(153 days)
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 prosthesis, 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.
This device is compatible with the following manufacturers' implant systems:
The Atlantis Abutment in Zirconia for Dentsply Ankylos Implant is compatible with the Dentsply Ankylos 3.5mm, 4.5mm, 5.5mm and 7.0mm Implants.
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.
This device is compatible with the following manufacturers' implant systems:
the Dentsply Ankylos 3.5mm, 4.5mm, 5.5mm and 7.0mm Implants.
Please note: This device may be used in an early load situation, but is dependent on the specific implant system and protocol used by the dental professional.
Highly angled abutments on small diameter implants are intended for the anterior region of the mouth only.
The Atlantis Abutment and Atlantis™ Crown Abutment in Zirconia for Dentsply AnkylosImplant is compatible with the Dentsply Ankylos 3.5mm, 4.5mm, 5.5mm and 7.0mm Implants.
Please note: This device may be used in an early load situation, but is dependent on the specific implant system and protocol used by the dental professional.
Highly angulated abutments on small implants are to be used for the anterior region of the mouth only.
The devices covered in this submission are abutments which are placed into the dental implant to provide support for a prosthetic restoration. The subject abutments are for cemented, screw retained or friction fit restorations. The Atlantis™ Abutment and Atlantis™ Crown Abutment in Zirconia for Dentsply Ankylos 3.5mm, 4.5mm, 5.5mm and 7.0mm Implants is made of biocompatible material, yttria-stabilized tetragonal for the zirconia polycrystals (Y-TZP) ( meets ISO Standards 6972 & 13356). Zirconia may have variation in shade. The abutment screw is made of Titanium grade Ti-6A1-4V ELI (meets ASTM Standard F-136). The zirconia abutments are placed over the implant shoulder and are mounted into the implant with a titanium screw.
The provided document is a 510(k) summary for a medical device (dental abutments) and does not contain information related to AI/ML device acceptance criteria or studies as typically found in submissions for AI-powered diagnostics or medical image analysis.
The document describes the "Atlantis™ Abutment and Atlantis™ Crown Abutment in Zirconia for Dentsply Ankylos Implant" and its substantial equivalence to a predicate device. The "study" mentioned is non-clinical testing to demonstrate performance characteristics, not a clinical trial or AI/ML performance study.
Therefore, most of the requested information (acceptance criteria for AI, sample sizes for test/training sets, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, standalone performance) is not applicable to this type of device submission.
Here's a breakdown of the relevant information from the document:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't provide explicit "acceptance criteria" in the format of thresholds for metrics like sensitivity, specificity, or F1-score as you would see for an AI/ML device. Instead, the acceptance is based on demonstrating substantial equivalence to an already legally marketed predicate device (K#101004). The performance is demonstrated through non-clinical mechanical testing, ensuring the device can withstand intended forces.
| Acceptance Criterion (Implicit for Substantial Equivalence Determination) | Reported Device Performance |
|---|---|
| Material Composition Equivalence | Zirconia (Y-TZP) and Titanium (Ti-6A1-4V ELI) for new device; comparable to Titanium (Ti-6A-4V ELI) for predicate. Both meet relevant ISO/ASTM standards. |
| Performance Characteristics Equivalence | Allows prosthesis to be cemented/screw-retained; abutment screw secures abutment to implant. Similar to predicate. |
| Intended Use Equivalence | Same intended use: support prosthetic device, single/multiple tooth prosthesis in mandible/maxilla, compatible with Dentsply Ankylos implants. Similar to predicate. |
| Device Description & Clinical Use Equivalence | Compatible with Dentsply Ankylos implant sizes (3.5mm-7.0mm); may be used in early load situations; highly angulated abutments for anterior region. Similar to predicate. |
| Dimensions & Angulation Equivalence | Abutment sizes: 3.5mm, 4.5mm, 5.5mm, 7.0mm. Geometry limits: angles up to 30 degrees, widths up to 6.5mm, heights up to 15mm. Similar to predicate. |
| Mechanical Performance (Non-clinical Testing) | "Static and fatigue compression testing was conducted on 'worst case scenario' implant assemblies... Test results demonstrated that the Atlantis Abutments and Atlantis Crown Abutments are compatible with the Dentsply Ankylos Implant and the implant system supported appropriate static and fatigue test loads demonstrating that the implant system performs as intended." |
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated as a "test set" in the context of clinical or AI/ML performance evaluation. The "worst case scenario" implant assemblies used for static and fatigue testing would constitute the "test set" for the mechanical performance. The exact number of samples for these mechanical tests is not provided in this summary.
- Data Provenance: The mechanical testing would have been conducted in a laboratory setting, likely by the manufacturer or a contracted lab. Country of origin of the data is not specified but is presumed to be relevant to the manufacturer (Astra Tech Inc., Waltham, Massachusetts, USA). This is retrospective in the sense that the test results are reported after the tests were conducted prior to submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. Ground truth in the context of AI/ML evaluation (e.g., expert consensus on medical images) is not relevant for this mechanical device submission. The "ground truth" for mechanical testing is established by engineering standards and measurements.
4. Adjudication method for the test set:
- Not applicable. Adjudication methods like 2+1 or 3+1 are used for establishing ground truth from multiple human reviewers, which is not relevant here. Mechanical test results are typically objective measurements against predefined engineering specifications.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
- No. This is a mechanical device, not an AI/ML diagnostic.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No. This is a physical medical device, not an algorithm.
7. The type of ground truth used:
- For the mechanical performance component, the "ground truth" is derived from established engineering standards and material properties, along with the results of static and fatigue compression testing measured against performance specifications that demonstrate the device "performs as intended."
8. The sample size for the training set:
- Not applicable. There is no AI/ML component or "training set" in this submission.
9. How the ground truth for the training set was established:
- Not applicable.
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Kl20338
Premarket Notification Section 5: Page - 4
5 2012 JUL
510(k) Summary
Astra Tech Inc. Atlantis™ Abutment and Atlantis™ Crown Abutment in Zirconia for Dentsply Ankylos Implant
ADMINISTRATIVE INFORMATION
| 510K Summary preparation date: | July 5, 2012 |
|---|---|
| Manufacturer Name: | Astra Tech Inc. |
| 590 Lincoln Street | |
| Waltham, Massachusetts 02541 | |
| Telephone: 781-810-6462 | |
| Fax: 781-810-6719 | |
| Official Contact: | Frank Uyleman |
| Representative/Consultant: | Betsy A. Brown |
| B.A. Brown and Associates Inc. | |
| Telephone: 847-560-4406 | |
| Fax: 847-677-0177 |
DEVICE NAME AND CLASSIFICATION
| Trade/Proprietary Name: | AtlantisTM Abutment and AtlantisTM Crown Abutment inZirconia for Dentsply Ankylos Implant |
|---|---|
| Common Name: | Endosseous dental implant abutment21 CFR 872.3630 |
| Product Code: | NHA |
| Classification Panel: | Dental Products Panel |
| Reviewing Branch: | Dental Devices Branch |
INTENDED USE
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 prosthesis, 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.
This device is compatible with the following manufacturers' implant systems:
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The Atlantis Abutment in Zirconia for Dentsply Ankylos Implant is compatible with the Dentsply Ankylos 3.5mm, 4.5mm, 5.5mm and 7.0mm Implants.
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.
This device is compatible with the following manufacturers' implant systems: the Dentsply Ankylos 3.5mm, 4.5mm, 5.5mm and 7.0mm Implants.
Please note: This device may be used in an early load situation, but is dependent on the specific implant system and protocol used by the dental professional.
Highly angled abutments on small diameter implants are intended for the anterior region of the mouth only.
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 prosthesis, in the mandible or maxilla. The prosthesis can be cemented, screw retained or friction fit to the abutment screw is intended to secure the abutment to the endosseous implant.
{2}------------------------------------------------
Premarket Notification Section 5: Page - 5
DEVICE DESCRIPTION AND CLINICAL USE
The Atlantis Abutment and Atlantis™ Crown Abutment in Zirconia for Dentsply AnkylosImplant is compatible with the Dentsply Ankylos 3.5mm, 4.5mm, 5.5mm and 7.0mm Implants.
Please note: This device may be used in an early load situation, but is dependent on the specific implant system and protocol used by the dental professional.
Highly angulated abutments on small implants are to be used for the anterior region of the mouth only.
The devices covered in this submission are abutments which are placed into the dental implant to provide support for a prosthetic restoration. The subject abutments are for cemented, screw retained or friction fit restorations. The Atlantis™ Abutment and Atlantis™ Crown Abutment in Zirconia for Dentsply Ankylos 3.5mm, 4.5mm, 5.5mm and 7.0mm Implants is made of biocompatible material, yttria-stabilized tetragonal for the zirconia polycrystals (Y-TZP) ( meets ISO Standards 6972 & 13356). Zirconia may have variation in shade. The abutment screw is made of Titanium grade Ti-6A1-4V ELI (meets ASTM Standard F-136). The zirconia abutments are placed over the implant shoulder and are mounted into the implant with a titanium screw.
EQUIVALENCE TO MARKETED DEVICE
Astra Tech Inc. demonstrated that, for purposes of the FDA's regulations of medical devices, the Atlantis™ Abutment and Atlantis™ Crown Abutment in Zirconia for Dentsply Ankylos Implant is substantially equivalent in indication and design principles to the AtlantisTM Abutment for Dentsply Ankylos Implant cleared under K#101004 which has been determined by FDA to be substantially equivalent to preamendment devices.
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Premarket Notification Section 5: Page – 6
| TechnologicalCharacteristics | Atlantis™ Abutment andAtlantis™ CrownAbutment in Zirconia forDentsply Ankylos Implant | Atlantis™ Abutment forDentsply Ankylos ImplantK#101004 |
|---|---|---|
| MaterialComposition | -Biocompatible ceramicmaterial (abutment)- comparable compatibletitanium grade Ti-6A-4V ELImaterial (screw assembly) | -comparable compatible titaniumgrade Ti-6A-4V ELI material |
| Performancecharacteristics | Allows the prosthesis to becemented or screw retainedto abutment. While theabutment screw is intendedto secure the abutment to theendosseous implant. | Allows the prosthesis to becemented or screw retained toabutment. While the abutmentscrew is intended to secure theabutment to the endosseousimplant. |
| Intended Use | The Atlantis Abutment isintended for use with anendosseous implant tosupport a prosthetic device ina partially or completelyedentulous patient. It isintended for use to supportsingle and multiple toothprosthesis, in the mandible ormaxilla. The prosthesis canbe cemented, screw retainedor friction fit to the abutment.The abutment screw isintended to secure theabutment to the endosseousimplant.This device is compatiblewith the followingmanufacturers' implantsystems:The Atlantis Abutment inZirconia for DentsplyAnkylos Implant iscompatible with the DentsplyAnkylos 3.5mm, 4.5mm, | The Atlantis Abutment isintended for use with anendosseous implant to support aprosthetic device in a partially orcompletely edentulous patient. Itis intended for use to supportsingle and multiple toothprosthesis, in the mandible ormaxilla. The prosthesis can becemented, screw retained orfriction fit to the abutment. Theabutment screw is intended tosecure the abutment to theendosseous implant.The Atlantis™ Crown Abutmentin Zirconia is intended for usewith an endosseous implant tofunction as a substructure thatalso serves as the finalrestoration, in partially orcompletely edentulous patients.The prosthesis is screw retained. |
| Intended Use(continued) | 5.5mm and 7.0mm Implants.The Atlantis™ CrownAbutment in Zirconia isintended for use with anendosseous implant tofunction as a substructurethat also serves as the finalrestoration, in partially orcompletely edentulouspatients. The prosthesis isscrew retained. The abutmentscrew is intended to securethe crown abutment to theendosseous implant.This device is compatiblewith the followingmanufacturers' implantsystems:the Dentsply Ankylos3.5mm, 4.5mm, 5.5mm and7.0mm Implants.Please note: This device maybe used in an early loadsituation, but is dependent onthe specific implant systemand protocol used by thedental professional.Highly angled abutments onsmall diameter implants areintended for the anteriorregion of the mouth only. | The abutment screw is intendedto secure the crown abutment tothe endosseous implant. |
| Device Description andClinical Use | The Atlantis Abutment andAtlantis™ Crown Abutmentin Zirconia for DentsplyAnkylos | The Atlantis Abutment andAtlantis™ Crown Abutment inZirconia for Dentsply AnkylosImplant is compatible with the |
| Implant is compatible withthe Dentsply Ankylos3.5mm, 4.5mm, 5.5mm and7.0mm Implants.Please note: This device maybe used in an early loadsituation, but is dependent onthe specific implant systemand protocol used by thedental professional.Highly angulated abutmentson small implants are to beused for the anterior regionof the mouth only. Thedevices covered in thissubmission are abutmentswhich are placed into thedental implant to providesupport for a prostheticrestoration. The subjectabutments are for cemented,screw retained or friction fitrestorations. | Dentsply Ankylos 3.5mm,4.5mm, 5.5mm and 7.0mmImplants.Please note: This device may beused in an early load situation,but is dependent on the specificimplant system and protocol usedby the dental professional.Highly angulated abutments onsmall implants are to be used forthe anterior region of the mouthonly.The devices covered in thissubmission are abutments whichare placed into the dental implantto provide support for a prostheticrestoration. The subjectabutments are for cemented,screw retained or friction fitrestorations. | |
| Dimensions andAngulation | Abutment sizes: 3.5mm,4.5mm, 5.5mm and 7.0mmAtlantis Abutments designonly allows for geometrywithin the following limits:-Angles up to 30 degreesfrom the implant axis-Widths up to 6.5 mm fromthe implant axis-Heights (length) up to 15mm from the implantinterface | Implant sizes: 3.5mm, 4.5mm,5.5mm and 7.0mmAtlantis Abutments design onlyallows for geometry within thefollowing limits:-Angles up to 30 degrees from theimplant axis-Widths up to 6.5 mm from theimplant axis-Heights (length) up to 15 mmfrom the implant interface |
Table 1: Substantial Equivalence Summary
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Summary of Non-clinical Testing
Static and fatigue compression testing was conducted on "worst case scenario" implant assemblies using Atlantis angled zirconia abutments with the Dentsply Ankylos Implant. Test results demonstrated that the Atlantis Abutments and Atlantis Crown Abutments are compatible with the Dentsply Ankylos Implant and the implant system supported appropriate static and fatigue test loads demonstrating that the implant system performs as intended.
Conclusion for Substantial Equivalence:
The Atlantis™ Abutment and Atlantis™ Crown Abutment in Zirconia for Dentsply Ankylos Implant is substantially equivalent to the Atlantis™ Abutment for Dentsply Ankylos Implant K#101004 predicate device based on noted similarities in indication, manufacturing material, generated design principle and performance characteristics data.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/7/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" arranged around the perimeter. Inside the circle is an emblem featuring a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Astra Tech, Incorporated C/O Ms. Betsy Brown Regulatory Consultant B.A. Brown & Associates 8944 Tamaroa Terrace Skokie, Illinois 60076
5 2012 JUL
Re: K120338
Trade/Device Name: Atlantis™ Abutment and Atlantis™ Crown Abutment in Zirconia for Dentsply Ankylos Implant Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: June 9, 2012 Received: June 12, 2012
Dear Ms. Brown:
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.
{8}------------------------------------------------
Page 2 - Ms. Brown
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-related 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 go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely vours.
Anthony D. Awater
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{9}------------------------------------------------
Premarket Notification
Section 4: Page - 3
| 510(k) Number (if known) | K120338 |
|---|---|
| -------------------------- | --------- |
Indications for Use
| Device Name: | Atlantis™ Abutment and Atlantis™ Crown Abutment in Zirconia for Dentsply Ankylos Implant |
|---|---|
| -------------- | ------------------------------------------------------------------------------------------ |
Indication for Use:
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 prosthesis, 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.
This device is compatible with the following manufacturers' implant systems:
The Atlantis Abutment in Zirconia for Dentsply Ankylos Implant is compatible with the Dentsply Ankylos 3.5mm, 4.5mm, 5.5mm and 7.0mm Implants.
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.
This device is compatible with the following manufacturers' implant systems:
the Dentsply Ankylos 3.5mm, 4.5mm, 5.5mm and 7.0mm Implants.
Please note: This device may be used in an early load situation, but is dependent on the specific implant system and protocol used by the dental professional.
Highly angled abutments on small diameter implants are intended for the anterior region of the mouth only.
| Prescription Use | X |
|---|---|
| (Part 21 CFR 801 Subpart D) | AND/OR Over-the-Counter Use(21 CFR 801 Subpart C) |
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Anesthesiology, General Hospital
Infection Control, Dental Devices
i, Dol Infection
K 120 338 510(k) Number: __
510K Number:
§ 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.)