(121 days)
No
The device description focuses on mechanical components, CAD/CAM processes for customization, and compatibility with existing systems. There is no mention of AI or ML in the intended use, device description, or performance studies.
Yes.
The device is intended to restore chewing function in edentulous or partially edentulous patients, which is a therapeutic purpose.
No
The device is described as prosthetic components (abutments and suprastructures) intended to provide support for bridges or overdentures and restore chewing function in edentulous or partially edentulous patients. Its purpose is mechanical support and restoration, not diagnosis.
No
The device description clearly details physical components (abutments, suprastructures, screws) and mentions manufacturing processes (CAD/CAM) for physical devices. While CAD is software, the final product is a physical medical device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the devices are for providing support for bridges or overdentures and restoring chewing function. This is a mechanical/structural function within the body.
- Device Description: The description details physical components like abutments, suprastructures, and screws used for dental restoration.
- No mention of in vitro testing: The text does not describe any testing of samples (like blood, urine, tissue) outside of the body to diagnose a condition or provide information about a physiological state.
- Performance Studies: The performance studies focus on mechanical properties (fatigue testing), sterilization, packaging, and geometric compatibility, which are relevant to a medical device used for structural support, not an IVD.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Multibase Abutments EV are intended to be used in conjunction with Astra Tech Implant System EV in fully edentulous or partially edentulous maxillary and/or mandibular arches to provide support for bridges or overdentures.
ATLANTISTM Suprastructures are indicated for attachment to dental implants or abutments in the treatment of partially or totally edentulous jaws for the purpose of restoring chewing function.
ATLANTISTM Suprastructures are intended for attachment to a minimum of two (2) implants and are indicated for compatibility with the following implant and abutment systems:
Implants:
Biomet 3i - Certain (3.25, 4/3 – Prevail 3/4/3, 4/3; 4.0, 5/4 – Prevail 4/5/4. 5/4; 5.0, XP 4/5 – Prevail 5/6/5, 6/5; 6.0, XP 5/6)
BioHorizons - Internal/Tapered (3.5, 4.5, 5.7)
Camlog - Screw-line Implant (3.3)
Camlog - Screw-line / Root-line Implant (3.8, 4.3, 5.0, 6.0)
DENTSPLY Implants - XiVE (S 3.0, S 3.4, S 3.8, S 4.5, S 5.5)
DENTSPLY Implants - OsseoSpeed™ TX (3.0, 3.5/4.0, 4.5/5.0)
DENTSPLY Implants - OsseoSpeed™ Profile TX (4.5/5.0)
DENTSPLY Implants - OsseoSpeed™ EV (3.0, 3.6, 4.2, 4.8, 5.4)
DENTSPLY Implants - OsseoSpeed™ Profile EV (4.2, 4.8)
Keystone Dental - PrimaConnex (SD 3.3/3.5; RD 4.0/4.1; WD 5.0)
Keystone Dental - Genesis (3.8, 4.5, 5.5/6.5)
Nobel Biocare - NobelActive (NP 3.5 – RP 4.3, 5.0)
Nobel Biocare - NobelReplace (NP-3.5 – RP 4.3 – WP 5.0 – 6.0)
Straumann - Bone Level (3.3 NC – 4.1, 4.8 NC)
Straumann - Standard Plus (3.5 NN)
Straumann - Standard / Standard Plus (4.8 RN – 4.8 WN)
Zimmer Dental - Tapered Screw Vent/Screw Vent (Tapered S-V 3.5/S-V 3.3, 3.7/ Tapered S-V 4.5/ S-V 4.5; 5.7)
Abutments:
Biomet 3i - Low Profile Abutment
DENTSPLY - ATIS Uni Abutment EV
DENTSPLY - ATIS UniAbutment 20°, ATIS UniAbutment 45°
DENTSPLY - ATIS Angled Abutment EV
DENTSPLY - ATIS Angled Abutment 20°
DENTSPLY - ANKYLOS Balance Base Narrow D4.2, Balance Base D5.5
DENTSPLY - ATIS Multibase Abutment EV
DENTSPLY - XiVE MP 3.4, MP 3.8, MP 4.5, MP 5.5
DENTSPLY - XiVE TG 3.4, TG 3.8, TG 4.5
Nobel Biocare - Multi-Unit Abutment RP
Straumann - Bone Level Multi-Base Angled Abutment
Straumann - Bone Level Multi-Base Abutment D3.5, D4.5
Straumann - RN Abutment Level, WN Abutment Level
Straumann - Screw-Retained Abutment 3.5, 4.6
Zimmer Dental - Tapered Abutment
Product codes (comma separated list FDA assigned to the subject device)
NHA
Device Description
The subject of this bundled 510(k) consists of the proposed Multibase Abutments EV with accompanying accessories and the corresponding ATLANTIS™ Suprastructures, which are currently marketed under premarket notification K160207 and are proposed for modification under this submission to include compatibility with the proposed Multibase Abutments EV. The proposed devices are intended to be used by dental clinicians for prosthetic restoration in the maxilla and mandible.
The subject Multibase Abutments EV are additional components for the existing OsseoSpeed™ EV implants (cleared in K120414 under the name OsseoSpeed™ Plus) and the OsseoSpeed™ Profile EV implants (K130999). The subject Multibase Abutments EV are designed for multi-unit, screw-retained restorations in a partially or fully edentulous situation. They are provided in three platform diameters (3.6. 4.2 and 4.8 mm) and available as straight version and in two angles (17° and 30°). The straight abutments are one-piece abutments and provided in three gingival heights (1.5, 2.5 and 3.5 mm). They have a nonindexed interface. All abutments with a 17° or 30° angle represent two-piece abutments and are available in two gingival heights (1.5 and 2.5 mm) with an indexed or non-indexed interface. The two-piece, angled variants of the Multibase Abutment EV devices consist of the abutment body and a screw channel cap which is threaded to the abutment body to cover the abutment body's connection screw channel. The screw channel cap features internal threads to facilitate connection of screw-retained restorations. The subject Multibase Abutment EV devices are also designed for compatibility with the temporary prosthetic cylinder and bridge screw components of the reference predicate NobelActive Multi-Unit Abutment system (K072570).
The ATLANTIS™M Suprastructures are patient-specific restorative devices that are intended to be attached to dental implants or abutments to facilitate prosthetic restoration in the treatment of partially and totally edentulous patients. The design of the proposed device is derived from patient dental models and completed by Dentsply Sirona technicians using computer-assisted design (CAD) according to the clinician's prescription. The final CAD design of the ATLANTISTM Suprastructures are fabricated using computer-assisted manufacturing (CAM) to produce a customized, patient-specific device. The proposed abutment-interface of the ATLANTIS™ Suprastructures, compatible with the proposed Multibase Abutments EV. are available in the same design types as cleared for the predicate ATLANTISTM ISUS Implant Suprastructures in K160207:
- Bar Intended as a fixed supporting structure for a removable dental prosthesis.
- Bridge Intended for direct veneering using dental ceramics or resin composites resulting in a fixed, screw-retained prosthesis.
- Hybrid Intended as a fixed denture framework.
- 2 in 1 Intended as a fixed supporting structure for a removable dental prosthesis in combination with a hybrid denture framework retained by friction fit. The primary structure is a non-standard bar configuration. The secondary structure is a bridge or hybrid denture restoration with a tapered friction fit connection rather than a screwretained connection.
Screws are available for all compatible implant and abutments systems to attach the ATLANTISTM Suprastructures to the implant or onto the abutment.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
maxillary and/or mandibular arches, jaws
Indicated Patient Age Range
Not Found
Intended User / Care Setting
dental clinicians
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)
Non-clinical testing data submitted, referenced, or relied upon to demonstrate substantial equivalence includes:
- Sterilization: Sterilization validation of the sterile, straight variants of the subject Multibase Abutments EV is referenced by equivalence to sterilization validation of existing worst-case challenge validations conducted according to ISO 11137-1 and ISO 11137-2 which conclude that a sterility assurance level (SAL) of 10-6 is achieved under the sterilization process parameters utilized. Sterilization validation of the angled variants of the subject Multibase Abutments EV was conducted to validate an SAL of 10-6 according to ISO 11137-1 and ISO 11137-2 and the results are summarized in this premarket notification.
- Moist heat sterilization parameters of non-sterile components included with the subject Multibase Abutments EV were validated by equivalence to sterilization validation of existing worst-case challenge validations conducted according to ISO 17665-1 and ISO17665-2 demonstrating a sterility assurance level (SAL) of 10-9.
- Packaging and shelf life validation according to ISO 11607 and ASTM F1980 were conducted and the results are referenced to support substantial equivalence.
- Fatigue Testing: Dynamic fatigue testing conducted on the worst case construct of the subject Multibase Abutments EV devices according to ISO 14801 is included to support substantial equivalence.
- Geometric measurement data and statistical compatibility analysis is included to support the compatibility of the subject Multibase Abutments EV devices with the temporary prosthetic cylinder and bridge screw components of the reference predicate system (K072570).
- Cross-sectional material analysis of the ATLANTIS™ Suprastructures interface with the subject Multibase Abutments EV devices is included and compared to existing worst case interface geometry to support substantial equivalence.
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.
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.
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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol of three human profiles facing right, arranged in a cascading manner, representing the department's focus on people and health.
Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 31, 2017
Dentsply Sirona Karl Nittinger Senior Manager, Corporate Regulatory Affairs 221 West Philadelphia Street Suite 60 York, Pennsylvania 17404
Re: K163350
Trade/Device Name: Multibase Abutments EV and ATLANTIS Suprastructures Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: February 24, 2017 Received: February 27, 2017
Dear Karl Nittinger:
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. 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.
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 (reporting of medical device
1
Page 2 - Karl Nittinger
related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address:
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely.
Michael J. Ryan -S
for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
2
Indications for Use
510(k) Number (if known)
Device Name
Multibase Abutments EV
Indications for Use (Describe)
The Multibase Abutments EV are intended to be used in conjunction with Astra Tech Implant System EV in fully edentulous or partially edentulous maxillary and/or mandibular arches to provide support for bridges or overdentures.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
� Prescription Use (Part 21 CFR 801 Subpart D)
- Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known)
Device Name
ATLANTIS™ Suprastructures
Indications for Use (Describe)
ATLANTIS™ Suprastructures are indicated for attachment to dental implants or abutments in the treatment of partially or totally edentulous jaws for the purpose of restoring chewing function.
ATLANTIS™ Suprastructures are intended for attachment to a minimum of two (2) implants and are indicated for compatibility with the following implant and abutment systems:
| Manufacturer | Name of Implant | Size |
|---|---|---|
| Biomet 3i | Certain | 3.25, 4/3 – Prevail 3/4/3, 4/3 |
| Certain | 4.0, 5/4 – Prevail 4/5/4. 5/4 | |
| Certain | 5.0, XP 4/5 – Prevail 5/6/5, 6/5 | |
| Certain | 6.0, XP 5/6 | |
| BioHorizons | Internal/Tapered | 3.5, 4.5, 5.7 |
| Camlog | Screw-line Implant | 3.3 |
| Screw-line / Root-line Implant | 3.8, 4.3, 5.0, 6.0 | |
| DENTSPLY Implants | XiVE | S 3.0, S 3.4, S 3.8, S 4.5, S 5.5 |
| OsseoSpeed™ TX | 3.0, 3.5/4.0, 4.5/5.0 | |
| Osseospeed™ Profile TX | 4.5/5.0 | |
| Osseospeed™ EV | 3.0, 3.6, 4.2, 4.8, 5.4 | |
| Osseospeed™ Profile EV | 4.2, 4.8 | |
| Keystone Dental | PrimaConnex | SD 3.3/3.5 |
| PrimaConnex | RD 4.0/4.1 | |
| PrimaConnex | WD 5.0 | |
| Genesis | 3.8, 4.5, 5.5/6.5 | |
| Nobel Biocare | NobelActive | NP 3.5 – RP 4.3, 5.0 |
| NobelReplace | NP-3.5 – RP 4.3 – WP 5.0 – 6.0 | |
| Straumann | Bone Level | 3.3 NC – 4.1, 4.8 NC |
| Standard Plus | 3.5 NN | |
| Standard / Standard Plus | 4.8 RN – 4.8 WN | |
| Zimmer Dental | Tapered Screw Vent/ | |
| Screw Vent | Tapered S-V 3.5/S-V 3.3, 3.7 | |
| /Tapered S-V 4.5/ S-V 4.5 | ||
| Tapered Screw Vent | 5.7 |
4
| Abutments: | |
|---|---|
| Manufacturer | Name of Abutment |
| Biomet 3i | Low Profile Abutment |
| DENTSPLY | ATIS Uni Abutment EV |
| DENTSPLY | ATIS UniAbutment 20°, ATIS UniAbutment 45° |
| DENTSPLY | ATIS Angled Abutment EV |
| DENTSPLY | ATIS Angled Abutment 20° |
| DENTSPLY | ANKYLOS Balance Base Narrow D4.2, Balance Base D5.5 |
| DENTSPLY | ATIS Multibase Abutment EV |
| DENTSPLY | XiVE MP 3.4, MP 3.8, MP 4.5, MP 5.5 |
| DENTSPLY | XiVE TG 3.4, TG 3.8, TG 4.5 |
| Nobel Biocare | Multi-Unit Abutment RP |
| Straumann | Bone Level Multi-Base Angled Abutment |
| Straumann | Bone Level Multi-Base Abutment D3.5, D4.5 |
| Straumann | RN Abutment Level, WN Abutment Level |
| Straumann | Screw-Retained Abutment 3.5, 4.6 |
| Zimmer Dental | Tapered Abutment |
Type of Use (Select one or both, as applicable)
ا Prescription Use (Part 21 CFR 801 Subpart D)
— Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
FORM FDA 3881 (8/14)
Page 1 of 1
PSC Publishing Services (301) 443-6740 FF
5
Dentsply Sirona 221 West Philadelphia Street Suite 60 York, PA 17404
Image /page/5/Picture/1 description: The image shows the Dentsply Sirona logo. The logo consists of a stylized, abstract shape on the left, resembling a curved or folded form. To the right of the shape are the words "Dentsply" and "Sirona" stacked vertically, with "Dentsply" on top of "Sirona". The text is in a simple, sans-serif font.
SECTION 5. 510(k) SUMMARY
for
Multibase Abutments EV and ATLANTIS™ Suprastructures
-
- Submitter Information:
Dentsply Sirona 221 West Philadelphia Street Suite 60 York, PA 17404
- Submitter Information:
| Contact Person: | Karl Nittinger |
|---|---|
| Telephone Number: | 717-849-4424 |
| Fax Number: | 717-849-4343 |
Date Prepared: 30 March 2017
-
- Device Name:
- Multibase Abutments EV and ATLANTIS™ ● Proprietary Name:
- Suprastructures Classification Name: Endosseous dental implant abutment
- 21 CFR 872.3630
- Suprastructures Classification Name: Endosseous dental implant abutment
- . CFR Number: Class II
- Device Class: ●
- Product Code: NHA ●
Predicate Device: 3.
.
The predicate devices for the Multibase Abutments EV and ATLANTISTM Suprastructures, subject to this bundled 510(k) submission, are as follows:
| Predicate Device Name | 510(k) | Company Name |
|---|---|---|
| OsseoSpeed™ Angled Abutment EV | ||
| (Primary Predicate Device) | K121810 | Dentsply Sirona |
| (formerly ASTRA TECH) | ||
| NobelActive Multi Unit Abutment | ||
| (Reference Predicate Device) | K072570 | Nobel Biocare |
| OsseoSpeed™ Plus | ||
| (Reference Predicate Device) | K120414 | Dentsply Sirona |
| (formerly Astra Tech AB) | ||
| OsseoSpeed™ Profile EV | ||
| (Reference Predicate Device) | K130999 | Dentsply Sirona |
Predicate devices for the proposed Multibase Abutments EV:
Predicate device for the modifications relating to the proposed compatibility of the ATLANTIS™ Suprastructures with the proposed Multibase Abutments EV:
| Predicate Device Name | 510(k) | Company Name |
|---|---|---|
| ATLANTIS™ ISUS Implant Suprastructures | ||
| (Primary Predicate Device) | K160207 | Dentsply Sirona |
6
4. Description of Device:
The subject of this bundled 510(k) consists of the proposed Multibase Abutments EV with accompanying accessories and the corresponding ATLANTIS™ Suprastructures, which are currently marketed under premarket notification K160207 and are proposed for modification under this submission to include compatibility with the proposed Multibase Abutments EV. The proposed devices are intended to be used by dental clinicians for prosthetic restoration in the maxilla and mandible.
The subject Multibase Abutments EV are additional components for the existing OsseoSpeed™ EV implants (cleared in K120414 under the name OsseoSpeed™ Plus) and the OsseoSpeed™ Profile EV implants (K130999). The subject Multibase Abutments EV are designed for multi-unit, screw-retained restorations in a partially or fully edentulous situation. They are provided in three platform diameters (3.6. 4.2 and 4.8 mm) and available as straight version and in two angles (17° and 30°). The straight abutments are one-piece abutments and provided in three gingival heights (1.5, 2.5 and 3.5 mm). They have a nonindexed interface. All abutments with a 17° or 30° angle represent two-piece abutments and are available in two gingival heights (1.5 and 2.5 mm) with an indexed or non-indexed interface. The two-piece, angled variants of the Multibase Abutment EV devices consist of the abutment body and a screw channel cap which is threaded to the abutment body to cover the abutment body's connection screw channel. The screw channel cap features internal threads to facilitate connection of screw-retained restorations. The subject Multibase Abutment EV devices are also designed for compatibility with the temporary prosthetic cylinder and bridge screw components of the reference predicate NobelActive Multi-Unit Abutment system (K072570).
The ATLANTIS™M Suprastructures are patient-specific restorative devices that are intended to be attached to dental implants or abutments to facilitate prosthetic restoration in the treatment of partially and totally edentulous patients. The design of the proposed device is derived from patient dental models and completed by Dentsply Sirona technicians using computer-assisted design (CAD) according to the clinician's prescription. The final CAD design of the ATLANTISTM Suprastructures are fabricated using computer-assisted manufacturing (CAM) to produce a customized, patient-specific device. The proposed abutment-interface of the ATLANTIS™ Suprastructures, compatible with the proposed Multibase Abutments EV. are available in the same design types as cleared for the predicate ATLANTISTM ISUS Implant Suprastructures in K160207:
-
- Bar Intended as a fixed supporting structure for a removable dental prosthesis.
-
- Bridge Intended for direct veneering using dental ceramics or resin composites resulting in a fixed, screw-retained prosthesis.
-
- Hybrid Intended as a fixed denture framework.
-
- 2 in 1 Intended as a fixed supporting structure for a removable dental prosthesis in combination with a hybrid denture framework retained by friction fit. The primary structure is a non-standard bar configuration. The secondary structure is a bridge or hybrid denture restoration with a tapered friction fit connection rather than a screwretained connection.
Screws are available for all compatible implant and abutments systems to attach the ATLANTISTM Suprastructures to the implant or onto the abutment.
7
న. Indications for Use:
Multibase Abutments EV
The Multibase Abutments EV are intended to be used in conjunction with Astra Tech Implant System EV in fully edentulous or partially edentulous maxillary and/or mandibular arches to provide support for bridges or overdentures.
ATLANTIS™ Suprastructures
ATLANTISTM Suprastructures are indicated for attachment to dental implants or abutments in the treatment of partially or totally edentulous jaws for the purpose of restoring chewing function.
ATLANTISTM Suprastructures are intended for attachment to a minimum of two (2) implants and are indicated for compatibility with the following implant and abutment systems:
| Manufacturer | Name of Implant | Size |
|---|---|---|
| Biomet 3i | Certain | 3.25, 4/3 – Prevail 3/4/3, 4/3 |
| Certain | 4.0, 5/4 – Prevail 4/5/4. 5/4 | |
| Certain | 5.0, XP 4/5 – Prevail 5/6/5, 6/5 | |
| Certain | 6.0, XP 5/6 | |
| BioHorizons | Internal/Tapered | 3.5, 4.5, 5.7 |
| Camlog | Screw-line Implant | 3.3 |
| Screw-line / Root-line Implant | 3.8, 4.3, 5.0, 6.0 | |
| DENTSPLY Implants | XiVE | S 3.0, S 3.4, S 3.8, S 4.5, S 5.5 |
| OsseoSpeed™ TX | 3.0, 3.5/4.0, 4.5/5.0 | |
| OsseoSpeed™ Profile TX | 4.5/5.0 | |
| OsseoSpeed™ EV | 3.0, 3.6, 4.2, 4.8, 5.4 | |
| OsseoSpeed™ Profile EV | 4.2, 4.8 | |
| Keystone Dental | PrimaConnex | SD 3.3/3.5 |
| PrimaConnex | RD 4.0/4.1 | |
| PrimaConnex | WD 5.0 | |
| Genesis | 3.8, 4.5, 5.5/6.5 | |
| Nobel Biocare | NobelActive | NP 3.5 – RP 4.3, 5.0 |
| NobelReplace | NP-3.5 – RP 4.3 – WP 5.0 – 6.0 | |
| Straumann | Bone Level | 3.3 NC – 4.1, 4.8 NC |
| Standard Plus | 3.5 NN | |
| Standard / Standard Plus | 4.8 RN – 4.8 WN | |
| Zimmer Dental | Tapered Screw Vent/ | |
| Screw Vent | Tapered S-V 3.5/S-V 3.3, 3.7 | |
| /Tapered S-V 4.5/ S-V 4.5 | ||
| Tapered Screw Vent | 5.7 |
Implants:
8
Abutments:
| Manufacturer | Name of Abutment |
|---|---|
| Biomet 3i | Low Profile Abutment |
| DENTSPLY | ATIS Uni Abutment EV |
| ATIS UniAbutment 20°, ATIS UniAbutment 45° | |
| ATIS Angled Abutment EV | |
| ATIS Angled Abutment 20° | |
| ANKYLOS Balance Base Narrow D4.2, Balance Base D5.5 | |
| ATIS Multibase Abutment EV | |
| XiVE MP 3.4, MP 3.8, MP 4.5, MP 5.5 | |
| XiVE TG 3.4, TG 3.8, TG 4.5 | |
| Nobel Biocare | Multi-Unit Abutment RP |
| Straumann | Bone Level Multi-Base Angled Abutment |
| Bone Level Multi-Base Abutment D3.5, D4.5 | |
| RN Abutment Level, WN Abutment Level | |
| Screw-Retained Abutment 3.5, 4.6 | |
| Zimmer Dental | Tapered Abutment |
-
- Substantial Equivalence:
Technological Characteristics
An overview of the similarities and differences between the subject and predicate devices is given in Table 1/ Table 3: Indications for Use for the proposed and the predicate Abutments/ Suprastructures and in Table 2/ Table 4: Similarities and Differences between the proposed and the predicate Abutments/ Suprastructures
Biocompatibility
The material used for the Multibase Abutments EV and the ATLANTISTM Suprastructures, including the corresponding screws, and the manufacturing process remained unchanged compared to the corresponding primary predicate devices, OsseoSpeed™ Angled Abutment EV (K121810) and ATLANTIS™ ISUS Implant Suprastructures (K160207). Therefore, no additional biocompatibility testing has been performed.
7. Non-Clinical Performance Data
Non-clinical testing data submitted, referenced, or relied upon to demonstrate substantial equivalence includes:
- Sterilization: Sterilization validation of the sterile, straight variants of the subject ● Multibase Abutments EV is referenced by equivalence to sterilization validation of existing worst-case challenge validations conducted according to ISO 11137-1 and ISO 11137-2 which conclude that a sterility assurance level (SAL) of 106 is achieved under the sterilization process parameters utilized. Sterilization validation of the angled variants of the subject Multibase Abutments EV was conducted to validate an SAL of 10- according to ISO 11137-1 and ISO 11137-2 and the results are summarized in this premarket notification.
- . Moist heat sterilization parameters of non-sterile components included with the subject Multibase Abutments EV were validated by equivalence to sterilization validation of existing worst-case challenge validations conducted according to ISO 17665-1 and ISO17665-2 demonstrating a sterility assurance level (SAL) of 10-9.
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- Packaging and shelf life validation according to ISO 11607 and ASTM F1980 were ● conducted and the results are referenced to support substantial equivalence.
- Fatigue Testing: Dynamic fatigue testing conducted on the worst case construct of ● the subject Multibase Abutments EV devices according to ISO 14801 is included to support substantial equivalence.
- Geometric measurement data and statistical compatibility analysis is included to support the compatibility of the subject Multibase Abutments EV devices with the temporary prosthetic cylinder and bridge screw components of the reference predicate system (K072570).
- . Cross-sectional material analysis of the ATLANTIS™ Suprastructures interface with the subject Multibase Abutments EV devices is included and compared to existing worst case interface geometry to support substantial equivalence.
8. Conclusion Regarding Substantial Equivalence
The proposed Multibase Abutments EV and the proposed abutment-interface of the ATLANTISTM Suprastructures, subject of this bundled 510(k), are endosseous dental implant abutments which are intended to be used by dental clinicians for prosthetic restoration in the maxilla and mandible. The proposed Multibase Abutments EV and the proposed corresponding ATLANTISTM Suprastructures have the same intended use, incorporates the same fundamental technology, and have similar indications for use as the predicate devices for the Multibase Abutments EV (K121810, K072750, K120414, K130999) and the predicate device for the ATLANTIS™ Suprastructures (K160207), respectively.
Thus, it can be concluded that the proposed Multibase Abutments EV and ATLANTISTM Suprastructures are substantially equivalent to the predicate devices.
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| Proposed Device | Primary Predicate Device | Reference Predicate Device |
|---|---|---|
| Dentsply Sirona | ||
| Multibase Abutments EV | Dentsply Sirona | |
| OsseoSpeed™ Angled Abutment EV | ||
| K121810 | Nobel Biocare | |
| NobelActive Multi Unit Abutment | ||
| K072570 | ||
| The Multibase Abutments EV are | ||
| intended to be used in conjunction | ||
| with Astra Tech Implant System | ||
| EV in fully edentulous or partially | ||
| edentulous maxillary and/or | ||
| mandibular arches to provide | ||
| support for bridges or | ||
| overdentures. | OsseoSpeed™ Angled Abutment EV is | |
| intended to be used in conjunction with | ||
| Astra Tech implant System EV in fully | ||
| edentulous or partially edentulous | ||
| maxillary and/or mandibular arches to | ||
| provide support for bridges or | ||
| overdentures. | ||
| The Atlantis™ Abutment is intended for use | ||
| with an endosseous implant to support a | ||
| prosthetic device in a partially or completely | ||
| edentulous patient. It is intended for use to | ||
| support single and multiple tooth prostheses, | ||
| in the mandible or maxilla. The prosthesis can | ||
| be cemented, screw retained or friction fit to | ||
| the abutment. The abutment screw is intended | ||
| to secure the abutment to the endosseous | ||
| implant. | ||
| The Atlantis™ Crown Abutment in Zirconia is | ||
| intended for use with an endosseous implant | ||
| to function as a substructure that also serves | ||
| as the final restoration, in partially or | ||
| completely edentulous patients. The prosthesis | ||
| is screw retained. The abutment screw is | ||
| intended to secure the crown abutment to the | ||
| endosseous implant. | ||
| Atlantis™ Abutment and Atlantis™ Crown | ||
| Abutment are compatible with Ø5.4 Astra | ||
| Tech Implant System EV | NobelActive Multi Unit Abutment is a pre- | |
| manufactured prosthetic component directly | ||
| connected to the endosseous dental implant | ||
| and is intended for use as an aid prosthetic | ||
| rehabilitation. |
The indications for use of the subject Multibase Abutments EV devices are identical to the cleared indications for use of the primary predicate Osseospeed™ Angled Abutment EV devices cleared in premarket notification K121810. Also cleared in K121810 with the primary predicate Osseospeed™ Angled Abutment EV were the Atlantis™ Abutment and the Atlantis™ Crown Abutment in Zirconia. The Atlantis™ Abutment and Atlantis™ Crown Abutment in Zirconia were cleared in K121810 with indications for use which are independent from the cleared indications for use of the primary predicate Osseospeed™ Angled Abutment EV (K121810) as shown in Table 1 above. Comparison to the Atlantis™ Abutment and Atlantis™ Crown Abutment in Zirconia was not included to support the substantial equivalence of the subject Multibase Abutments EV devices.
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| Proposed Device | Primary Predicate Device | Reference Predicate Device | |
|---|---|---|---|
| Dentsply Sirona | |||
| Multibase Abutments EV | Dentsply Sirona | ||
| OsseoSpeedTM | |||
| Angled Abutment EV | |||
| K121810 | Nobel Biocare | ||
| NobelActive | |||
| Multi Unit Abutment | |||
| K072570 | |||
| Design | |||
| Prosthesis Attachment | Screw-retained | Screw-retained | Screw-retained |
| Restoration | Multi-unit | Multi-unit | Multi-unit |
| Abutment design | One-piece (0°), | ||
| Two-piece (17°, 30°) | One-piece | One-piece | |
| Abutment Angulation | 0°, 17°, 30° | 20°, 30° | 0°, 17°, 30° |
| Gingiva Height | 1.5, 2.5, 3.5 mm | 1.0, 2.0, 3.0 mm | 1.5, 2.5, 3.5, 4.5 mm |
| Interface abutment- | |||
| implant | Internal | Internal | Internal |
| Material | |||
| Abutment | Ti-6Al-4V | Ti-6Al-4V | Ti6Al4V |
| Screw | Ti-6Al-4V | Ti-6Al-4V | Ti6Al4V |
| Delivery | sterile | sterile | sterile |
Table 2: Similarities and Differences between the proposed and the predicate Abutments
The "two-piece" abutment design of the subject angled Multibase Abutments EV devices refers to the threaded superior cap which facilitates the closure of the abutment body's attachment screw channel. When the cap is assembled to the subject angled Multibase Abutments EV abutment body, the superior portion of the abutment device is geometrically identical to that of the one-piece "straight" (0°) abutment design.
Dynamic fatigue testing conducted according to ISO 14801 and referenced in Section 7 of this 510(k) Summary was conducted on the worst case (angled) construct of the subject Multibase Abutments EV devices, which included the two-piece assembly with attached screw channel cap as described above. The results of the dynamic fatigue testing conducted according to ISO 14801 and included in this premarket notification support the substantial equivalence of the subject Multibase Abutments EV.
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| Table 3: Indications for Use for the proposed and the predicate Suprastructures | |||
|---|---|---|---|
| Proposed Device | Predicate Device | ||||
|---|---|---|---|---|---|
| Dentsply Sirona | Dentsply Sirona | ||||
| ATLANTIST™ Suprastructures | ATLANTIST™ Implant Suprastructures | ||||
| K160207 | |||||
| ATLANTIST™ Suprastructures are indicated for attachment to dental | ATLANTIST™ Suprastructures are indicated for attachment to dental | ||||
| implants or abutments in the treatment of partially or totally edentulous | implants or abutments in the treatment of partially or totally edentulous | ||||
| jaws for the purpose of restoring chewing function. | jaws for the purpose of restoring chewing function. | ||||
| ATLANTIST™ Suprastructures are intended for attachment to a minimum | ATLANTIST™ Suprastructures are intended for attachment to a minimum | ||||
| of two (2) implants and are indicated for compatibility with the | of two (2) implants and are indicated for compatibility with the following | ||||
| following implant and abutment systems: | implant and abutment systems: | ||||
| Implants: | Implants: | ||||
| Manufacturer | Name of Implant | Size | Manufacturer | Name of Implant | Size |
| Biomet 3i | Certain | 3.25, 4/3 - Prevail 3/4/3, 4/3 | Biomet 3i | Certain | 3.25, 4/3 - Prevail 3/4/3, 4/3 |
| Certain | 4.0, 5/4 - Prevail 4/5/4. 5/4 | Certain | 4.0, 5/4 - Prevail 4/5/4. 5/4 | ||
| Certain | 5.0, XP 4/5 - Prevail 5/6/5, 6/5 | Certain | 5.0, XP 4/5 - Prevail 5/6/5, 6/5 | ||
| Certain | 6.0, XP 5/6 | Certain | 6.0, XP 5/6 | ||
| BioHorizons | Internal/Tapered | 3.5, 4.5, 5.7 | BioHorizons | Internal/Tapered | 3.5, 4.5, 5.7 |
| Camlog | Screw-line Implant | 3.3 | Camlog | Screw-line Implant | 3.3 |
| Screw-line / Root-line | 3.8, 4.3, 5.0, 6.0 | Screw-line / Root-line | 3.8, 4.3, 5.0, 6.0 | ||
| DENTSPLY | |||||
| Implants | XiVE | S 3.0, S 3.4, S 3.8, S 4.5, S 5.5 | DENTSPLY | ||
| Implants | XiVE | S 3.0, S 3.4, S 3.8, S 4.5, S 5.5 | |||
| OsseoSpeed™ TX | 3.0, 3.5/4.0, 4.5/5.0 | OsseoSpeed™ TX | 3.0, 3.5/4.0, 4.5/5.0 | ||
| OsseoSpeed™ Profile TX | 4.5/5.0 | OsseoSpeed™ Profile TX | 4.5/5.0 | ||
| OsseoSpeed™ EV | 3.0, 3.6, 4.2, 4.8, 5.4 | OsseoSpeed™ EV | 3.0, 3.6, 4.2, 4.8, 5.4 | ||
| OsseoSpeed™ Profile EV | 4.2, 4.8 | OsseoSpeed™ Profile EV | 4.2, 4.8 | ||
| Keystone | |||||
| Dental | PrimaConnex | SD 3.3/3.5 | Keystone | ||
| Dental | PrimaConnex | SD 3.3/3.5 | |||
| PrimaConnex | RD 4.0/4.1 | PrimaConnex | RD 4.0/4.1 | ||
| PrimaConnex | WD 5.0 | PrimaConnex | WD 5.0 | ||
| Genesis | 3.8, 4.5, 5.5/6.5 | Genesis | 3.8, 4.5, 5.5/6.5 | ||
| Nobel Biocare | NobelActive | NP 3.5 - RP 4.3, 5.0 | Nobel Biocare | NobelActive | NP 3.5 - RP 4.3, 5.0 |
| NobelReplace | NP-3.5 - RP 4.3 - WP 5.0 - | NobelReplace | NP-3.5 - RP 4.3 - WP 5.0 - | ||
| Straumann | Bone Level | 3.3 NC - 4.1, 4.8 NC | Straumann | Bone Level | 3.3 NC - 4.1, 4.8 NC |
| Standard Plus | 3.5 NN | Standard Plus | 3.5 NN | ||
| Standard / Standard Plus | 4.8 RN - 4.8 WN | Standard / Standard Plus | 4.8 RN - 4.8 WN | ||
| Zimmer Dental | |||||
| Screw Vent | Tapered Screw Vent / | Tapered S-V 3.5/S-V 3.3, 3.7 / | |||
| Tapered S-V 4.5/ S-V 4.5 | Zimmer Dental | ||||
| Screw Vent | Tapered Screw Vent | Tapered S-V 3.5/S-V 3.3, 3.7 / | |||
| S-V 4.5/ S-V 4.5 | |||||
| Tapered Screw Vent | 5.7 | Tapered Screw Vent | 5.7 | ||
| Abutments: | Abutments: | ||||
| Manufacturer | Name of Abutment | Manufacturer | Name of Abutment | ||
| Biomet 3i | Low Profile Abutment | Biomet 3i | Low Profile Abutment | ||
| DENTSPLY | ATIS Uni Abutment EV | DENTSPLY | ATIS Uni Abutment EV | ||
| ATIS UniAbutment 20°, ATIS UniAbutment 45° | ATIS UniAbutment 20°, ATIS UniAbutment 45° | ||||
| ATIS Angled Abutment EV | ATIS Angled Abutment EV | ||||
| ATIS Angled Abutment 20° | ATIS Angled Abutment 20° | ||||
| ANKYLOS Balance Base Narrow D4.2, Balance | ANKYLOS Balance Base Narrow D4.2, Balance | ||||
| ATIS Multibase Abutment EV | XiVE MP 3.4, MP 3.8, MP 4.5, MP 5.5 | ||||
| XiVE MP 3.4, MP 3.8, MP 4.5, MP 5.5 | XiVE TG 3.4, TG 3.8, TG 4.5 | ||||
| XiVE TG 3.4, TG 3.8, TG 4.5 | |||||
| Nobel Biocare | Multi-Unit Abutment RP | Nobel Biocare | Multi-Unit Abutment RP | ||
| Straumann | Bone Level Multi-Base Angled Abutment | Straumann | Bone Level Multi-Base Angled Abutment | ||
| Bone Level Multi-Base Abutment D3.5, D4.5 | |||||
| RN Abutment Level, WN Abutment Level | |||||
| Screw-Retained Abutment 3.5, 4.6 | Bone Level Multi-Base Abutment D3.5, D4.5 | ||||
| RN Abutment Level, WN Abutment Level | |||||
| Screw-Retained Abutment 3.5, 4.6 | |||||
| Zimmer Dental | Tapered Abutment | Zimmer Dental | Tapered Abutment |
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As shown in Table 3, the modification to the indications for use of the ATLANTISTM Suprastructures which is subject to this premarket notification consists of the addition of the Astra Tech Implant System (ATIS) Multibase Abutment EV device to the list of compatible abutments. There are no other changes to the indications for use of the ATLANTIS™ Suprastructures as compared to the indications for use cleared previously under premarket notification K160207.
In order to support the substantial equivalence of the addition of compatibility with the Multibase Abutment EV devices to the indications for use of the ATLANTIS™ Suprastructures, geometric analysis of the abutment interface was included. The results of the analysis showed that the interface which facilitates compatibility with the Multibase Abutment EV devices does not present a new worst case with respect to cross-sectional material geometry and the modification therefore does not affect the substantial equivalence of the ATLANTISTM Suprastructures.
| Proposed Device | Predicate Device | |
|---|---|---|
| Dentsply Sirona | ||
| ATLANTIS™ Suprastructures | Dentsply Sirona | |
| ATLANTIS™ ISUS Implant | ||
| Suprastructures | ||
| K160207 | ||
| Design | ||
| Prosthesis Attachment | Screw-retained, Friction-fit | Screw-retained, Friction-fit |
| Design of Suprastructure | Bar, | |
| Bridge | ||
| Hybrid | ||
| 2 in 1 | Bar, | |
| Bridge | ||
| Hybrid | ||
| 2 in 1 | ||
| Platform diameter | 3.0-6.5 | 3.0-6.5 |
| Interface suprastructure- | ||
| implant/ abutment | Internal, External | Internal, External |
| Material | ||
| Suprastructure | CPTi, CoCr | CPTi, CoCr |
| Screw | Ti-6Al-4V ELI | Ti-6Al-4V ELI |
| Delivery | sterile | sterile |
Table 4: Similarities and Differences between the proposed and the predicate Suprastructures