(1356 days)
No
The summary describes CAD/CAM technology for manufacturing dental abutments, which is a digital design and manufacturing process, but does not mention or imply the use of AI or ML for design, analysis, or any other function.
Yes
The device is described as "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," which falls under the definition of a therapeutic device designed to support medical interventions.
No
Explanation: The device, DD Solid Connect® CAD/CAM Abutments, is described as supporting prosthetic restorations in combination with dental implants. Its function is to hold dental prosthetics, which is a restorative rather than a diagnostic purpose. The description focuses on its design, compatibility with various implants, and materials, with no mention of diagnosing conditions.
No
The device description clearly outlines physical components (DD Prefab, DD Ti-Base 2CUT, DD Ti-Base 2CUT noLock, implant screw) made of materials like titanium alloy, and mentions manufacturing processes like metal-cutting and milling. Performance studies also include fatigue testing, biocompatibility testing, and sterilization validation, which are relevant to physical devices, not software. While CAD/CAM technology is mentioned for design and production, the device itself is the physical abutment.
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 dental implants in the upper and/or lower jaw. This is a surgical/dental device used directly on a patient's body.
- Device Description: The description details the physical components of the abutments and how they attach to dental implants. This further confirms its role as a physical implant component.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used outside the body to analyze biological samples. This device is used inside the body as a structural component for dental prosthetics.
N/A
Intended Use / Indications for Use
DD Solid Connect® CAD/CAM Abutments are used to support prosthetic restorations in combination with endosseous dental implants in the upper and/or lower jaw.
All digitally designed custom abutments for use with DD Solid Connect® CAD/CAM Abutments are to be sent to a Dental Direkt validated milling center for manufacture.
DD Prefab abutments, for the Zimmer Biomet 3i Certain 3.4mm implant bodies, and DD Ti-Base 2CUT abutments, for the Altatech Camlog Screw-Line 3.3mm implant bodies, are indicated for maxillary lateral and mandibular central/lateral incisors only.
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 |
Product codes
NHA
Device Description
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).
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.
Biocompatibilty testing for cytotoxicity according to ISO 10993-5 [FDA Recognition #2-245].
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]
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)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 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.
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 Quality Center for Devices and Radiological Health
Enclosure
2
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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3
Date: January 11, 2023
| 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 | January 11, 2023 | |
| Trade Name of Device | DD Solid Connect® CAD/CAM Abutments | |
| Common Name | Dental Abutment System | |
| Classification Name | Endosseous dental implant abutment | |
| Regulation Number | 21 CFR 872.3630 | |
| Product Code | NHA | |
| Panel | Dental | |
| Classification | Class 2 | |
| Primary Predicate Device | K180564 Medentika Abutment System, Medentika | |
| CAD/CAM Abutments, Medentika CAD/CAM | ||
| TiBases | ||
| Reference Devices | K202909 Creodent Prosthetics Ltd. - CreoDent Solidex® | |
| Customized Abutment | ||
| K191222 Prismatik Dentalcraft, Inc. - Inclusive® Tita- | ||
| nium Abutments | ||
| Indications for Use | DD Solid Connect® CAD/CAM Abutments are used to | |
| support prosthetic restorations in combination with en- | ||
| dosseous 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 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 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 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 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 super-
structure, 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 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 FDA
Staff Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous
Dental Abutments dated May 12, 2004.
Biocompatibilty testing for cytotoxicity according to ISO
10993-5 [FDA Recognition #2-245].
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]
Reverse engineering dimensional analysis was con-
ducted using OEM implant bodies, OEM abutments, and
OEM abutment screws. | |
| Material | DD Prefab, DD Ti-Base 2CUT (lower part), DD Ti-Base
2CUT 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 | |
| Technological
Characteristics | The DD Solid Connect ® CAD/CAM Abutments are a den-
tal 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 replacements, cardio-
vascular devices and surgical instruments. | |
4
January 11, 2023
Date:
5
Date: January 11, 2023
6
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:
7
Date: January 11, 2023
| Parameter | Specification |
|---|---|
| Abutment Post Height | 4 mm - 6.5 mm |
| Margin height | 0.5 mm - 6 mm |
| Diameter | 2.9 mm - 5 mm |
| Wall thickness | 0.5 mm minimum |
| Angle from axis of implant | 0° - 20° |
| Use in MR Environment | Non-clinical MR review was performed to evaluate the |
| metallic devices in the MR environment using scientific | |
| rationale and published literature (e.g., Woods, Terry O., | |
| Jana G. Delfino, and Sunder Rajan. "Assessment of | |
| Magnetically Induced Displacement Force and Torque | |
| on Metal Alloys Used in Medical Devices." Journal of | |
| Testing and Evaluation 49.2 (2019): 783-795), based on | |
| the subject device components and material composi- | |
| tion. Rationale addressed parameters per the FDA guid- | |
| ance "Testing and Labeling Medical Devices for Safety in | |
| the Magnetic Resonance (MR) Environment". |
8
Comparison with Predicate Device / Reference Devices
| Feature | Subject Device
DD Solid Connect® | Predicate Device
Medentika Abutment
System, Medentika
CAD/CAM Abutments,
Medentika CAD/CAM Ti-
Bases
K180564 | Comment
(Equivalence with
Predicate Device) | Reference Device
CreoDent Solidex
Customized Abutment
K202909 | Reference Device
Inclusive® Titanium
Abutments
K191222 |
|----------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) | K191111 | K180564 | N/A | K202909 | K191222 |
| Product Code | NHA | NHA | Identical | NHA | NHA |
| Regulatory
Class | Class II | Class II | Identical | Class II | Class II |
| Regulation Num-
ber | 872.3630 | 872.3630 | Identical | 872.3630 | 872.3630 |
| Regulation
Name | Endosseous dental im-
plant abutment | Endosseous dental im-
plant abutment | Identical | Endosseous Dental
Implant Abutment, | Endosseous Dental
Implant Abutment, |
| Trade Name 1 | DD Prefab | Medentika Preface | N/A | CreoDent Solidex®
Customized Abut-
ment | Inclusive® Titanium
Abutments |
| 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 Abutments
are intended for auto-
mated CAD/CAM fabri-
cation of individual
dental abutments.
They are available for
various implant sys-
tems as they have the
corresponding prefab-
ricated implant inter-
faces. | Titanium base,
CAD/CAM Blank to be
machined provide to
the patient a custom
designed abutment for
the prosthetic restora-
tion | Similar | Titanium base,
CAD/CAM Blank to
be machined pro-
vide to the patient a
custom designed
abutment for the
prosthetic restora-
tion | Titanium base,
CAD/CAM Blank to
be machined provide
to the patient a cus-
tom designed abut-
ment for the pros-
thetic restoration |
| Indications for
use | DD Solid Connect®
CAD/CAM Abutments
are used to support
prosthetic restorations | Medentika Preface
CAD/CAM Abutments
are intended for use
with dental implants as | Similar with re-
spect to:
- CAD/CAM | The CreoDent
Solidex® Custom-
ized Abutment and
Screw is intended | Inclusive® Titanium
Abutments are pre-
manufactured pros-
thetic components |
| Feature | Subject Device
DD Solid Connect® | Predicate Device
Medentika Abutment
System, Medentika
CAD/CAM Abutments,
Medentika CAD/CAM Ti-
Bases
K180564 | Comment
(Equivalence with
Predicate Device) | Reference Device
CreoDent Solidex
Customized Abutment
K202909 | Reference Device
Inclusive® Titanium
Abutments
K191222 |
| | in combination with en-
dosseous dental im-
plants in the upper
and/or lower jaw.
DD Prefab abutments,
for the Zimmer Biomet
3i Certain 3.4mm im-
plant bodies, and DD
Ti-Base 2CUT abut-
ments, for the Al-
tatech Camlog Screw-
Line 3.3mm implant
bodies, are indicated
for maxillary lateral
and mandibular cen-
tral/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. | a support for single or
multiple tooth prosthe-
ses in the maxilla or
mandible of a partially
for fully endentulous pa-
tient.
Medentika Preface is
intended for use with
the Straumann
CARES system. All
digitally designed abut-
ments for use with
Medentika CAD/CAM
Abutments are in-
tended to be manufac-
tured at a Straumann
Cares validated milling
center.
Medentika TiBase
CAD/CAM Abutments
are intended for use
with dental implants as
a support for single or
multiple tooth prosthe-
ses in the maxilla or
mandible of a partially | Use with dental
implants
Endosseous
Maxillary or
mandibular (up-
per or lower
jaw)
Prosthetic res-
taurations | for use with an en-
dosseous implant to
support a prosthetic
device in patents
who are partially or
completely edentu-
lous. The device
can 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 abutment
screw is used to se-
cure the abutment
to the endosseous
implant. The Solidex
Abutment is com-
patible with the fol-
lowing dental im-
plants: (...)
All digitally designed
tiles for Creodont
Solides Customized
Abutments are to be
sent back to a Creo-
dont validated man- | connected to endos-
seous dental im-
plants in the edentu-
lous or partially
edentulous maxilla
or mandible to pro-
vide support for ce-
ment-retained or
screw-retained pros-
thetic restorations.
All digitally designed
abutments for use
with Inclusive Tita-
nium Abutments for
CAD/CAM are in-
tended to be sent to
a Prismatik Den-
talcraft validated
milling center for
manufacture. Com-
patible Implant Sys-
tem: Dentsply Im-
plants Astra Tech
Implant System®
EV. |
| | | for fully endentulous pa-
tient.
Table
Medentika TiBase is
intended for use with | | ufacturing facility for
manufacture. | |
| Feature | Subject Device
DD Solid Connect® | Predicate Device
Medentika Abutment
System, Medentika
CAD/CAM Abutments,
Medentika CAD/CAM Ti-
Bases
K180564 | Comment
(Equivalence with
Predicate Device) | Reference Device
CreoDent Solidex
Customized Abutment
K202909 | Reference Device
Inclusive® Titanium
Abutments
K191222 |
| | | the Straumann
CARES system. All
digitally designed abut-
ments for use with
Medentika CAD/CAM
Abutments are in-
tended to be manufac-
tured at a Straumann
Cares validated milling
center. | | | |
| Compatible Im-
plant Systems
(implant diameter
in mm) | The DD Solid Con-
nect® CAD/CAM Abut-
ments are compatible
to the following 10 im-
plant systems currently
marketed: | Medentika CAD/CAM
Abutments are com-
patible with 11 dental
implant systems: | N/A | Compatibility is
claimed with the fol-
lowing implant sys-
tems: | Compatibility is
claimed 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 Biocare
Nobel 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 Biocare
Replace Select
Tapered | 3.5, 4.3, 5.0 | 3.5, 4.3, 5.0, 6.0
(Nobel Biocare Re-
place™ Select) | Identical | N/A | N/A |
| - Straumann
Bone Level | 3.3, 4.1/4.8 | 3.3, 4.1, 4.8 | Identical | 3.3, 4.1/4.8 | N/A |
| - Straumann
SynOcta | 4.8, 6.5 | 3.5 (NNC), 4.8, 6.5
(Straumann Standard
N-Series) | Identical | N/A | N/A |
| Feature | Subject Device
DD Solid Connect® | Predicate Device
Medentika Abutment
System, Medentika
CAD/CAM Abutments,
Medentika CAD/CAM Ti-
Bases
K180564 | Comment
(Equivalence with
Predicate Device) | Reference Device
CreoDent Solidex
Customized Abutment
K202909 | Reference Device
Inclusive® Titanium
Abutments
K191222 |
| - Zimmer Dental
Tapered 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 Astra
Tech Osse-
oSpeed | 3.5/4.0, 4.5/5.0 | 3.5, 4.0, 4.5, 5.0 | Identical | N/A | N/A |
| - Zimmer Biomet
3i 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 Implants
Astra EV 3.6, 4.2,
4.8, 5.4 |
| Implant to Abut-
ment Connec-
tion / 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 | 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 |
| 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 (Minimum
not stated) | Identical (Refer-
ence Device 2) | 1 mm - 5 mm | 0,5 mm - 6 mm |
| - Diameter | 3,3 mm - 12 mm | Max. 13 mm (Minimum
not 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 Device
DD Solid Connect® | Predicate Device
Medentika Abutment
System, Medentika
CAD/CAM Abutments,
Medentika CAD/CAM Ti-
Bases
K180564 | Comment
(Equivalence with
Predicate Device) | Reference Device
CreoDent Solidex
Customized Abutment
K202909 | Reference Device
Inclusive® Titanium
Abutments
K191222 |
| - 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 |
| - Restoration
Types | Single-unit, Multi-unit | Single-unit, Multi-unit | Identical | Single-unit, Multi-
unit | Single-unit, Multi-unit |
| DD Ti-Base
2CUT / 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 |
| - Restoration
Types | Single-unit, Multi-unit | Single-unit, Multi-unit | Identical | N/A | Single-unit, Multi-unit |
| - Angulation cor-
rection to the
implant axis | 0° - 20° | 0° - 21° | Similar | N/A | Straight |
| - Retention area | 34 mm² | 34 mm² | Identical | N/A | N/A |
| - Prosthetic Post
Height | 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 (Minimum
not stated) | Identical (Refer-
ence Device 2) | N/A | 0,5 mm - 6 mm |
| - Diameter | 2,7 mm - 7 mm | Max. 10 mm (Minimum
not 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 Device
DD Solid Connect® | Predicate Device
Medentika Abutment
System, Medentika
CAD/CAM Abutments,
Medentika CAD/CAM Ti-
Bases
K180564 | Comment
(Equivalence with
Predicate Device) | Reference Device
CreoDent Solidex
Customized Abutment
K202909 | Reference Device
Inclusive® Titanium
Abutments
K191222 |
| 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 (upper
part) | 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
9
10
11
12
13
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.