K Number
K230218
Device Name
DD Solid Connect® CAD/CAM Abutments (further DD Ti-Base 2CUT series)
Manufacturer
Date Cleared
2023-04-25

(89 days)

Product Code
Regulation Number
872.3630
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended 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 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)
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 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).
More Information

K191111 Dental Direkt GmbH - DD Solid Connect® CAD/CAM Abutments

Not Found

No
The summary describes a CAD/CAM system for designing and manufacturing dental abutments. While it uses digital design and manufacturing, there is no mention of AI or ML being used in the design process, analysis, or any other function of the device. The performance studies focus on mechanical and biological testing, not AI/ML performance metrics.

No
The device, DD Solid Connect® CAD/CAM Abutments, supports prosthetic restorations in combination with dental implants, rather than directly treating a disease or condition.

No

This device, DD Solid Connect® CAD/CAM Abutments, is used to support prosthetic restorations in combination with endosseous dental implants. It is a restorative component, not a diagnostic tool used to identify or characterize a disease or condition.

No

The device description clearly states that the device consists of physical components (DD Ti-Base 2CUT and DD Ti-Base 2CUT noLock) made from titanium alloy, which are then combined with a CAD-CAM zirconia superstructure. This indicates a physical medical device, not a software-only one.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use clearly states that the device is used to "support prosthetic restorations in combination with endosseous dental implants in the upper and/or lower jaw." This describes a device used in vivo (within the body) for structural support, not for testing samples in vitro (outside the body) to diagnose a condition.
  • Device Description: The description details the physical components of the abutments and how they attach to dental implants. This aligns with a medical device used for treatment or restoration, not for diagnostic testing.
  • Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's health status.

The device is a dental abutment, which is a type of medical device used in dentistry.

N/A

Intended Use / 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 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)

Product codes (comma separated list FDA assigned to the subject device)

NHA

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 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).

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

upper and/or lower jaw

Indicated Patient Age Range

Not Found

Intended User / Care Setting

knowledgeable and trained dental personnel

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K191111 Dental Direkt GmbH - DD Solid Connect® CAD/CAM Abutments

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

§ 872.3630 Endosseous dental implant abutment.

(a)
Identification. An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)

0

Image /page/0/Picture/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)

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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:
ParameterSpecification
Abutment Post Height4 mm - 6.5 mm
Margin height0.5 mm - 6 mm
Diameter2.9 mm - 5 mm
Wall thickness0.5 mm minimum
Angle from axis of implant0° - 20°

7

Comparison with Predicate Device

FeatureSubject DevicePredicate DeviceComment
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)K191111N/A
Product CodeNHANHAIdentical
Regulatory ClassClass IIClass IIIdentical
Regulation Number872.3630872.3630Identical
Regulation NameEndosseous dental implant abutmentEndosseous dental implant abutmentIdentical
Trade Name 1DD Ti-Base 2CUTDD Ti-Base 2CUTIdentical
Trade Name 2DD Ti-Base 2CUT noLockDD Ti-Base 2CUT noLockIdentical
Trade Name 3N/ADD PrefabN/A (not part of this
submission)
ManufacturerDental Direkt GmbHDental Direkt GmbHIdentical
Intended UseDD 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 useDD 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 CamlogIdentical with respect to:
CAD/CAM
Use with dental implants
Endosseous
Maxillary or mandibular
(upper or lower jaw)
Prosthetic restaurations
FeatureSubject DevicePredicate DeviceComment
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
noLockDD Ti-Base 2CUT /
DD Ti-Base 2CUT
noLockDD Prefab
- Altatech Camlog
Screw-Line3.3, 3.8, 4.3, 5.03.3, 3.8, 4.3, 5.03.3, 3.8, 4.3, 5.0Identical
- Nobel Biocare
Nobel Active3.5 NP, 4.3/5.0 RPN/A3.5 NP, 4.3/5.0 RPIdentical
- Nobel Biocare
Replace Select
Tapered3.5, 4.3, 5.0N/A3.5, 4.3, 5.0Identical
- Straumann Bone
Level3.3, 4.1/4.8N/A3.3, 4.1/4.8Identical
FeatureSubject DevicePredicate DeviceComment
(Equivalence with Predicate Device)
- Straumann
SynOcta4.8, 6.54.8, 6.5Identical
DD Solid Connect ® CAD/CAM Abutments
(further DD Ti-Base 2CUT series)N/A
DD Ti-Base 2CUT / DD Ti-Base 2CUT noLockDD Ti-Base 2CUT / DD Ti-Base 2CUT noLock
DD Prefab
- Zimmer Dental
Tapered Screw-Vent3.5, 4.5, 5.73.5, 4.5, 5.7Identical
- Dentsply Implants
Xive3.4, 3.8, 4.5, 5.53.4, 3.8, 4.5, 5.5Identical
- Dentsply Implants
Astra Tech
OsseoSpeed3.5/4.0, 4.5/5.03.5/4.0, 4.5/5.0Identical
- Zimmer Biomet 3i
Certain3.4, 4.1/5.03.4, 4.1/5.0Identical
- Dentsply Implants
Astra EV3.6, 4.2, 4.8, 5.43.6, 4.2, 4.8, 5.4Identical
Implant to Abutment
Connection / InterfacePrecision implant / abutment interface corresponding to the implant system for which it is usedPrecision implant / abutment interface corresponding to the implant system for which it is usedIdentical
Design parameters DD Ti-Base 2CUT / DD Ti-Base 2CUT noLock
General parameters
- Abutment typeTwo-piece abutmentTwo-piece abutmentIdentical
- Prosthesis
AttachmentCement-retained, Screw-retainedCement-retained, Screw-retainedIdentical
- Restoration TypesSingle-unit, Multi-unitSingle-unit, Multi-unitIdentical
FeatureSubject DevicePredicate DeviceComment
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 axis0° - 20°0° - 20°Identical
- Retention area34 mm²34 mm²Identical
Parameters for the design of the zirconia top half
- Prosthetic Post
Height4 mm - 6,5 mm4 mm - 6,5 mmIdentical
- Gingival Height0,5 mm - 6 mm0,5 mm - 6 mmIdentical
- Diameter2,7 mm - 7 mm2,7 mm - 7 mmIdentical
- Wall ThicknessMin. 0,5 mmMin. 0,5 mmIdentical
Material
One-piece abutmentN/AN/AN/A (not part of this
submission)
Two-piece abutment
(lower part)Ti-6Al-4V ELITi-6Al-4V ELIIdentical
Two-piece abutment
(upper part)Zirconia, ISO 13356Zirconia, ISO 13356Identical
Screw (fixation)Ti-6Al-4V ELITi-6Al-4V ELIIdentical
SterilityProvided Non-sterileProvided Non-sterileIdentical

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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

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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.