(89 days)
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)
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 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).
The provided text describes Dental Direkt GmbH's K230218 510(k) submission for "DD Solid Connect® CAD/CAM Abutments (further DD Ti-Base 2CUT series)." This submission aims to demonstrate substantial equivalence to a legally marketed predicate device (K191111).
The document does not describe a study that uses a test set, expert readers, or AI performance metrics. Instead, it focuses on demonstrating substantial equivalence through a comparison of the subject device with a predicate device, relying on material, manufacturing, and general design similarities, along with performance testing according to established standards for dental implants.
Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, expert involvement, adjudication, MRMC studies, standalone performance, and ground truth establishment cannot be extracted from this document as it pertains to a different type of device evaluation (substantial equivalence based on physical and functional comparison to a predicate, rather than an AI/software performance study).
The "Performance data" section (Page 4, last entry of the large table) explicitly states:
- "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."
This indicates that the performance evaluation relies on bench testing (fatigue), leveraging existing biocompatibility and sterilization data from the predicate device, and dimensional analysis, not on clinical studies involving test sets, human readers, or AI.
In summary, the provided document does not contain the information required to answer the prompt as it pertains to AI/software performance studies. The device is a physical dental abutment, and its clearance is based on substantial equivalence to a predicate device through engineering and material comparisons and standardized physical testing.
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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.
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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 Ouality Center for Devices and Radiological Health
Enclosure
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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)
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| 510(k) Number:K230218 | |
|---|---|
| Date:2023/04/25 | |
| 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 | April 25, 2023 |
| Trade Name of Device | DD Solid Connect® CAD/CAM Abutments (further DD Ti-Base2CUT 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/CAMAbutments |
| Indications for Use | DD Solid Connect® CAD/CAM Abutments (further DD Ti-Base2CUT series) are used to support prosthetic restorations incombination with endosseous dental implants in the upperand/or lower jaw.DD Ti-Base 2CUT abutments, for the Altatech Camlog Screw-Line 3.3mm implant bodies, Dentsply Implants Astra TechOsseoSpeed 3.5mm implant bodies, Dentsply Implants Xive3.4mm implant bodies, Straumann Bone Level 3.3mm implant |
| Date: | 2023/04/25 |
| bodies, Zimmer Biomet 3i Certain 3.4mm implant bodies andZimmer Dental Tapered Screw-Vent 3.5mm implant bodiesare indicated for maxillary lateral and mandibularcentral/lateral incisors only. | |
| All digitally designed custom abutments for use with DD SolidConnect® CAD/CAM Abutments (further DD Ti-Base 2CUTseries) are to be sent to aDental 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-Base2CUT and DD Ti-Base 2CUT noLock. The DD Solid Connect®CAD/CAM Abutments (further DD Ti-Base 2CUT series) aredesigned and made to individually fit the individualrequirements for each patient.DD Ti-Base 2CUT / DD Ti-Base 2CUT noLock attach directlyto 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 thetop half is a CAD-CAM zirconia superstructure, milled at avalidated milling center. These pieces are cemented togetherto form the final abutment.All two implant components, the DD Ti-Base 2CUT and theDD Ti-Base 2CUT noLock are delivered each with an implantscrew (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 F136DD Ti-Base 2CUT (upper part) and DD Ti-Base noLock (upperpart):Zirconia, ISO 13356 |
| TechnologicalCharacteristics | The DD Solid Connect® CAD/CAM Abutments (further DD Ti-Base 2CUT series) are a dental system for the CAD/CAMmanufacture of individual abutments. The products are madeof Titanium Grade 5 ELI, which is used since a long time fordental 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 IISpecial Controls Guidance Document: Root-form EndosseousDental Implants and Endosseous Dental Abutments datedMay 12, 2004.No new biocompatibility testing:Biocompatibilty testing for cytotoxicity according to ISO10993-5 [FDA Recognition #2-245] leveraged from PredicateDevice K191111 (worst case series).No new sterilization validation: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] leveragedfrom Predicate Device K191111 (worst case series).Reverse engineering dimensional analysis was conductedusing OEM implant bodies, OEM abutments, and OEMabutment screws. | |
| Date: | 2023/04/25 |
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510(k) Number: K230218
{5}------------------------------------------------
2023/04/25
510(k) Number: K230218
Date:
{6}------------------------------------------------
K230218 510(k) Number:
| replacements, cardiovascular devices and surgicalinstruments. | |||
|---|---|---|---|
| The DD Ti-Base 2CUT is used for fixation of customizedcrown and abutment restorations incl. an anti-rotation devicefor the alignment of the abutment in the vertical axis forrestorations with an angulation correction of max. 20° to theimplant axis. | |||
| The DD Ti-Base 2CUT noLock is used for fixation ofindividualized bridge and bar restorations with an anqulationcorrection of max. 20° to the implant axis. | |||
| For the top-half made of zirconia, our own zirconia materialsDD Bio Z or DD Bio ZX² (K142987) are recommended, whileMultilink Hybrid Abutment Cement from Ivoclar (K130436) isrecommended as dental cement for fixation. | |||
| The following parameters are recommended for the design ofthe zirconia superstructure for DD Ti-Base 2CUT / DD Ti-Base2CUT 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° |
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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 PredicateDevice) | ||
| 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 thissubmission) | |
| Manufacturer | Dental Direkt GmbH | Dental Direkt GmbH | Identical | |
| Intended Use | DD Solid Connect®CAD/CAM Abutments(further DD Ti-Base 2CUT series) areintended for automated CAD/CAM fabricationof individual dental abutments. They areavailable for various implant systems as theyhave the corresponding prefabricated implantinterfaces. | DD Solid Connect® CAD/CAM Abutments areintended for automated CAD/CAM fabricationof individual dental abutments. They areavailable for various implant systems as theyhave the corresponding prefabricated implantinterfaces. | Identical | |
| Indications for use | DD Solid Connect® CAD/CAM Abutments(further DD Ti-Base 2CUT series) are used tosupport prosthetic restorations in combinationwith endosseous dental implants in the upperand/or lower jaw.DD Ti-Base 2CUT abutments, for the AltatechCamlog Screw-Line 3.3mm implant bodies, | DD Solid Connect® CAD/CAM Abutments areused to support prosthetic restorations incombination with endosseous dental implantsin the upper and/or lower jaw.DD Prefab abutments, for the Zimmer Biomet 3iCertain 3.4mm implant bodies, and DD Ti-Base2CUT abutments, for the Altatech Camlog | Identical with respect to:CAD/CAMUse with dental implantsEndosseousMaxillary 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 PredicateDevice) | ||
| Dentsply Implants Astra Tech OsseoSpeed3.5mm implant bodies, Dentsply Implants Xive3.4mm implant bodies, Straumann Bone Level3.3mm implant bodies, Zimmer Biomet 3iCertain 3.4mm implant bodies and ZimmerDental Tapered Screw-Vent 3.5mm implantbodies are indicated for maxillary lateral andmandibular central/lateral incisors only. | Screw-Line 3.3mm implant bodies, areindicated for maxillary lateral and mandibularcentral/lateral incisors only.All digitally designed custom abutments for usewith DD Solid Connect® CAD/CAM Abutmentsare to be sent to a Dental Direkt validatedmilling center for manufacture. | |||
| All digitally designed custom abutments foruse with DD Solid Connect® CAD/CAMAbutments (further DD Ti-Base 2CUT series)are to be sent to a Dental Direkt validatedmilling center for manufacture. | ||||
| Compatible Implant Systems(implant diameter in mm) | ||||
| DD Ti-Base 2CUT / DD Ti-Base 2CUTnoLock | DD Ti-Base 2CUT /DD Ti-Base 2CUTnoLock | DD Prefab | ||
| - Altatech CamlogScrew-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 BiocareNobel Active | 3.5 NP, 4.3/5.0 RP | N/A | 3.5 NP, 4.3/5.0 RP | Identical |
| - Nobel BiocareReplace SelectTapered | 3.5, 4.3, 5.0 | N/A | 3.5, 4.3, 5.0 | Identical |
| - Straumann BoneLevel | 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) | |
| - StraumannSynOcta | 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 noLockDD Prefab | |||
| - Zimmer DentalTapered Screw-Vent | 3.5, 4.5, 5.7 | 3.5, 4.5, 5.7 | Identical | |
| - Dentsply ImplantsXive | 3.4, 3.8, 4.5, 5.5 | 3.4, 3.8, 4.5, 5.5 | Identical | |
| - Dentsply ImplantsAstra TechOsseoSpeed | 3.5/4.0, 4.5/5.0 | 3.5/4.0, 4.5/5.0 | Identical | |
| - Zimmer Biomet 3iCertain | 3.4, 4.1/5.0 | 3.4, 4.1/5.0 | Identical | |
| - Dentsply ImplantsAstra EV | 3.6, 4.2, 4.8, 5.4 | 3.6, 4.2, 4.8, 5.4 | Identical | |
| Implant to AbutmentConnection / 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 | |
| - ProsthesisAttachment | 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 PredicateDevice) | ||
| - Angulationcorrection to theimplant axis | 0° - 20° | 0° - 20° | Identical | |
| - Retention area | 34 mm² | 34 mm² | Identical | |
| Parameters for the design of the zirconia top half | ||||
| - Prosthetic PostHeight | 4 mm - 6,5 mm | 4 mm - 6,5 mm | Identical | |
| - Gingival Height | 0,5 mm - 6 mm | 0,5 mm - 6 mm | Identical | |
| - Diameter | 2,7 mm - 7 mm | 2,7 mm - 7 mm | Identical | |
| - Wall Thickness | Min. 0,5 mm | Min. 0,5 mm | Identical | |
| Material | ||||
| One-piece abutment | N/A | N/A | N/A (not part of thissubmission) | |
| Two-piece abutment(lower part) | Ti-6Al-4V ELI | Ti-6Al-4V ELI | Identical | |
| Two-piece abutment(upper part) | Zirconia, ISO 13356 | Zirconia, ISO 13356 | Identical | |
| Screw (fixation) | Ti-6Al-4V ELI | Ti-6Al-4V ELI | Identical | |
| Sterility | Provided Non-sterile | Provided Non-sterile | Identical |
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{9}------------------------------------------------
{10}------------------------------------------------
Substantial Equivalence Conclusion
The subject device DD Solid Connect® CAD/CAM Abutments (further DD Ti-Base 2CUT series) is as safe and effective as the predicate device (K19111) when used as instructed by knowledgeable and trained dental personnel. The product is nearly
{11}------------------------------------------------
identical to its predicate device with respect to the Indical with respect to the Intended Use. Since the product DD Prefab is not part of this submission, it is not mentioned in the Indications for Use of the predicate device.
The minor differences in language of the subject device and the predicate device (in regard to DD Ti-Base 2CUT noLock) also include the compatible implant systems and, therefore, do not affect the intended use. An additional difference is that the DD Ti-Base 2CUT abutments, for the 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 centrallateral incisors only. This language is included in the Indications for Use to support substantial equivalence of the Dentsply Implants Astra Tech OsseoSpeed, Dentsply Implants Xive, Straumann Bone Level, Zimmer Dental Tapered Screw-Vent compatibility as related to the performance bench provided in this submission. Since these series were not part of the predicate device submission in regard to DD Ti-Base 2CUT / DD Ti-Base 2CUT noLock this additional information was not included in the Indications for Use of the predicate device.
In regard to the compatible implant systems, only the Altatech Camlog Screw-Line series is also part of the predicate device in regard to DD Ti-Base 2CUT / DD Ti-Base 2CUT noLock. However, all subject series are also included in the predicate device submission in regard to the one-piece abutment DD Prefab.
The product uses the same fundamental scientific technology compared to the predicate device, as it uses the same materials and same manufacturing technology.
The scientific methods to evaluate the technological characteristics can be therefore as acceptable and the respective data demonstrate that the product is substantially equivalent to the predicate device.
§ 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.)