(1356 days)
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.
The DD Solid Connect® CAD/CAM Abutments consist of the following parts: DD Prefab, DD Ti-Base 2CUT and DD Ti-Base 2CUT noLock. The DD Solid Connect CAD/CAM Abutments are designed and made to individually fit the individual requirements for each patient.
DD Prefab attach directly to the following dental implants:
- Altatech: Camlog Screw-Line (3.3, 3.8, 4.3, 5.0)
- Nobel Biocare: Nobel Active (3.5 NP, 4.3/5.0 RP)
- Nobel Biocare: Replace Select Tapered (3.5, 4.3, 5.0)
- Dentsply Implants: Astra Tech OsseoSpeed (3.5/4.0, 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)
DD Ti-Base 2CUT / DD Ti-Base 2CUT noLock attach directly to the following dental implants: - Altatech: Camlog Screw-Line (3.3, 3.8, 4.3, 5.0)
The DD Prefab blanks are prefabricated components for the metal-cutting production of individualized and one-piece abutments using CAD/CAM technology.
The Ti-Bases (DD Ti-Base 2CUT / DD Ti-Base 2CUT no-Lock) are used as part of a two piece abutment, where the base is premanufactured from titanium alloy (Ti-6Al-4V ELI) and the top half is a CAD-CAM zirconia superstructure, milled at a validated milling center. These pieces are cemented together to form the final abutment.
All three implant components, the DD Prefab, the DD Ti-Base 2CUT and the DD Ti-Base 2CUT noLock are delivered each with an implant screw (DD Implant screw).
The provided text is a 510(k) summary for a dental device (DD Solid Connect® CAD/CAM Abutments). It details the device's indications for use, technical characteristics, and a comparison to predicate devices to establish substantial equivalence. However, this document does not describe a study involving an AI/Machine Learning component with acceptance criteria, expert ground truth, or MRMC studies.
The "Performance data" section refers to:
- Fatigue testing according to ISO 14801 and FDA guidance for dental implants/abutments. This is mechanical testing to assess durability.
- Biocompatibility testing for cytotoxicity according to ISO 10993-5. This assesses the material's safety in contact with biological systems.
- Sterilization validation according to ISO 17665-1, ISO 11737-1, and ISO 11737-2. This verifies the sterilization process.
- Reverse engineering dimensional analysis using OEM implant bodies, OEM abutments, and OEM abutment screws. This is to ensure compatibility and fit.
These are standard engineering and biocompatibility tests for medical devices, not performance studies for AI/ML algorithms predicting or classifying medical conditions.
Therefore, I cannot extract the requested information (acceptance criteria, details of an AI/ML study, sample sizes for AI/ML test/training sets, expert ground truth, MRMC studies, or standalone performance) from the provided text as it pertains to the approval of a physical dental abutment and not an AI/ML diagnostic or predictive device.
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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 GmbHIndustriezentrum 106-10832139 Spenge / Germany | |
| Contact Person | Patrick Berz, Manager Regulatory AffairsPhone: +49 5225 86319-42Fax: +49 5225 86319-99E-mail: p.berz@dentaldirekt.de | |
| Establishment Registration Num-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, MedentikaCAD/CAM Abutments, Medentika CAD/CAMTiBases | |
| Reference Devices | K202909 Creodent Prosthetics Ltd. - CreoDent Solidex®Customized AbutmentK191222 Prismatik Dentalcraft, Inc. - Inclusive® Tita-nium Abutments | |
| Indications for Use | DD Solid Connect® CAD/CAM Abutments are used tosupport prosthetic restorations in combination with en-dosseous dental implants in the upper and/or lower jaw.All digitally designed custom abutments for use with DDSolid 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 Certain3.4mm implant bodies, and DD Ti-Base 2CUT abut-ments, for the Altatech Camlog Screw-Line 3.3mm im-plant bodies, are indicated for maxillary lateral and man-dibular central/lateral incisors only. | ||
| Compatible Implant Systems:- 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: Xive (3.4, 3.8, 4.5, 5.5)- 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: Astra Tech OsseoSpeed (3.5/4.0,4.5/5.0)- 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 ofthe following parts: DD Prefab, DD Ti-Base 2CUT andDD Ti-Base 2CUT noLock. The DD Solid ConnectCAD/CAM Abutments are designed and made to individ-ually fit the individual requirements for each patient.DD Prefab attach directly to the following dental im-plants: | |
| - Altatech: Camlog Screw-Line (3.3, 3.8, 4.3, 5.0)- Nobel Biocare: Nobel Active (3.5 NP, 4.3/5.0 RP)- Nobel Biocare: Replace Select Tapered (3.5, 4.3, 5.0)- Dentsply Implants: Astra Tech OsseoSpeed (3.5/4.0,4.5/5.0)- 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) | ||
| DD Ti-Base 2CUT / DD Ti-Base 2CUT noLock attach di-rectly to the following dental implants:- Altatech: Camlog Screw-Line (3.3, 3.8, 4.3, 5.0) | ||
| The DD Prefab blanks are prefabricated components forthe metal-cutting production of individualized and one-piece abutments using CAD/CAM technology.The Ti-Bases ( DD Ti-Base 2CUT / DD Ti-Base 2CUT no-Lock ) are used as part of a two piece abutment, wherethe base is premanufactured from titanium alloy (Ti-6Al-4V ELI) and the top half is a CAD-CAM zirconia super-structure, milled at a validated milling center. Thesepieces are cemented together to form the final abutment.All three implant components, the DD Prefab , the DD Ti-Base 2CUT and the DD Ti-Base 2CUT noLock are deliv-ered each with an implant screw (DD Implant screw). | ||
| Performance data | Fatigue testing according to ISO 14801 [FDA Recogni-tion #4-195] and FDA guidance for Industry and FDAStaff Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and EndosseousDental Abutments dated May 12, 2004.Biocompatibilty testing for cytotoxicity according to ISO10993-5 [FDA Recognition #2-245].Sterilization validation according to ISO 17665-1 [FDARecognition #14-333], ISO 11737-1 [FDA Recognition#14-577] and ISO 11737-2 [FDA Recognition #14-540]Reverse engineering dimensional analysis was con-ducted using OEM implant bodies, OEM abutments, andOEM abutment screws. | |
| Material | DD Prefab, DD Ti-Base 2CUT (lower part), DD Ti-Base2CUT noLock (lower part), DD Implant screw:Titanium Grade 5 (Ti-6Al-4V ELI)DD Ti-Base 2CUT (upper part) and DD Ti-Base noLock(upper part):Zirconia, ISO 13356 | |
| TechnologicalCharacteristics | The DD Solid Connect ® CAD/CAM Abutments are a den-tal system for the CAD/CAM manufacture of individualabutments. The products are made of Titanium Grade 5ELI, which is used since a long time for dental implantsand in medicine for bone and joint replacements, cardio-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 themetallic devices in the MR environment using scientificrationale and published literature (e.g., Woods, Terry O.,Jana G. Delfino, and Sunder Rajan. "Assessment ofMagnetically Induced Displacement Force and Torqueon Metal Alloys Used in Medical Devices." Journal ofTesting and Evaluation 49.2 (2019): 783-795), based onthe subject device components and material composi-tion. Rationale addressed parameters per the FDA guid-ance "Testing and Labeling Medical Devices for Safety inthe Magnetic Resonance (MR) Environment". |
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Comparison with Predicate Device / Reference Devices
| Feature | Subject DeviceDD Solid Connect® | Predicate DeviceMedentika AbutmentSystem, MedentikaCAD/CAM Abutments,Medentika CAD/CAM Ti-BasesK180564 | Comment(Equivalence withPredicate Device) | Reference DeviceCreoDent SolidexCustomized AbutmentK202909 | Reference DeviceInclusive® TitaniumAbutmentsK191222 |
|---|---|---|---|---|---|
| 510(k) | K191111 | K180564 | N/A | K202909 | K191222 |
| Product Code | NHA | NHA | Identical | NHA | NHA |
| RegulatoryClass | Class II | Class II | Identical | Class II | Class II |
| Regulation Num-ber | 872.3630 | 872.3630 | Identical | 872.3630 | 872.3630 |
| RegulationName | Endosseous dental im-plant abutment | Endosseous dental im-plant abutment | Identical | Endosseous DentalImplant Abutment, | Endosseous DentalImplant Abutment, |
| Trade Name 1 | DD Prefab | Medentika Preface | N/A | CreoDent Solidex®Customized Abut-ment | Inclusive® TitaniumAbutments |
| Trade Name 2 | DD Ti-Base 2CUT | N/A | N/A | N/A | |
| Trade Name 3 | DD Ti-Base 2CUT no-Lock | Medentika Ti-Base | N/A | N/A | |
| Manufacturer | Dental Direkt GmbH | Medentika GmbH | N/A | CreoDent Prosthet-ics, Ltd. | Prismatik Dental-craft, Inc. |
| Intended Use | DD Solid Connect®CAD/CAM Abutmentsare intended for auto-mated CAD/CAM fabri-cation of individualdental abutments.They are available forvarious implant sys-tems as they have thecorresponding prefab-ricated implant inter-faces. | Titanium base,CAD/CAM Blank to bemachined provide tothe patient a customdesigned abutment forthe prosthetic restora-tion | Similar | Titanium base,CAD/CAM Blank tobe machined pro-vide to the patient acustom designedabutment for theprosthetic restora-tion | Titanium base,CAD/CAM Blank tobe machined provideto the patient a cus-tom designed abut-ment for the pros-thetic restoration |
| Indications foruse | DD Solid Connect®CAD/CAM Abutmentsare used to supportprosthetic restorations | Medentika PrefaceCAD/CAM Abutmentsare intended for usewith dental implants as | Similar with re-spect to:- CAD/CAM | The CreoDentSolidex® Custom-ized Abutment andScrew is intended | Inclusive® TitaniumAbutments are pre-manufactured pros-thetic components |
| Feature | Subject DeviceDD Solid Connect® | Predicate DeviceMedentika AbutmentSystem, MedentikaCAD/CAM Abutments,Medentika CAD/CAM Ti-BasesK180564 | Comment(Equivalence withPredicate Device) | Reference DeviceCreoDent SolidexCustomized AbutmentK202909 | Reference DeviceInclusive® TitaniumAbutmentsK191222 |
| in combination with en-dosseous dental im-plants in the upperand/or lower jaw.DD Prefab abutments,for the Zimmer Biomet3i Certain 3.4mm im-plant bodies, and DDTi-Base 2CUT abut-ments, for the Al-tatech Camlog Screw-Line 3.3mm implantbodies, are indicatedfor maxillary lateraland mandibular cen-tral/lateral incisorsonly.All digitally designedcustom abutments foruse with DD SolidConnect® CAD/CAMAbutments are to besent to a Dental Direktvalidated milling centerfor manufacture. | a support for single ormultiple tooth prosthe-ses in the maxilla ormandible of a partiallyfor fully endentulous pa-tient.Medentika Preface isintended for use withthe StraumannCARES system. Alldigitally designed abut-ments for use withMedentika CAD/CAMAbutments are in-tended to be manufac-tured at a StraumannCares validated millingcenter.Medentika TiBaseCAD/CAM Abutmentsare intended for usewith dental implants asa support for single ormultiple tooth prosthe-ses in the maxilla ormandible of a partially | Use with dentalimplantsEndosseousMaxillary ormandibular (up-per or lowerjaw)Prosthetic res-taurations | for use with an en-dosseous implant tosupport a prostheticdevice in patentswho are partially orcompletely edentu-lous. The devicecan be used for sin-gle or multiple resto-rations. The pros-thesis can be ce-mented or screw re-tained to the abut-ment. An abutmentscrew is used to se-cure the abutmentto the endosseousimplant. The SolidexAbutment is com-patible with the fol-lowing dental im-plants: (...)All digitally designedtiles for CreodontSolides CustomizedAbutments are to besent back to a Creo-dont validated man- | connected to endos-seous dental im-plants in the edentu-lous or partiallyedentulous maxillaor mandible to pro-vide support for ce-ment-retained orscrew-retained pros-thetic restorations.All digitally designedabutments for usewith Inclusive Tita-nium Abutments forCAD/CAM are in-tended to be sent toa Prismatik Den-talcraft validatedmilling center formanufacture. Com-patible Implant Sys-tem: Dentsply Im-plants Astra TechImplant System®EV. | |
| for fully endentulous pa-tient.TableMedentika TiBase isintended for use with | ufacturing facility formanufacture. | ||||
| Feature | Subject DeviceDD Solid Connect® | Predicate DeviceMedentika AbutmentSystem, MedentikaCAD/CAM Abutments,Medentika CAD/CAM Ti-BasesK180564 | Comment(Equivalence withPredicate Device) | Reference DeviceCreoDent SolidexCustomized AbutmentK202909 | Reference DeviceInclusive® TitaniumAbutmentsK191222 |
| the StraumannCARES system. Alldigitally designed abut-ments for use withMedentika CAD/CAMAbutments are in-tended to be manufac-tured at a StraumannCares validated millingcenter. | |||||
| Compatible Im-plant Systems(implant diameterin mm) | The DD Solid Con-nect® CAD/CAM Abut-ments are compatibleto the following 10 im-plant systems currentlymarketed: | Medentika CAD/CAMAbutments are com-patible with 11 dentalimplant systems: | N/A | Compatibility isclaimed with the fol-lowing implant sys-tems: | Compatibility isclaimed with the fol-lowing implant sys-tems: |
| - Altatech Cam-log Screw-Line | 3.3, 3.8, 4.3, 5.0 | C-Series | Identical to Refer-ence Device(K202909) | 3.3, 3.8, 4.3, 5.0 | N/A |
| - Nobel BiocareNobel Active | 3.5 NP, 4.3/5.0 RP | 3.5, 3.9 (4.3), 3.9 (5.0) | Identical | 3.5, 3.9 (4.3) | N/A |
| - Nobel BiocareReplace SelectTapered | 3.5, 4.3, 5.0 | 3.5, 4.3, 5.0, 6.0(Nobel Biocare Re-place™ Select) | Identical | N/A | N/A |
| - StraumannBone Level | 3.3, 4.1/4.8 | 3.3, 4.1, 4.8 | Identical | 3.3, 4.1/4.8 | N/A |
| - StraumannSynOcta | 4.8, 6.5 | 3.5 (NNC), 4.8, 6.5(Straumann StandardN-Series) | Identical | N/A | N/A |
| Feature | Subject DeviceDD Solid Connect® | Predicate DeviceMedentika AbutmentSystem, MedentikaCAD/CAM Abutments,Medentika CAD/CAM Ti-BasesK180564 | Comment(Equivalence withPredicate Device) | Reference DeviceCreoDent SolidexCustomized AbutmentK202909 | Reference DeviceInclusive® TitaniumAbutmentsK191222 |
| - Zimmer DentalTapered Screw-Vent | 3.5, 4.5, 5.7 | 3.5, 4.5, 5.7 | Identical | 3.5, 4.5, 5.7 | N/A |
| - Dentsply Im-plants Xive | 3.4, 3.8, 4.5, 5.5 | 3.4, 3.8, 4.5, 5.5 | Identical | N/A | N/A |
| - Dentsply Im-plants AstraTech Osse-oSpeed | 3.5/4.0, 4.5/5.0 | 3.5, 4.0, 4.5, 5.0 | Identical | N/A | N/A |
| - Zimmer Biomet3i Certain | 3.4, 4.1/5.0 | 3.4, 4.1, 5.0 | Identical | 3.4, 4.1, 5.0, 6.0 | N/A |
| - Dentsply Im-plants Astra EV | 3.6, 4.2, 4.8, 5.4 | 3.6, 4.2, 4.8, 5.4 | Identical | N/A | Dentsply ImplantsAstra EV 3.6, 4.2,4.8, 5.4 |
| Implant to Abut-ment Connec-tion / Interface | Precision implant /abutment interfacecorresponding to theimplant system forwhich it is used | Precision implant /abutment interfacecorresponding to theimplant system forwhich it is used | Identical | Precision implant /abutment interfacecorresponding to theimplant system forwhich it is used | Precision implant /abutment interfacecorresponding to theimplant system forwhich it is used |
| DD Prefab | One-piece abutment | One-piece abutment | Identical | One-piece abutment | One-piece abutment |
| - Post Height | 4 mm - 12,5 mm | 4 - 15 mm | Similar | 5 mm - 10 mm | Min. 4 mm |
| - Gingival Height | 0,5 mm - 6 mm | Max. 6 mm (Minimumnot stated) | Identical (Refer-ence Device 2) | 1 mm - 5 mm | 0,5 mm - 6 mm |
| - Diameter | 3,3 mm - 12 mm | Max. 13 mm (Minimumnot stated) | Similar | Max. 5 mm | Max. 9,4 mm |
| - Angulation cor-rection to the im-plant axis | 0° - 20° | 0° - 21° | Identical (Refer-ence Device 1 + 2) | 0° - 20° | 0° - 20° |
| Feature | Subject DeviceDD Solid Connect® | Predicate DeviceMedentika AbutmentSystem, MedentikaCAD/CAM Abutments,Medentika CAD/CAM Ti-BasesK180564 | Comment(Equivalence withPredicate Device) | Reference DeviceCreoDent SolidexCustomized AbutmentK202909 | Reference DeviceInclusive® TitaniumAbutmentsK191222 |
| - Wall Thickness | Min. 0,5 mm | Min. 0,5 mm | Identical | Min. 0,68 mm | Not stated in 510(k) |
| - Prosthesis At-tachment | Cement-retained,Screw-retained | Cement-retained,Screw-retained | Identical | Cement-retained,Screw-retained | Cement-retained,Screw-retained |
| - RestorationTypes | Single-unit, Multi-unit | Single-unit, Multi-unit | Identical | Single-unit, Multi-unit | Single-unit, Multi-unit |
| DD Ti-Base2CUT / DD Ti-Base 2CUT no-Lock | Two-piece abutment | Two-piece abutment | Identical | N/A | Two-piece abutment |
| - Prosthesis At-tachment | Cement-retained,Screw-retained | Cement-retained,Screw-retained | Identical | N/A | Cement-retained,Screw-retained |
| - RestorationTypes | Single-unit, Multi-unit | Single-unit, Multi-unit | Identical | N/A | Single-unit, Multi-unit |
| - Angulation cor-rection to theimplant axis | 0° - 20° | 0° - 21° | Similar | N/A | Straight |
| - Retention area | 34 mm² | 34 mm² | Identical | N/A | N/A |
| - Prosthetic PostHeight | 4 mm - 6,5 mm | 4 - 15 mm | Similar | N/A | 4 mm - 5,5 mm |
| - Gingival Height | 0,5 mm - 6 mm | Max. 6 mm (Minimumnot stated) | Identical (Refer-ence Device 2) | N/A | 0,5 mm - 6 mm |
| - Diameter | 2,7 mm - 7 mm | Max. 10 mm (Minimumnot stated) | Similar | N/A | Not stated in 510(k) |
| - Wall Thickness | Min. 0,5 mm | Min. 0,5 mm | Identical | N/A | Not stated in 510(k) |
| One-piece abut-ment | Ti-6Al-4V ELI | Ti-6Al-4V ELI | Identical | Ti-6Al-4V ELI | Ti-6Al-4V ELI |
| Feature | Subject DeviceDD Solid Connect® | Predicate DeviceMedentika AbutmentSystem, MedentikaCAD/CAM Abutments,Medentika CAD/CAM Ti-BasesK180564 | Comment(Equivalence withPredicate Device) | Reference DeviceCreoDent SolidexCustomized AbutmentK202909 | Reference DeviceInclusive® TitaniumAbutmentsK191222 |
| Two-piece abut-ment (lower part) | Ti-6Al-4V ELI | Ti-6Al-4V ELI | Identical | N/A | Ti-6AL-4V ELI |
| Two-piece abut-ment (upperpart) | Zirconia, ISO 13356 | Zirconia, ISO 13356 | Identical | N/A | Zirconia, ISO 13356 |
| Screw (fixation) | Ti-6Al-4V ELI | Ti-6Al-4V ELI | Identical | Ti-6AL-4V ELI | Ti-6AL-4V ELI |
| Sterility | Provided Non-sterile | Provided Non-sterile | Identical | Provided Non-sterile | Provided Non-sterile |
Traditional 510(k) DD Solid Connect
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Substantial Equivalence Conclusion
The product DD Solid Connect® CAD/CAM Abutments and its accessory is as safe and effective as the predicate device / reference devices when used as instructed by knowledgeable and trained dental personnel. The predicates with respect to the intended use and the indications for use. The same fundamental scientific technology compared to the predicate devices / reference devices, as it uses the same manufacturing technology.
The scientific methods to evaluate the technological characteristics can be therefore considered as acceptable and the respective data demonstrate that the product is substantially equivalent to the predicate device.
The IFU's for the subject device is nearly identical to that of the primary predicate device (K180564) and the reference devices (K202909; K19122). The minor differences in language of the subject device and the primary predicate device / reference devices include the compatible implant systems and, therefore, do not affect the intended use. An additional difference is that the DD Prefab abutments, for the Zimmer Biomet 31 Certain 3.4mm implant bodies, and the DD Ti-Base 2CUT abutments, for the Altatech Camlog Screw-Line 3.3mm implant bodies, are indicated for maxillary lateral incisors only. This language is included in the IFU's to support substantial equivalence of the Zimmer Biomet 31 Certain (only DD Prefab) and Camlog Screw-Line (only DD Ti-Base 2CUT) compatibility as related to the performance bench testing provided in this submission.
Due to the points mentioned above Dental Direkt GmbH believes that the new device is substantially equivalent to the legally marketed predicate device / reference devices.
§ 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.)