(237 days)
No
The device description focuses on CAD/CAM design and fabrication based on clinician prescriptions and patient models, with no mention of AI or ML for design or analysis.
Yes
The device is described as a "patient-specific restorative device" used "for the purpose of restoring chewing function" in patients with partially or totally edentulous jaws, which implies treating a condition and restoring function.
No
This device is a patient-specific restorative device intended to restore chewing function, not to diagnose a condition.
No
The device description explicitly states that the final CAD design is fabricated using computer-assisted manufacturing (CAM) to produce a customized, patient-specific device, which is a physical object (implant suprastructure). The performance studies also involve mechanical testing of these physical devices.
Based on the provided text, the ATLANTIS™ ISUS Implant Suprastructures are not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to restore chewing function by attaching to dental implants or abutments in the treatment of partially or totally edentulous jaws. This is a direct therapeutic and restorative function within the body.
- Device Description: The device is described as a "patient-specific restorative device" that is "attached to dental implants or abutments to facilitate prosthetic restoration." This further emphasizes its role in restoring physical function.
- Lack of Diagnostic Purpose: There is no mention of the device being used to examine specimens derived from the human body for the purpose of providing information for diagnosis, monitoring, or compatibility testing.
IVD devices are typically used to perform tests on samples like blood, urine, or tissue outside of the body to diagnose or monitor medical conditions. The ATLANTIS™ ISUS Implant Suprastructures are implanted devices used for physical restoration.
N/A
Intended Use / Indications for Use
ATLANTIS™ ISUS Implant 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™ ISUS Implant 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
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 S-V 3.5/S-V 3.3, 3.7 / S-V 4.5/ S-V 4.5
Tapered Screw Vent 5.7
Abutments:
Biomet 3i Low Profile Abutment
DENTSPLY Implants ATIS Uni Abutment EV
DENTSPLY Implants ATIS UniAbutment 20°, ATIS UniAbutment 45°
DENTSPLY Implants ATIS Angled Abutment EV
DENTSPLY Implants ATIS Angled Abutment 20°
DENTSPLY Implants ANKYLOS Balance Base Narrow D4.2, Balance Base D5.5
DENTSPLY Implants XiVE MP 3.4, MP 3.8, MP 4.5, MP 5.5
DENTSPLY Implants 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 ATLANTIS™ ISUS Implant Suprastructures include new implant and abutment interfaces of the predicate ISUS Implant Suprastructures, cleared in K122424.
The ATLANTIS™ ISUS Implant 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 subject device is derived from patient dental models and completed by DENTSPLY technicians using computer-assisted design (CAD) according to the clinician's prescription. The final CAD design of the ATLANTIS™ ISUS suprastructures are fabricated using computer-assisted manufacturing (CAM) to produce a customized, patient-specific device.
The subject ATLANTIS™ ISUS Implant Suprastructures are available in the same design types as cleared for the predicate ISUS Implant Suprastructures in K122424:
- 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.
Screws are available for all compatible implant and abutments systems to screw the ATLANTIS™ ISUS Implant Suprastructures into the implant or onto the abutment.
In addition to the introduction of the new interfaces of the ATLANTIS™ ISUS Implant Suprastructures, the product reference names of the compatible interfaces are adjusted in the indications for use for the currently marketed ATLANTIS™ ISUS Implant Suprastructures to better reflect the original manufacturer's product description.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
partially or totally edentulous jaws
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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: mechanical design analysis, dimensional analysis and static and dynamic compression-bending testing according to ISO 14801 Dentistry -- Implants -- Dynamic fatigue test for endosseous dental implants. The new interfaces of the ATLANTIS™ ISUS Implant Suprastructures are determined to have sufficient strength for their intended use. Compatibility analysis shows that the subject ATLANTIS™ ISUS Implant Suprastructures are compatible with the predicate implant and abutment systems.
The material used for the ATLANTIS™ ISUS Implant Suprastructures, including the corresponding screws, and the manufacturing process remained unchanged compared to the predicate device, ISUS Implant Suprastructures (K122424). The results of biocompatibility testing conducted for the primary predicate device, ISUS Implant Suprastructures (K122424), are therefore valid and no additional biocompatibility testing has been performed.
No clinical performance data were submitted.
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.
K121810, K931767, K101732, K120414, K080156, K130999, K071638, K000099, K000100, K051614, K101545, K133421
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 features a stylized caduceus symbol, which is often associated with healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 21, 2016
DENTSPLY International, Inc. Helen Lewis Director, Corporate Regulatory Affairs 221 West Philadelphia St., Suite 60 York, Pennsylvania 17401
Re: K160207
Trade/Device Name: ATLANTIS™ ISUS Implant Suprastructures Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous dental implant abutment Regulatory Class: Class II Product Code: NHA Dated: August 19, 2016 Received: August 22, 2016
Dear Helen Lewis,
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
1
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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 yours,
Michael D/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
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name
ATLANTIS ISUS™ Implant Suprastructures
Indications for Use (Describe)
ATLANTIS™ ISUS Implant 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™ ISUS Implant 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:
| 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 | S-V 3.5/S-V 3.3, 3.7 / S-V 4.5/ S-V 4.5 |
| Tapered Screw Vent | 5.7 |
3
| Manufacturer | Name of Abutment |
|---|---|
| Biomet 3i | Low Profile Abutment |
| DENTSPLY Implants | ATIS Uni Abutment EV |
| DENTSPLY Implants | ATIS UniAbutment 20°, ATIS UniAbutment 45° |
| DENTSPLY Implants | ATIS Angled Abutment EV |
| DENTSPLY Implants | ATIS Angled Abutment 20° |
| DENTSPLY Implants | ANKYLOS Balance Base Narrow D4.2, Balance Base D5.5 |
| DENTSPLY Implants | XiVE MP 3.4, MP 3.8, MP 4.5, MP 5.5 |
| DENTSPLY Implants | 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)
|X 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 OMBnumber."
4
SECTION 5. 510(k) SUMMARY
for ATLANTIS™ ISUS Implant Suprastructures
1. Submitter Information:
DENTSPLY International Susquehanna Commerce Center 221 West Philadelphia Street, Suite 60W York, PA 17401
| Contact Person: | Helen Lewis |
|---|---|
| Telephone Number: | 717-487-1332 |
| Fax Number: | 717-849-4343 |
Date Prepared: September 20, 2016
2. Device Name:
- . Proprietary Name:
- Classification Name: .
- CFR Number: .
- . Device Class:
- Product Code: . NHA
3. Predicate Device:
The subject device is substantially equivalent in indications and design principles to the following legally marketed predicate devices:
Class II
21 CFR 872.3630
ATLANTIS™ ISUS Implant Suprastructures
Endosseous dental implant abutment
Primary Predicate Device:
| Predicate Device Name | 510(k) | Company Name |
|---|---|---|
| ISUS Implant Suprastructures | K122424 | DENTSPLY International, Inc. |
Reference Predicate Devices:
| Predicate Device Name | 510(k) | Company Name |
|---|---|---|
| Astra Tech OsseoSpeed Angled Abutment EV | K121810 | DENTSPLY International, Inc. |
| (former: ASTRA TECH AB) | ||
| Astra Tech Implants-Dental System | K931767 | DENTSPLY International, Inc. |
| (former: ASTRA TECH AB) | ||
| Astra Tech Implant System | K101732 | DENTSPLY International, Inc. |
| (former: ASTRA TECH AB) | ||
| Astra Tech OsseoSpeed Plus | K120414 | DENTSPLY International, Inc. |
| (former: ASTRA TECH AB) | ||
| Astra Tech OsseoSpeed Profile System | K080156 | DENTSPLY International, Inc. |
| (former: ASTRA TECH AB) | ||
| Astra Tech OsseoSpeed Profile EV | K130999 | DENTSPLY International, Inc. |
| (former: ASTRA TECH AB) | ||
| BioHorizons Tapered Internal Implant System | K071638 | BioHorizons Implant Systems, Inc. |
| Camlog Screw Implant System | K000099 | Altatec Biotechnologies |
5
| Predicate Device Name | 510(k) | Company Name |
|---|---|---|
| Camlog Rootform Implant System | K000100 | Altatec Biotechnologies |
| Lifecore PrimaConnex Internal Connection | ||
| Implant System | K051614 | Keystone Dental, Inc. |
| (former: Lifecore Biomedical, Inc.) | ||
| Genesis Implant System | K101545 | Keystone Dental, Inc. |
| Straumann Magellan Screw-Retained | ||
| Abutment System | K133421 | Institut Straumann AG |
4. Description of Device:
The ATLANTIS™ ISUS Implant Suprastructures include new implant and abutment interfaces of the predicate ISUS Implant Suprastructures, cleared in K122424.
The ATLANTIS™ ISUS Implant 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 subject device is derived from patient dental models and completed by DENTSPLY technicians using computer-assisted design (CAD) according to the clinician's prescription. The final CAD design of the ATLANTIS™ ISUS suprastructures are fabricated using computer-assisted manufacturing (CAM) to produce a customized, patient-specific device.
The subject ATLANTIS™ ISUS Implant Suprastructures are available in the same design types as cleared for the predicate ISUS Implant Suprastructures in K122424:
-
- 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.
Screws are available for all compatible implant and abutments systems to screw the ATLANTIS™ ISUS Implant Suprastructures into the implant or onto the abutment.
In addition to the introduction of the new interfaces of the ATLANTIS™ ISUS Implant Suprastructures, the product reference names of the compatible interfaces are adjusted in the indications for use for the currently marketed ATLANTIS™ ISUS Implant Suprastructures to better reflect the original manufacturer's product description.
6
5. Indications for Use:
ATLANTIS™ ISUS Implant 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™ ISUS Implant 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 | S-V 3.5/S-V 3.3, 3.7 / S-V 4.5/ S-V |
| 4.5 | ||
| Tapered Screw Vent | 5.7 |
Implants:
Abutments:
| Manufacturer | Name of Abutment |
|---|---|
| Biomet 3i | Low Profile Abutment |
| DENTSPLY Implants | ATIS Uni Abutment EV |
| DENTSPLY Implants | ATIS UniAbutment 20°, ATIS UniAbutment 45° |
| DENTSPLY Implants | ATIS Angled Abutment EV |
| DENTSPLY Implants | ATIS Angled Abutment 20° |
| DENTSPLY Implants | ANKYLOS Balance Base Narrow D4.2, Balance Base D5.5 |
| DENTSPLY Implants | XiVE MP 3.4, MP 3.8, MP 4.5, MP 5.5 |
| DENTSPLY Implants | 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 |
ATLANTIS™ ISUS Implant Suprastructures
DENTSPLY International Inc.
7
6. Substantial Equivalence:
Technological Characteristics.
An overview of the similarities and differences between the subject and predicate devices is given in Table 1: Indications for Use for the proposed and the predicate devices and Table 2: Similarities and Differences between the proposed and the predicate devices
Non-Clinical Performance Data.
Non-clinical testing data submitted, referenced, or relied upon to demonstrate substantial equivalence includes: mechanical design analysis, dimensional analysis and static and dynamic compression-bending testing according to ISO 14801 Dentistry -- Implants -- Dynamic fatigue test for endosseous dental implants. The new interfaces of the ATLANTIS™ ISUS Implant Suprastructures are determined to have sufficient strength for their intended use. Compatibility analysis shows that the subject ATLANTIS™ ISUS Implant Suprastructures are compatible with the predicate implant and abutment systems.
The material used for the ATLANTIS™ ISUS Implant Suprastructures, including the corresponding screws, and the manufacturing process remained unchanged compared to the predicate device, ISUS Implant Suprastructures (K122424). The results of biocompatibility testing conducted for the primary predicate device, ISUS Implant Suprastructures (K122424), are therefore valid and no additional biocompatibility testing has been performed.
No clinical performance data were submitted.
Conclusion Regarding Substantial Equivalence
The ATLANTIS™ ISUS Implant 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 ATLANTIS™ ISUS Implant Suprastructures have the same intended use, composed of the same or similar materials and incorporates the same fundamental technology as the predicate devices, K122424, K121810, K931767, K101732, K120414, K080156, K130999, K071638, K000099, K000100, K051614, K101545, K133421.
Thus, it can be concluded that the subject ATLANTIS™ ISUS Implant Suprastructures are substantially equivalent to the predicate devices.
8
Table 1: Indications for Use for the proposed and the predicate devices
| Subject
| Device | Indications for Use |
|---|---|
| DENTSPLY | |
| International, Inc. | ATLANTIS™ ISUS Implant 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 | |
| ISUS Implant | |
| Suprastructures | ATLANTIS™ ISUS Implant Suprastructures are intended for attachment to a minimum of two (2) implants and are indicated for |
| compatibility with the following implant and abutment systems: | |
| K122424 | Implants: |
| Biomet 3i Certain 3.25, 4/3 - Prevail 3/4/3, 4/3 | |
| Biomet 3i Certain 4.0, 5/4 - Prevail 4/5/4, 5/4 | |
| Biomet 3i Certain 5.0,XP4/5 - Prevail 5/6/5, 6/5 | |
| Biomet 3i Certain 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 | |
| Keystone Dental PrimaConnex RD 4.0/4.1 | |
| Keystone Dental PrimaConnex 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 RC | |
| Straumann Standard Plus 3.5 NN | |
| Straumann Standard/Standard Plus 4.8 RN - 4.8 WN | |
| Zimmer Dental Tapered S-V 3.5/ S-V 3.3, 3.7 / S-V 4.5/ S-V 4.5 | |
| Zimmer Dental Tapered Screw-Vent 5.7 | |
| Abutments: | |
| Biomet 3i Low Profile Abutment | |
| DENTSPLY Implants ATIS Uni Abutment EV | |
| DENTSPLY Implants ATIS UniAbutment 20°, ATIS UniAbutment 45° | |
| DENTSPLY Implants ATIS Angled Abutment EV | |
| DENTSPLY Implants ATIS Angled Abutment 20° | |
| DENTSPLY Implants ANKYLOS Balance Base Narrow D4.2, Balance Base D5.5 | |
| DENTSPLY Implants XiVE MP 3.4, MP 3.8, MP 4.5, MP 5.5 | |
| DENTSPLY Implants 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 | |
| DENTSPLY | |
| International, Inc. | The ISUS Implant 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. The ISUS Implant Suprastructures are intended for attachment to a minimum of two (2) implants. |
| ISUS Implant | |
| Suprastructures | ISUS Implant Suprastructures are indicated for compatibility with the following implant and abutment systems: |
| K122424 | Implants: |
- Nobel Biocare Replace Select: NP (3.5mm), RP (4.3mm), WP (5.0mm), and Replace Select 6.0mm
- Nobel Biocare Active Internal: NP (3.5mm), RP (4.3mm, 5.0mm)
*Zimmer Screw Vent: 1D3.5, D4.5, D5.7
*Straumann: NN (3.5mm), RN (4.8mm), WN (6.0mm)
*Straumann Bone Level: NC (3.3mm), RC (4.1 mm, 4.8mm)
*31 Internal Connection: D3.4, D4.1, D5, D6
*Friadent XiVE S: D3, D3.4, D3.8, D4.5, D5.5 |
| | Abutments:
*Astra Tech- 20° and 45° UniAbutment
*Astra Tech UniAbutment EV: 3.6
*ANKYLOS Balance Base Abutment D5.5 and Narrow Abutment D4.2
*Nobel Biocare Multi -Unit Abutment RP: 4.0 mm
*Zimmer Tapered Abutment: 4.5mm |
| | *Straumann RN(4.8mm), WN (6.5 mm)
*Straumann Bone Level: Multi-Base Abutment D3.5, D4.5 |
9
10
| *Straumann Bone Level Angled Abutment:4.0 mm | |
|---|---|
| *31 Low Profile Abutment | |
| *Friadent XiVE MP D3.8, D4.5, D5.5 | |
| *Friadent XiVE TG D3.8, D4.5, D5.5 | |
| DENTSPLY | |
| International, Inc. | OsseoSpeed™ Angled Abutment EV is intended to be used in conjunction with Astra TechImplant System BY in fully edentulous or |
| partially edentulous maxillary and/ar mandibular arches to provide support for bridges or overdentures. | |
| Astra Tech | |
| OsseoSpeed Angled | |
| Abutment EV | 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. | |
| K121810 | The Atlantis™ Crown Abutment in Zircania 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 Atlanis™ Crown Abutment are compatible with 05.4 Astra Tech Implant System EV. | |
| DENTSPLY | |
| International, Inc. | Astra Tech Implant System Angled Abutment 20° is indicated when there is a marked inclination of the fixture in the bucco lingual |
| direction. The use of angled abutment prevents from a situation of penetrating the buccal veneer of the crown when setting the bridge. | |
| Astra Tech Implants- | |
| Dental System | |
| K931767 | |
| DENTSPLY | |
| International, Inc. | The OsseoSpeed™ implants are intended to be used: |
| • to replace missing teeth in single or multiple unit applications within the mandible or maxilla | |
| Astra Tech Implant | |
| System | • for immediate placement in extraction sites and partially or completely healed alveolar ridge situations |
| • for both one- and two-stage surgical procedures | |
| • especially well in soft bone applications where implants with other implant surface treatments may be less effective | |
| K101732 | • together with immediate loading protocol in all indications, except in single tooth situations in soft bone (type IV) where implant stability |
| may be difficult to obtain and immediate loading may not be appropriate | |
| • together with immediate loading protocol for single-tooth restorations on implants 8 mm or longer | |
| • with its 3.0 S product line for maxillary lateral incisors and mandibular lateral and central incisors. | |
| DENTSPLY | |
| International, Inc. | The OsseoSpeed™ EV implants are intended to be used for both one- and two-stage surgical procedures in |
| the following situations and with the following clinical protocols: | |
| • replacing single and multiple missing teeth in the mandible and maxilla, | |
| Astra Tech | |
| OsseoSpeed Plus | • immediate placement in extraction sites and in situations with a partially or completely healed alveolar ridge, |
| • especially indicated for use in soft bone applications where implants with other implant surface treatments may be less effective. | |
| K120414 | • immediate loading in all indications, except in single tooth situations on implants shorter than 8 mm or in soft bone (type IV) where |
| implant stability may be difficult to obtain and immediate loading may not be appropriate. | |
| The intended use for OsseoSpeedTM Plus 3.05 is limited to replacement of maxillary lateral | |
| incisors and mandibular incisors. | |
| DENTSPLY | |
| International, Inc. | |
| Astra Tech | |
| OsseoSpeed Profile | |
| System | |
| K080156 | OsseoSpeed TX Profile is intended to be used to replace missing masticatory functional units (teeth) in single or multiple unit applications |
| within the mandible or maxilla. The device may be used equally well in a single-stage or two-stage surgical procedure. It is indicated for | |
| immediate implantation in extraction sites or implantation in partially healed or completely healed alveolar ridge situations. When a one- | |
| stage surgical approach is applied, the implant may be immediately loaded when good primary stability is achieved and the functional load | |
| is appropriate. | |
| DENTSPLY | |
| International, Inc. | |
| Astra Tech | |
| OsseoSpeed Profile | |
| EV | |
| K130999 | OsseoSpeed Profile EV implants are intended for both one- and two-stage surgical procedures in the following situations and with the |
| following clinical protocols: | |
| • replacing missing teeth in single or multiple unit applications in the mandible or maxilla. | |
| • immediate placement in extraction sites and in situations with a partially or completely healed alveolar ridge | |
| • especially indicated for use in soft bone applications where implants with other implant surface treatments may be less effective | |
| • immediate and early loading for all indications | |
| • together with immediate loading protocol in all indications, except in single tooth situations in soft bone (type IV) where implant stability | |
| may be difficult to obtain and immediate loading may not be appropriate | |
| BioHorizons | |
| Implant | |
| Systems,Inc. |
BioHorizons
Tapered Internal
Implant System
K071638 | The BioHorizons Tapered Internal Implant System is intended for use in the mandible or maxilla for use as an artificial root structure for
single tooth replacement or for fixed bridgework and dental retention.
The BioHorizons Tapered Internal Implant System may be restored immediately
- with a temporary prosthesis that is not in functional occlusion or
- when splinted together for multiple tooth replacement or when stabilized with an overdenture supported by multiple implants. |
| Altatec
Biotechnologies
Camlog Screw
Implant System
K000099 | Camlog Screw-Line Implant is intended for endosseous use in the maxilla and mandible for functional aesthetic rehabilitation in partial or
fully edentulous patients.Immediate and delayed implantation, as well as immediate or delayed loading. |
| Altatec
Biotechnologies
Camlog Rootform
Implant System
K000100 | Camlog Root-Line implants are indicated for single tooth replacement, as immediate abutments on long span to bridge work, as distal
abutments on free-end edentulous areas to be restored with fixed bridgework, to support overdentures in totally or partially edentulous
arches, and as abutments supporting a full arch fixed prosthesis on the totally edentulous mandible or maxilla. |
| Keystone Dental, Inc.
Lifecore
PrimaConnex
Internal Connection
Implant System
K051614 | Lifecore Biomedical Dental Implant System implants are intended for use in partially or fully edentulous mandibles and maxillae, in
support of single or multiple-unit restorations including: cement retained, screw retained, or overdenture restorations, and terminal or
intermediate abutment support for fixed bridgework.
The PrimaConnexr Internal Connection Implant is a threaded implant that is intended for immediate placement and can be restored with a
temporary prosthesis in single tooth and multiple tooth applications with good quality bone.
The PrimaConnex Internal Connection Implant is intended for immediate provisionalization,non-occlusal load. Immediate
Provisionalization is defined by the International Congress of Oral Implantologists (ICOI) as a clinical protocol for the placement of an
interim prosthesis with or without occlusal contact with the opposing dentition, at the same clinical visit of implant placement. The
PrimaConnex Internal Connection Implant can be restored with a temporary prosthesis in single tooth and multiple tooth applications with
good quality bone. |
| Keystone Dental, Inc.
Genesis Implant
System K101545 | The Genesis Implant System is intended for use in single-stage or two-stage surgical procedures in all types of bone in partially or fully
edentulous mandibles and maxillae. The Genesis Implant System supports single or multiple-unit restorations to re-establish patient
chewing function and esthetics. Genesis implants are intended for placement following natural tooth loss or for immediate placement into
an extraction socket. Immediate function may be achieved when good primary stability is established and appropriate occlusal loading
is applied. |
| Institut Straumann
AG
Straumann Magellan
Screw-Retained
Abutment System
K133421 | The Straumann Magellan abutments are indicated to be placed into Straumann dental implants to provide support for prosthetic
reconstructions such as crowns, bridges and bars. The final processed devices have the purpose of restoring chewing function. Magellan
abutments are indicated for screw-retained restorations. |
11
12
13
| | Subject
Device | Predicate Devices | | | | | | | | | | | | | |
|-------------------------------------------------------|----------------------------------------------|------------------------------------|---------------------------------------------------|--------------------------------------------|------------------------------------|------------------------------------|-----------------------------------------------|----------------------------------------|---------------------------------------------------------|--------------------------------------|-----------------------------------------|---------------------------------------------|--------------------------------|-------------------------------------------------------------------|--|
| | DENTSPLY
International, Inc | DENTSPLY
International,
Inc. | DENTSPLY
International,
Inc. | DENTSPLY
International,
Inc. | DENTSPLY
International,
Inc. | DENTSPLY
International,
Inc. | DENTSPLY
International,
Inc. | DENTSPLY
International,
Inc. | BioHorizons
Implant
Systems, Inc. | Altatec
Biotechno-
logies | Altatec
Biotechnolo-
gies | Keystone
Dental, Inc. | Keystone
Dental, Inc. | Institut
Straumann
AG | |
| | Atlantis™ ISUS
Implant
Suprastructures | ISUS Implant
Suprastructures | Astra Tech
OsseoSpeed
Angled
Abutment EV | Astra Tech
Implants
Dental
System | Astra Tech
Implants
System | Astra Tech
OsseoSpeed
Plus | Astra Tech
OsseoSpeed
Profile
System | Astra Tech
OsseoSpeed
Profile EV | BioHorizons
Tapered
Internal
Implant
System | Camlog
Screw
Implant
System | Camlog
Rootform
Implant
System | Keystone Dental
Prima Connex
Implants | Genesis
Implant
System | Straumann
Magellan
Screw-
Retained
Abutment
System | |
| | | K122424 | K121810 | K931767 | K101732 | K120414 | K080156 | K130999 | K071638 | K000099 | K000100 | K051614 | K101545 | K133421 | |
| Design | | | | | | | | | | | | | | | |
| Prosthesis
Attachment | Screw-
retained | Screw-
retained | Screw-
retained | Screw-
retained | Screw &
Cement-
retained | Screw &
Cement-
retained | Screw &
Cement-
retained | Screw &
Cement-
retained | Screw &
Cement-
retained | Screw &
Cement-
retained | Screw &
Cement-
retained | Screw &
Cement-
retained | Screw &
Cement-
retained | Screw-
retained | |
| Restoration | Multi-unit | Multi-unit | Multi-unit | Multi-unit | Single or
Multi-unit | Single or
Multi-unit | Single or
Multi-unit | Single or
Multi-unit | Single or
Multi-unit | Single or
Multi-unit | Single or
Multi-unit | Single or
Multi-unit | Single or
Multi-unit | Single or
Multi-unit | |
| Platform
Diameter | 3.0 - 6.5 | 3.0 - 6.5 | 3.6, 4.2,
4.8,5.4 | 3.5/4.0,
4.5/5.0 | 3.0, 3.5/4.0,
4.5/5.0,
5.0S | 3.0, 3.5,
4.0, 4.5, 5.0 | 4.5/5.0 | 4.2, 4.8 | 3.5, 4.5,
5.7 | 3.3, 3.8,
4.3, 5.0, 6.0 | 3.3, 3.8,
4.3, 5.0, 6.0 | 3.5, 4.1, 5.0 | 3.8,4.5,5.5,
6.5 | 3.5, 4.6 | |
| Connection
suprastructure
-implant/
abutment | Internal,
External | Internal,
External | External | External | Internal | Internal | Internal | Internal | Internal | Internal | Internal | Internal | Internal | External | |
| Material | | | | | | | | | | | | | | | |
| Abutment | CPTi,
CoCr | CPTi,
CoCr, | Ti-6Al-4V
ELI | Ti-6Al-4V
ELI | N/A | N/A | N/A | N/A | N/A | N/A | N/A | Ti-6Al-4V
ELI | Ti-6Al-4V
ELI | Ti-6Al-7Nb | |
| Screw | Ti-6Al-4V
ELI | Ti-6Al-4V
ELI | Ti-6Al-4V
ELI | Ti-6Al-4V
ELI | N/A | N/A | N/A | N/A | N/A | N/A | N/A | Ti-6Al-4V
ELI | Ti-6Al-4V
ELI | Ti-6Al-7Nb | |