | Provided Non-Sterile | Provided Non-Sterile | Provided Non-Sterile |
| Screw | Provided Non-Sterile | Provided Non-Sterile | Provided Non-Sterile |
CONCLUSION
The data included in this submission demonstrate substantial equivalence to the predicate devices listed above.
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 to be sterilized using the same processes.