Who is the manufacturer of DD Solid Connect® CAD/CAM Abutments (further DD Ti-Base 2CUT series)?

Dental Direkt GmbH filed the 510(k) submission for DD Solid Connect® CAD/CAM Abutments (further DD Ti-Base 2CUT series) (K230218).

What is the FDA product code for DD Solid Connect® CAD/CAM Abutments (further DD Ti-Base 2CUT series)?

NHA. It is classified under 21 CFR 872.3630 as a Class 2 device in the Dental panel.

What is the regulatory pathway for DD Solid Connect® CAD/CAM Abutments (further DD Ti-Base 2CUT series)?

510(k) clearance (submission type: Traditional).

What are the predicate devices for DD Solid Connect® CAD/CAM Abutments (further DD Ti-Base 2CUT series)?

DD Solid Connect® CAD/CAM Abutments (K191111).

Who can help prepare an FDA 510(k) submission like DD Solid Connect® CAD/CAM Abutments (further DD Ti-Base 2CUT series)?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

DD Solid Connect® CAD/CAM Abutments (further DD Ti-Base 2CUT series)

K230218 · Dental Direkt GmbH · NHA · Apr 25, 2023 · Dental

Device Facts

Record ID	K230218
Device Name	DD Solid Connect® CAD/CAM Abutments (further DD Ti-Base 2CUT series)
Applicant	Dental Direkt GmbH
Product Code	NHA · Dental
Decision Date	Apr 25, 2023
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 872.3630
Device Class	Class 2

Intended Use

DD Solid Connect® CAD/CAM Abutments (further DD Ti-Base 2CUT series) are intended for automated CAD/CAM fabrication of individual dental abutments. They are available for various implant systems as they have the corresponding prefabricated implant interfaces.

Device Story

Two-piece dental abutment system consisting of a premanufactured titanium alloy (Ti-6Al-4V ELI) base and a custom-milled zirconia superstructure. Used to support prosthetic restorations (crowns, bridges, bars) on endosseous dental implants. Designed via CAD/CAM software and manufactured at a validated milling center. The titanium base attaches to the implant; the zirconia top is cemented to the base. Used by dental professionals in clinical settings. Provides angulation correction up to 20 degrees. Benefits include patient-specific fit and prosthetic stability.

Clinical Evidence

Bench testing only. Fatigue testing performed according to ISO 14801 and FDA guidance for root-form endosseous dental implants. Biocompatibility (cytotoxicity per ISO 10993-5) and sterilization validation (ISO 17665-1, ISO 11737-1/2) leveraged from predicate device K191111. Reverse engineering dimensional analysis conducted against OEM components.

Technological Characteristics

Two-piece abutment system. Lower part: Titanium Grade 5 (Ti-6Al-4V ELI) per ASTM F136. Upper part: Zirconia per ISO 13356. Non-sterile. CAD/CAM manufactured. Compatible with various implant systems (Altatech, Nobel Biocare, Dentsply, Straumann, Zimmer).

Indications for Use

Indicated for supporting prosthetic restorations in combination with endosseous dental implants in the upper and/or lower jaw. Specific Ti-Base 2CUT abutments for Altatech Camlog Screw-Line 3.3mm, Dentsply Astra Tech OsseoSpeed 3.5mm, Dentsply Xive 3.4mm, Straumann Bone Level 3.3mm, Zimmer Biomet 3i Certain 3.4mm, and Zimmer Tapered Screw-Vent 3.5mm are indicated for maxillary lateral and mandibular central/lateral incisors only.

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

DD Solid Connect® CAD/CAM Abutments (K191111)

Reference Devices

DD Bio Z (K142987)
DD Bio ZX² (K142987)
Multilink Hybrid Abutment Cement (K130436)

Related Devices

K231411 — INNO SLA Submerged Hybrid Ti-Base System · Cowellmedi Co., Ltd. · Dec 20, 2023
K150296 — Biodenta Customized Abutment-Hybrid · Biodenta Swiss AG · Jul 2, 2015
K222913 — s-Clean Link Abutment · Dentis Co., Ltd. · Jan 13, 2023
K240603 — Ti-Base & Master Fix · Arum Dentistry Co., Ltd. · Jun 5, 2024
K191111 — DD Solid Connect® CAD/CAM Abutments · Dental Direkt GmbH · Jan 11, 2023

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue. Dental Direkt GmbH Patrick Berz Regulatory Affairs Manager Industriezentrum 106-108 Spenge, 32139 GERMANY Re: K230218 Trade/Device Name: DD Solid Connect® CAD/CAM Abutments (further DD Ti-Base 2CUT series) Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: January 26, 2023 Received: January 26, 2023 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. {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 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 Ouality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K230218 Device Name DD Solid Connect® CAD/CAM Abutments (further DD Ti-Base 2CUT series) Indications for Use (Describe) DD Solid Connect® CAD/CAM Abutments (further DD Ti-Base 2CUT series) are used to support prosthetic restorations in combination with endosseous dental implants in the upper and/or lower jaw. DD Ti-Base 2CUT abutments, for the Altatech Camlog Screw-Line 3.3mm implant bodies, Dentsply Implants Astra Tech OsseoSpeed 3.5mm implant bodies, Dentsply Implants Xive 3.4mm implant bodies, Straumann Bone Level 3.3mm implant bodies, Zimmer Biomet 31 Certain 3.4mm implant bodies and Zimmer Dental Tapered Screw-Vent 3.5mm implant bodies are indicated for maxillary lateral and mandibular central/lateral incisors only. All digitally designed custom abutments for use with DD Solid Connect® CAD/CAM Abutments (further DD Ti-Base 2CUT series) are to be sent to a Dental Direkt validated milling center for manufacture. 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) 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 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}------------------------------------------------ | | 510(k) Number: K230218 | |----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Date: 2023/04/25 | | | 510(k) Summary | | Submitter of 510(k) | Dental Direkt GmbH Industriezentrum 106-108 32139 Spenge / Germany | | Contact Person | Patrick Berz, Manager Regulatory Affairs Phone: +49 5225 86319-42 Fax: +49 5225 86319-99 E-mail: p.berz@dentaldirekt.de | | Establishment Registration Num- ber | 3008347275 | | Date Prepared | April 25, 2023 | | Trade Name of Device | DD Solid Connect® CAD/CAM Abutments (further DD Ti-Base 2CUT series) | | 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 | K191111 Dental Direkt GmbH - DD Solid Connect® CAD/CAM Abutments | | Indications for Use | DD Solid Connect® CAD/CAM Abutments (further DD Ti-Base 2CUT series) are used to support prosthetic restorations in combination with endosseous dental implants in the upper and/or lower jaw. DD Ti-Base 2CUT abutments, for the Altatech Camlog Screw- Line 3.3mm implant bodies, Dentsply Implants Astra Tech OsseoSpeed 3.5mm implant bodies, Dentsply Implants Xive 3.4mm implant bodies, Straumann Bone Level 3.3mm implant | | Date: | 2023/04/25 | | | bodies, Zimmer Biomet 3i Certain 3.4mm implant bodies and Zimmer Dental Tapered Screw-Vent 3.5mm implant bodies are indicated for maxillary lateral and mandibular central/lateral incisors only. | | | All digitally designed custom abutments for use with DD Solid Connect® CAD/CAM Abutments (further DD Ti-Base 2CUT series) are to be sent to a Dental Direkt validated milling center for manufacture. | | | 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 (further DD Ti- Base 2CUT series) consist of the following parts: DD Ti-Base 2CUT and DD Ti-Base 2CUT noLock. The DD Solid Connect® CAD/CAM Abutments (further DD Ti-Base 2CUT series) are designed and made to individually fit the individual requirements for each patient. DD Ti-Base 2CUT / DD Ti-Base 2CUT noLock attach directly to the following dental implants: - Altatech: Camlog (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) The Ti-Bases (DD Ti-Base 2CUT / DD Ti-Base 2CUT noLock) are used as part of a two piece abutment, where the base is | | Performance data | 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 two implant components, the DD Ti-Base 2CUT and the DD Ti-Base 2CUT noLock are delivered each with an implant screw (DD Implant screw). | | Material | DD Ti-Base 2CUT (lower part), DD Ti-Base 2CUT noLock (lower part), DD Implant screw: Titanium Grade 5 (Ti-6Al-4V ELI), conforming to ASTM F136 DD Ti-Base 2CUT (upper part) and DD Ti-Base noLock (upper part): Zirconia, ISO 13356 | | Technological Characteristics | The DD Solid Connect® CAD/CAM Abutments (further DD Ti- Base 2CUT series) are a dental system for the CAD/CAM manufacture of individual abutments. The products are made of Titanium Grade 5 ELI, which is used since a long time for dental implants and in medicine for bone and joint | | | Fatigue testing according to ISO 14801 [FDA Recognition #4- 195] and FDA guidance for Industry and FDA Staff Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments dated May 12, 2004. No new biocompatibility testing: Biocompatibilty testing for cytotoxicity according to ISO 10993-5 [FDA Recognition #2-245] leveraged from Predicate Device K191111 (worst case series). No new sterilization validation: Sterilization validation according to ISO 17665-1 [FDA Recognition #14-333], ISO 11737-1 [FDA Recognition #14- 577] and ISO 11737-2 [FDA Recognition #14-540] leveraged from Predicate Device K191111 (worst case series). Reverse engineering dimensional analysis was conducted using OEM implant bodies, OEM abutments, and OEM abutment screws. | | Date: | 2023/04/25 | {4}------------------------------------------------ 510(k) Number: K230218 {5}------------------------------------------------ 2023/04/25 510(k) Number: K230218 Date: {6}------------------------------------------------ K230218 510(k) Number: | replacements, cardiovascular devices and surgical instruments. | | | | |-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------|--|--| | 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 anqulation 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 Ivoclar (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: | | | | | | | | | | 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° | | | {7}------------------------------------------------ ### Comparison with Predicate Device | Feature | Subject Device | Predicate Device | Comment | | |------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------| | | DD Solid Connect® CAD/CAM Abutments (further DD Ti-Base 2CUT series) | DD Solid Connect® CAD/CAM Abutments | (Equivalence with Predicate Device) | | | 510(k) | This submission (K230218) | K191111 | N/A | | | Product Code | NHA | NHA | Identical | | | Regulatory Class | Class II | Class II | Identical | | | Regulation Number | 872.3630 | 872.3630 | Identical | | | Regulation Name | Endosseous dental implant abutment | Endosseous dental implant abutment | Identical | | | Trade Name 1 | DD Ti-Base 2CUT | DD Ti-Base 2CUT | Identical | | | Trade Name 2 | DD Ti-Base 2CUT noLock | DD Ti-Base 2CUT noLock | Identical | | | Trade Name 3 | N/A | DD Prefab | N/A (not part of this submission) | | | Manufacturer | Dental Direkt GmbH | Dental Direkt GmbH | Identical | | | Intended Use | DD Solid Connect®CAD/CAM Abutments (further DD Ti-Base 2CUT series) are intended for automated CAD/CAM fabrication of individual dental abutments. They are available for various implant systems as they have the corresponding prefabricated implant interfaces. | DD Solid Connect® CAD/CAM Abutments are intended for automated CAD/CAM fabrication of individual dental abutments. They are available for various implant systems as they have the corresponding prefabricated implant interfaces. | Identical | | | Indications for use | DD Solid Connect® CAD/CAM Abutments (further DD Ti-Base 2CUT series) are used to support prosthetic restorations in combination with endosseous dental implants in the upper and/or lower jaw. DD Ti-Base 2CUT abutments, for the Altatech Camlog Screw-Line 3.3mm implant bodies, | 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. DD Prefab abutments, for the Zimmer Biomet 3i Certain 3.4mm implant bodies, and DD Ti-Base 2CUT abutments, for the Altatech Camlog | Identical with respect to: CAD/CAM Use with dental implants Endosseous Maxillary or mandibular (upper or lower jaw) Prosthetic restaurations | | | Feature | Subject Device | Predicate Device | Comment | | | | DD Solid Connect® CAD/CAM Abutments (further DD Ti-Base 2CUT series) | DD Solid Connect® CAD/CAM Abutments | (Equivalence with Predicate Device) | | | | Dentsply Implants Astra Tech OsseoSpeed 3.5mm implant bodies, Dentsply Implants Xive 3.4mm implant bodies, Straumann Bone Level 3.3mm implant bodies, Zimmer Biomet 3i Certain 3.4mm implant bodies and Zimmer Dental Tapered Screw-Vent 3.5mm implant bodies are indicated for maxillary lateral and mandibular central/lateral incisors only. | Screw-Line 3.3mm implant bodies, are indicated for maxillary lateral and mandibular central/lateral incisors only. 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. | | | | | All digitally designed custom abutments for use with DD Solid Connect® CAD/CAM Abutments (further DD Ti-Base 2CUT series) are to be sent to a Dental Direkt validated milling center for manufacture. | | | | | Compatible Implant Systems (implant diameter in mm) | | | | | | | DD Ti-Base 2CUT / DD Ti-Base 2CUT noLock | DD Ti-Base 2CUT / DD Ti-Base 2CUT noLock | DD Prefab | | | - Altatech Camlog Screw-Line | 3.3, 3.8, 4.3, 5.0 | 3.3, 3.8, 4.3, 5.0 | 3.3, 3.8, 4.3, 5.0 | Identical | | - Nobel Biocare Nobel Active | 3.5 NP, 4.3/5.0 RP | N/A | 3.5 NP, 4.3/5.0 RP | Identical | | - Nobel Biocare Replace Select Tapered | 3.5, 4.3, 5.0 | N/A | 3.5, 4.3, 5.0 | Identical | | - Straumann Bone Level | 3.3, 4.1/4.8 | N/A | 3.3, 4.1/4.8 | Identical | | Feature | Subject Device | Predicate Device | Comment (Equivalence with Predicate Device) | | | - Straumann SynOcta | 4.8, 6.5 | 4.8, 6.5 | Identical | | | | DD Solid Connect ® CAD/CAM Abutments (further DD Ti-Base 2CUT series) | N/A | | | | | DD Ti-Base 2CUT / DD Ti-Base 2CUT noLock | DD Ti-Base 2CUT / DD Ti-Base 2CUT noLock DD Prefab | | | | - Zimmer Dental Tapered Screw-Vent | 3.5, 4.5, 5.7 | 3.5, 4.5, 5.7 | Identical | | | - Dentsply Implants Xive | 3.4, 3.8, 4.5, 5.5 | 3.4, 3.8, 4.5, 5.5 | Identical | | | - Dentsply Implants Astra Tech OsseoSpeed | 3.5/4.0, 4.5/5.0 | 3.5/4.0, 4.5/5.0 | Identical | | | - Zimmer Biomet 3i Certain | 3.4, 4.1/5.0 | 3.4, 4.1/5.0 | Identical | | | - Dentsply Implants Astra EV | 3.6, 4.2, 4.8, 5.4 | 3.6, 4.2, 4.8, 5.4 | Identical | | | Implant to Abutment Connection / Interface | Precision implant / abutment interface corresponding to the implant system for which it is used | Precision implant / abutment interface corresponding to the implant system for which it is used | Identical | | | Design parameters DD Ti-Base 2CUT / DD Ti-Base 2CUT noLock | | | | | | General parameters | | | | | | - Abutment type | Two-piece abutment | Two-piece abutment | Identical | | | - Prosthesis Attachment | Cement-retained, Screw-retained | Cement-retained, Screw-retained | Identical | | | - Restoration Types | Single-unit, Multi-unit | Single-unit, Multi-unit | Identical | | | Feature | Subject Device | Predicate Device | Comment | | | | DD Solid Connect® CAD/CAM Abutments (further DD Ti-Base 2CUT series) | DD Solid Connect® CAD/CAM Abutments | (Equivalence with Predicate Device) | | | - Angulation correction to the implant axis | 0° - 20° | 0° - 20° | Identical | | | - Retention area | 34 mm² | 34 mm²…