(89 days)
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: | |||
Parameter | Specification | ||
Abutment Post Height | 4 mm - 6.5 mm | ||
Margin height | 0.5 mm - 6 mm | ||
Diameter | 2.9 mm - 5 mm | ||
Wall thickness | 0.5 mm minimum | ||
Angle from axis of implant | 0° - 20° |
7
Comparison with Predicate Device
Feature | Subject Device | Predicate Device | Comment | |
---|---|---|---|---|
DD Solid Connect® CAD/CAM Abutments | ||||
(further DD Ti-Base 2CUT series) | DD Solid Connect® CAD/CAM Abutments | (Equivalence with Predicate | ||
Device) | ||||
510(k) | This submission (K230218) | K191111 | N/A | |
Product Code | NHA | NHA | Identical | |
Regulatory Class | Class II | Class II | Identical | |
Regulation Number | 872.3630 | 872.3630 | Identical | |
Regulation Name | Endosseous dental implant abutment | Endosseous dental implant abutment | Identical | |
Trade Name 1 | DD Ti-Base 2CUT | DD Ti-Base 2CUT | Identical | |
Trade Name 2 | DD Ti-Base 2CUT noLock | DD Ti-Base 2CUT noLock | Identical | |
Trade Name 3 | N/A | DD Prefab | N/A (not part of this | |
submission) | ||||
Manufacturer | Dental Direkt GmbH | Dental Direkt GmbH | Identical | |
Intended Use | DD Solid Connect®CAD/CAM Abutments | |||
(further DD Ti-Base 2CUT series) are | ||||
intended for automated CAD/CAM fabrication | ||||
of individual dental abutments. They are | ||||
available for various implant systems as they | ||||
have the corresponding prefabricated implant | ||||
interfaces. | DD Solid Connect® CAD/CAM Abutments are | |||
intended for automated CAD/CAM fabrication | ||||
of individual dental abutments. They are | ||||
available for various implant systems as they | ||||
have the corresponding prefabricated implant | ||||
interfaces. | Identical | |||
Indications for use | DD Solid Connect® CAD/CAM Abutments | |||
(further DD Ti-Base 2CUT series) are used to | ||||
support prosthetic restorations in combination | ||||
with endosseous dental implants in the upper | ||||
and/or lower jaw. | ||||
DD Ti-Base 2CUT abutments, for the Altatech | ||||
Camlog Screw-Line 3.3mm implant bodies, | DD Solid Connect® CAD/CAM Abutments are | |||
used to support prosthetic restorations in | ||||
combination with endosseous dental implants | ||||
in the upper and/or lower jaw. | ||||
DD Prefab abutments, for the Zimmer Biomet 3i | ||||
Certain 3.4mm implant bodies, and DD Ti-Base | ||||
2CUT abutments, for the Altatech Camlog | Identical with respect to: | |||
CAD/CAM | ||||
Use with dental implants | ||||
Endosseous | ||||
Maxillary or mandibular | ||||
(upper or lower jaw) | ||||
Prosthetic restaurations | ||||
Feature | Subject Device | Predicate Device | Comment | |
DD Solid Connect® CAD/CAM Abutments | ||||
(further DD Ti-Base 2CUT series) | DD Solid Connect® CAD/CAM Abutments | (Equivalence with Predicate | ||
Device) | ||||
Dentsply Implants Astra Tech OsseoSpeed | ||||
3.5mm implant bodies, Dentsply Implants Xive | ||||
3.4mm implant bodies, Straumann Bone Level | ||||
3.3mm implant bodies, Zimmer Biomet 3i | ||||
Certain 3.4mm implant bodies and Zimmer | ||||
Dental Tapered Screw-Vent 3.5mm implant | ||||
bodies are indicated for maxillary lateral and | ||||
mandibular central/lateral incisors only. | Screw-Line 3.3mm implant bodies, are | |||
indicated for maxillary lateral and mandibular | ||||
central/lateral incisors only. | ||||
All digitally designed custom abutments for use | ||||
with DD Solid Connect® CAD/CAM Abutments | ||||
are to be sent to a Dental Direkt validated | ||||
milling center for manufacture. | ||||
All digitally designed custom abutments for | ||||
use with DD Solid Connect® CAD/CAM | ||||
Abutments (further DD Ti-Base 2CUT series) | ||||
are to be sent to a Dental Direkt validated | ||||
milling center for manufacture. | ||||
Compatible Implant Systems | ||||
(implant diameter in mm) | ||||
DD Ti-Base 2CUT / DD Ti-Base 2CUT | ||||
noLock | DD Ti-Base 2CUT / | |||
DD Ti-Base 2CUT | ||||
noLock | DD Prefab | |||
- Altatech Camlog | ||||
Screw-Line | 3.3, 3.8, 4.3, 5.0 | 3.3, 3.8, 4.3, 5.0 | 3.3, 3.8, 4.3, 5.0 | Identical |
- Nobel Biocare | ||||
Nobel Active | 3.5 NP, 4.3/5.0 RP | N/A | 3.5 NP, 4.3/5.0 RP | Identical |
- Nobel Biocare | ||||
Replace Select | ||||
Tapered | 3.5, 4.3, 5.0 | N/A | 3.5, 4.3, 5.0 | Identical |
- Straumann Bone | ||||
Level | 3.3, 4.1/4.8 | N/A | 3.3, 4.1/4.8 | Identical |
Feature | Subject Device | Predicate Device | Comment | |
(Equivalence with Predicate Device) | ||||
- Straumann | ||||
SynOcta | 4.8, 6.5 | 4.8, 6.5 | Identical | |
DD Solid Connect ® CAD/CAM Abutments | ||||
(further DD Ti-Base 2CUT series) | N/A | |||
DD Ti-Base 2CUT / DD Ti-Base 2CUT noLock | DD Ti-Base 2CUT / DD Ti-Base 2CUT noLock | |||
DD Prefab | ||||
- Zimmer Dental | ||||
Tapered Screw-Vent | 3.5, 4.5, 5.7 | 3.5, 4.5, 5.7 | Identical | |
- Dentsply Implants | ||||
Xive | 3.4, 3.8, 4.5, 5.5 | 3.4, 3.8, 4.5, 5.5 | Identical | |
- Dentsply Implants | ||||
Astra Tech | ||||
OsseoSpeed | 3.5/4.0, 4.5/5.0 | 3.5/4.0, 4.5/5.0 | Identical | |
- Zimmer Biomet 3i | ||||
Certain | 3.4, 4.1/5.0 | 3.4, 4.1/5.0 | Identical | |
- Dentsply Implants | ||||
Astra EV | 3.6, 4.2, 4.8, 5.4 | 3.6, 4.2, 4.8, 5.4 | Identical | |
Implant to Abutment | ||||
Connection / Interface | Precision implant / abutment interface corresponding to the implant system for which it is used | Precision implant / abutment interface corresponding to the implant system for which it is used | Identical | |
Design parameters DD Ti-Base 2CUT / DD Ti-Base 2CUT noLock | ||||
General parameters | ||||
- Abutment type | Two-piece abutment | Two-piece abutment | Identical | |
- Prosthesis | ||||
Attachment | Cement-retained, Screw-retained | Cement-retained, Screw-retained | Identical | |
- Restoration Types | Single-unit, Multi-unit | Single-unit, Multi-unit | Identical | |
Feature | Subject Device | Predicate Device | Comment | |
DD Solid Connect® CAD/CAM Abutments | ||||
(further DD Ti-Base 2CUT series) | DD Solid Connect® CAD/CAM Abutments | (Equivalence with Predicate | ||
Device) | ||||
- Angulation | ||||
correction to the | ||||
implant axis | 0° - 20° | 0° - 20° | Identical | |
- Retention area | 34 mm² | 34 mm² | Identical | |
Parameters for the design of the zirconia top half | ||||
- Prosthetic Post | ||||
Height | 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 this | |
submission) | ||||
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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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.