DD Solid Connect® CAD/CAM Abutments
Device Facts
| Record ID | K191111 |
|---|---|
| Device Name | DD Solid Connect® CAD/CAM Abutments |
| Applicant | Dental Direkt GmbH |
| Product Code | NHA · Dental |
| Decision Date | Jan 11, 2023 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 872.3630 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
DD Solid Connect® CAD/CAM Abutments are used to support prosthetic restorations in combination with endosseous dental implants in the upper and/or lower jaw. All digitally designed custom abutments for use with DD Solid Connect® CAD/CAM Abutments are to be sent to a Dental Direkt validated milling center for manufacture. DD Prefab abutments, for the Zimmer Biomet 3i Certain 3.4mm implant bodies, and DD Ti-Base 2CUT abutments, for the Altatech Camlog Screw-Line 3.3mm implant bodies, are indicated for maxillary lateral and mandibular central/lateral incisors only.
Device Story
System for CAD/CAM fabrication of custom dental abutments; includes DD Prefab (one-piece) and DD Ti-Base 2CUT/noLock (two-piece) components. Inputs: digital design files sent to validated milling center. Operation: titanium base (Ti-6Al-4V ELI) interfaces with endosseous implant; zirconia superstructure (ISO 13356) cemented to Ti-Base for two-piece designs. Used in dental clinics by trained personnel. Output: custom abutment supporting prosthetic restorations (cement or screw-retained). Benefits: patient-specific fit for single or multi-unit restorations; angulation correction up to 20°. Clinical decision-making: provides stable foundation for prosthetic teeth.
Clinical Evidence
Bench testing only. Fatigue testing per ISO 14801 and FDA guidance for root-form endosseous dental implants/abutments. Biocompatibility testing for cytotoxicity per ISO 10993-5. Sterilization validation per ISO 17665-1, ISO 11737-1, and ISO 11737-2. Dimensional analysis performed via reverse engineering of OEM components.
Technological Characteristics
Materials: Titanium Grade 5 (Ti-6Al-4V ELI) per ASTM/ISO standards; Zirconia per ISO 13356. Components: Prefab blanks, Ti-Bases, implant screws. Connectivity: CAD/CAM workflow (digital design to validated milling center). Sterilization: Provided non-sterile; validated for user sterilization. Design: Angulation correction up to 20°; wall thickness min 0.5mm.
Indications for Use
Indicated for partially or fully edentulous patients requiring prosthetic restoration support via endosseous dental implants in the maxilla or mandible. Specific contraindications: DD Prefab (Zimmer Biomet 3i Certain 3.4mm) and DD Ti-Base 2CUT (Altatech Camlog Screw-Line 3.3mm) limited to maxillary lateral and mandibular 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
- Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBases (K180564)
Reference Devices
- CreoDent Solidex® Customized Abutment (K202909)
- Inclusive® Titanium Abutments (K191222)
- DD Bio ZX2 (K142987)
- Multilink Hybrid Abutment Cement (K130436)
Submission Summary (Full Text)
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Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Dental Direkt GmbH Patrick Berz Manager Regulatory Affairs International Industriezentrum 106-108 Spenge, 32139 GERMANY
Re: K19111
Trade/Device Name: DD Solid Connect® CAD/CAM Abutments Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: December 13, 2022 Received: December 15, 2022
Dear Patrick Berz:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
# Andrew I. Steen -S
Andrew I. Steen Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic. Anesthesia. Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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# Indications for Use
510(k) Number (if known) K191111
Device Name DD Solid Connect® CAD/CAM Abutments
### Indications for Use (Describe)
DD Solid Connect® CAD/CAM Abutments are used to support prosthetic restorations in combination with endosseous dental implants in the upper and/or lower jaw.
All digitally designed custom abutments for use with DD Solid Connect® CAD/CAM Abutments are to be sent to a Dental Direkt validated milling center for manufacture.
DD Prefab abutments, for the Zimmer Biomet 3i Certain 3.4mm implant bodies, and DD Ti-Base 2CUT abutments, for the Altatech Camlog Screw-Line 3.3mm implant bodies, are indicated for maxillary lateral and mandibular central/lateral incisors only.
Compatible Implant Systems:
| Manufacturer | Implant System | Diameter (mm) |
|---------------------|------------------------|--------------------|
| - Altatech | Camlog | 3.3, 3.8, 4.3, 5.0 |
| - Nobel Biocare | Nobel Active | 3.5, 4.3/5.0 |
| - Nobel Biocare | Replace Select Tapered | 3.5, 4.3, 5.0 |
| - Dentsply Implants | AstraTech OsseoSpeed | 3.5/4.1, 4.5/5.0 |
| - Straumann | Bone Level | 3.3, 4.1/4.8 |
| - Straumann | SynOcta | 4.8, 6.5 |
| - Zimmer Dental | Tapered Screw-Vent | 3.5, 4.5, 5.7 |
| - Dentsply Implants | Xive | 3.4, 3.8, 4.5, 5.5 |
| - Dentsply Implants | Astra EV | 3.6, 4.2, 4.8, 5.4 |
| - Zimmer Biomet 3i | Certain | 3.4, 4.1/5.0 |
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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> Date: January 11, 2023
| 510(k) Summary | | |
|----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Submitter of 510(k) | Dental Direkt GmbH<br>Industriezentrum 106-108<br>32139 Spenge / Germany | |
| Contact Person | Patrick Berz, Manager Regulatory Affairs<br>Phone: +49 5225 86319-42<br>Fax: +49 5225 86319-99<br>E-mail: p.berz@dentaldirekt.de | |
| Establishment Registration Num-<br>ber | 3008347275 | |
| Date Prepared | January 11, 2023 | |
| Trade Name of Device | DD Solid Connect® CAD/CAM Abutments | |
| Common Name | Dental Abutment System | |
| Classification Name | Endosseous dental implant abutment | |
| Regulation Number | 21 CFR 872.3630 | |
| Product Code | NHA | |
| Panel | Dental | |
| Classification | Class 2 | |
| Primary Predicate Device | K180564 Medentika Abutment System, Medentika<br>CAD/CAM Abutments, Medentika CAD/CAM<br>TiBases | |
| Reference Devices | K202909 Creodent Prosthetics Ltd. - CreoDent Solidex®<br>Customized Abutment<br>K191222 Prismatik Dentalcraft, Inc. - Inclusive® Tita-<br>nium Abutments | |
| Indications for Use | DD Solid Connect® CAD/CAM Abutments are used to<br>support prosthetic restorations in combination with en-<br>dosseous dental implants in the upper and/or lower jaw.<br>All digitally designed custom abutments for use with DD<br>Solid Connect® CAD/CAM Abutments are to be sent to a | |
| | | |
| | | |
| | Dental Direkt validated milling center for manufacture. | |
| | DD Prefab abutments, for the Zimmer Biomet 3i Certain<br>3.4mm implant bodies, and DD Ti-Base 2CUT abut-<br>ments, for the Altatech Camlog Screw-Line 3.3mm im-<br>plant bodies, are indicated for maxillary lateral and man-<br>dibular central/lateral incisors only. | |
| | Compatible Implant Systems:<br>- Altatech: Camlog (3.3, 3.8, 4.3, 5.0)<br>- Nobel Biocare: Nobel Active (3.5, 4.3/5.0)<br>- Nobel Biocare: Replace Select Tapered (3.5, 4.3, 5.0)<br>- Dentsply Implants: Xive (3.4, 3.8, 4.5, 5.5)<br>- Straumann: Bone Level (3.3, 4.1/4.8)<br>- Straumann: SynOcta (4.8, 6.5)<br>- Zimmer Dental: Tapered Screw-Vent (3.5, 4.5, 5.7)<br>- Dentsply Implants: Astra Tech OsseoSpeed (3.5/4.0,<br>4.5/5.0)<br>- Dentsply Implants: Astra EV (3.6, 4.2, 4.8, 5.4) | |
| | - Zimmer Biomet 3i: Certain (3.4, 4.1/5.0) | |
| Device Description | The DD Solid Connect® CAD/CAM Abutments consist of<br>the following parts: DD Prefab, DD Ti-Base 2CUT and<br>DD Ti-Base 2CUT noLock. The DD Solid Connect<br>CAD/CAM Abutments are designed and made to individ-<br>ually fit the individual requirements for each patient.<br>DD Prefab attach directly to the following dental im-<br>plants: | |
| | - Altatech: Camlog Screw-Line (3.3, 3.8, 4.3, 5.0)<br>- Nobel Biocare: Nobel Active (3.5 NP, 4.3/5.0 RP)<br>- Nobel Biocare: Replace Select Tapered (3.5, 4.3, 5.0)<br>- Dentsply Implants: Astra Tech OsseoSpeed (3.5/4.0,<br>4.5/5.0)<br>- Straumann: Bone Level (3.3, 4.1/4.8)<br>- Straumann: SynOcta (4.8, 6.5)<br>- Zimmer Dental: Tapered Screw-Vent (3.5, 4.5, 5.7)<br>- Dentsply Implants: Xive (3.4, 3.8, 4.5, 5.5)<br>- Dentsply Implants: Astra EV (3.6, 4.2, 4.8, 5.4)<br>- Zimmer Biomet 3i: Certain (3.4, 4.1/5.0) | |
| | DD Ti-Base 2CUT / DD Ti-Base 2CUT noLock attach di-<br>rectly to the following dental implants:<br>- Altatech: Camlog Screw-Line (3.3, 3.8, 4.3, 5.0) | |
| | | |
| | The <i>DD Prefab</i> blanks are prefabricated components for<br>the metal-cutting production of individualized and one-<br>piece abutments using CAD/CAM technology.<br>The Ti-Bases ( <i>DD Ti-Base 2CUT / DD Ti-Base 2CUT no-Lock</i> ) are used as part of a two piece abutment, where<br>the base is premanufactured from titanium alloy (Ti-6Al-<br>4V ELI) and the top half is a CAD-CAM zirconia super-<br>structure, milled at a validated milling center. These<br>pieces are cemented together to form the final abutment.<br>All three implant components, the <i>DD Prefab</i> , the <i>DD Ti-Base 2CUT</i> and the <i>DD Ti-Base 2CUT noLock</i> are deliv-<br>ered each with an implant screw (DD Implant screw). | |
| Performance data | Fatigue testing according to ISO 14801 [FDA Recogni-<br>tion #4-195] and FDA guidance for Industry and FDA<br>Staff <i>Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous<br/>Dental Abutments</i> dated May 12, 2004.<br>Biocompatibilty testing for cytotoxicity according to ISO<br>10993-5 [FDA Recognition #2-245].<br>Sterilization validation according to ISO 17665-1 [FDA<br>Recognition #14-333], ISO 11737-1 [FDA Recognition<br>#14-577] and ISO 11737-2 [FDA Recognition #14-540]<br>Reverse engineering dimensional analysis was con-<br>ducted using OEM implant bodies, OEM abutments, and<br>OEM abutment screws. | |
| Material | DD Prefab, DD Ti-Base 2CUT (lower part), DD Ti-Base<br>2CUT noLock (lower part), DD Implant screw:<br><b>Titanium Grade 5 (Ti-6Al-4V ELI)</b><br>DD Ti-Base 2CUT (upper part) and DD Ti-Base noLock<br>(upper part):<br><b>Zirconia, ISO 13356</b> | |
| Technological<br>Characteristics | The <i>DD Solid Connect</i> ® CAD/CAM Abutments are a den-<br>tal system for the CAD/CAM manufacture of individual<br>abutments. The products are made of Titanium Grade 5<br>ELI, which is used since a long time for dental implants<br>and in medicine for bone and joint replacements, cardio-<br>vascular devices and surgical instruments. | |
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January 11, 2023
Date:
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#### Date: January 11, 2023
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Date: January 11, 2023
## DD Prefab:
The DD Prefab is used for fabricating customized abutments on implants in the upper and lower jaw for restorations with an angulation correction of max. 20° to the implant axis.
The following parameters are recommended for the design of the DD Prefab:
| Parameter | Specification |
|----------------------------|----------------|
| Abutment Post Height | 4 mm - 12.5 mm |
| Margin height | 0.5 mm - 6 mm |
| Diameter | 3.3 mm - 12 mm |
| Wall thickness | 0.5 mm minimum |
| Angle from axis of implant | 0° - 20° |
## DD Ti-Base 2CUT / DD Ti-Base 2CUT noLock:
The DD Ti-Base 2CUT is used for fixation of customized crown and abutment restorations incl. an anti-rotation device for the alignment of the abutment in the vertical axis for restorations with an angulation correction of max. 20° to the implant axis.
The DD Ti-Base 2CUT noLock is used for fixation of individualized bridge and bar restorations with an angulation correction of max. 20° to the implant axis.
For the top-half made of zirconia, our own zirconia materials DD Bio Z or DD Bio ZX2 (K142987) are recommended, while Multilink Hybrid Abutment Cement from lvoclar (K130436) is recommended as dental cement for fixation.
The following parameters are recommended for the design of the zirconia superstructure for DD Ti-Base 2CUT / DD Ti-Base 2CUT noLock:
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> Date: January 11, 2023
| Parameter | Specification |
|----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Abutment Post Height | 4 mm - 6.5 mm |
| Margin height | 0.5 mm - 6 mm |
| Diameter | 2.9 mm - 5 mm |
| Wall thickness | 0.5 mm minimum |
| Angle from axis of implant | 0° - 20° |
| Use in MR Environment | Non-clinical MR review was performed to evaluate the<br>metallic devices in the MR environment using scientific<br>rationale and published literature (e.g., Woods, Terry O.,<br>Jana G. Delfino, and Sunder Rajan. "Assessment of<br>Magnetically Induced Displacement Force and Torque<br>on Metal Alloys Used in Medical Devices." Journal of<br>Testing and Evaluation 49.2 (2019): 783-795), based on<br>the subject device components and material composi-<br>tion. Rationale addressed parameters per the FDA guid-<br>ance "Testing and Labeling Medical Devices for Safety in<br>the Magnetic Resonance (MR) Environment". |
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## Comparison with Predicate Device / Reference Devices
| Feature | Subject Device<br><i>DD Solid Connect®</i> | Predicate Device<br>Medentika Abutment<br>System, Medentika<br>CAD/CAM Abutments,<br>Medentika CAD/CAM Ti-<br>Bases<br><i>K180564</i> | Comment<br>(Equivalence with<br>Predicate Device) | Reference Device<br><i>CreoDent Solidex</i><br>Customized Abutment<br><i>K202909</i> | Reference Device<br><i>Inclusive® Titanium</i><br>Abutments<br><i>K191222</i> |
|----------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) | K191111 | K180564 | N/A | K202909 | K191222 |
| Product Code | NHA | NHA | Identical | NHA | NHA |
| Regulatory<br>Class | Class II | Class II | Identical | Class II | Class II |
| Regulation Num-<br>ber | 872.3630 | 872.3630 | Identical | 872.3630 | 872.3630 |
| Regulation<br>Name | Endosseous dental im-<br>plant abutment | Endosseous dental im-<br>plant abutment | Identical | Endosseous Dental<br>Implant Abutment, | Endosseous Dental<br>Implant Abutment, |
| Trade Name 1 | <i>DD Prefab</i> | Medentika Preface | N/A | <i>CreoDent Solidex®</i><br>Customized Abut-<br>ment | <i>Inclusive® Titanium</i><br>Abutments |
| Trade Name 2 | <i>DD Ti-Base 2CUT</i> | | N/A | N/A | N/A |
| Trade Name 3 | <i>DD Ti-Base 2CUT no-<br/>Lock</i> | Medentika Ti-Base | N/A | N/A | |
| Manufacturer | Dental Direkt GmbH | Medentika GmbH | N/A | CreoDent Prosthet-<br>ics, Ltd. | Prismatik Dental-<br>craft, Inc. |
| Intended Use | <i>DD Solid Connect®</i><br>CAD/CAM Abutments<br>are intended for auto-<br>mated CAD/CAM fabri-<br>cation of individual<br>dental abutments.<br>They are available for<br>various implant sys-<br>tems as they have the<br>corresponding prefab-<br>ricated implant inter-<br>faces. | Titanium base,<br>CAD/CAM Blank to be<br>machined provide to<br>the patient a custom<br>designed abutment for<br>the prosthetic restora-<br>tion | Similar | Titanium base,<br>CAD/CAM Blank to<br>be machined pro-<br>vide to the patient a<br>custom designed<br>abutment for the<br>prosthetic restora-<br>tion | Titanium base,<br>CAD/CAM Blank to<br>be machined provide<br>to the patient a cus-<br>tom designed abut-<br>ment for the pros-<br>thetic restoration |
| Indications for<br>use | <i>DD Solid Connect®</i><br>CAD/CAM Abutments<br>are used to support<br>prosthetic restorations | Medentika Preface<br>CAD/CAM Abutments<br>are intended for use<br>with dental implants as | Similar with re-<br>spect to:<br>- CAD/CAM | The <i>CreoDent<br/>Solidex®</i> Custom-<br>ized Abutment and<br>Screw is intended | <i>Inclusive® Titanium</i><br>Abutments are pre-<br>manufactured pros-<br>thetic components |
| Feature | Subject Device<br>DD Solid Connect® | Predicate Device<br>Medentika Abutment<br>System, Medentika<br>CAD/CAM Abutments,<br>Medentika CAD/CAM Ti-<br>Bases<br>K180564 | Comment<br>(Equivalence with<br>Predicate Device) | Reference Device<br>CreoDent Solidex<br>Customized Abutment<br>K202909 | Reference Device<br>Inclusive® Titanium<br>Abutments<br>K191222 |
| | in combination with en-<br>dosseous dental im-<br>plants in the upper<br>and/or lower jaw.<br>DD Prefab abutments,<br>for the Zimmer Biomet<br>3i Certain 3.4mm im-<br>plant bodies, and DD<br>Ti-Base 2CUT abut-<br>ments, for the Al-<br>tatech Camlog Screw-<br>Line 3.3mm implant<br>bodies, are indicated<br>for maxillary lateral<br>and mandibular cen-<br>tral/lateral incisors<br>only.<br>All digitally designed<br>custom abutments for<br>use with DD Solid<br>Connect® CAD/CAM<br>Abutments are to be<br>sent to a Dental Direkt<br>validated milling center<br>for manufacture. | a support for single or<br>multiple tooth prosthe-<br>ses in the maxilla or<br>mandible of a partially<br>for fully endentulous pa-<br>tient.<br>Medentika Preface is<br>intended for use with<br>the Straumann<br>CARES system. All<br>digitally designed abut-<br>ments for use with<br>Medentika CAD/CAM<br>Abutments are in-<br>tended to be manufac-<br>tured at a Straumann<br>Cares validated milling<br>center.<br>Medentika TiBase<br>CAD/CAM Abutments<br>are intended for use<br>with dental implants as<br>a support for single or<br>multiple tooth prosthe-<br>ses in the maxilla or<br>mandible of a partially | Use with dental<br>implants<br>Endosseous<br>Maxillary or<br>mandibular (up-<br>per or lower<br>jaw)<br>Prosthetic res-<br>taurations | for use with an en-<br>dosseous implant to<br>support a prosthetic<br>device in patents<br>who are partially or<br>completely edentu-<br>lous. The device<br>can be used for sin-<br>gle or multiple resto-<br>rations. The pros-<br>thesis can be ce-<br>mented or screw re-<br>tained to the abut-<br>ment. An abutment<br>screw is used to se-<br>cure the abutment<br>to the endosseous<br>implant. The Solidex<br>Abutment is com-<br>patible with the fol-<br>lowing dental im-<br>plants: (...)<br>All digitally designed<br>tiles for Creodont<br>Solides Customized<br>Abutments are to be<br>sent back to a Creo-<br>dont validated man- | connected to endos-<br>seous dental im-<br>plants in the edentu-<br>lous or partially<br>edentulous maxilla<br>or mandible to pro-<br>vide support for ce-<br>ment-retained or<br>screw-retained pros-<br>thetic restorations.<br>All digitally designed<br>abutments for use<br>with Inclusive Tita-<br>nium Abutments for<br>CAD/CAM are in-<br>tended to be sent to<br>a Prismatik Den-<br>talcraft validated<br>milling center for<br>manufacture. Com-<br>patible Implant Sys-<br>tem: Dentsply Im-<br>plants Astra Tech<br>Implant System®<br>EV. |
| | | for fully endentulous pa-<br>tient.<br>Table<br>Medentika TiBase is<br>intended for use with | | ufacturing facility for<br>manufacture. | |
| Feature | Subject Device<br>DD Solid Connect® | Predicate Device<br>Medentika Abutment<br>System, Medentika<br>CAD/CAM Abutments,<br>Medentika CAD/CAM Ti-<br>Bases<br>K180564 | Comment<br>(Equivalence with<br>Predicate Device) | Reference Device<br>CreoDent Solidex<br>Customized Abutment<br>K202909…
