(160 days)
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.
This proposed Magellan™ Bone Level Abutment System is based upon the currently cleared Regular CrossFit® (RC) and Narrow CrossFit® (NC) screw-retained Bar and Bridge Abutment Line under premarket notification K080239. The Magellan product line includes one-piece straight abutments for the NC interface, straight and angled (17° and 30°) abutments for the RC interface, basal screws, occlusal screws, protective caps and titanium and gold restorative copings.
This submission, K133421 for the Straumann® Magellan™ Abutment System, is a Traditional 510(k) for a dental implant abutment. The review focuses on demonstrating substantial equivalence to predicate devices, rather than establishing clinical efficacy through direct performance testing with acceptance criteria in the typical sense of a diagnostic or therapeutic medical device.
Therefore, the "acceptance criteria" here are primarily based on equivalence to the predicate device's design, materials, and performance standards, specifically dynamic fatigue testing for dental implants.
1. Table of Acceptance Criteria and Reported Device Performance
| Feature/Test | Acceptance Criteria (based on predicate equivalence and ISO standard) | Reported Device Performance |
|---|---|---|
| Technological Characteristics | ||
| Implant/Abutment Connection | Equivalent to predicate device's CrossFit® connection. | CrossFit® connection with anti-rotation feature. Deemed Equivalent: "Anti-rotation feature not required for bar and bridge constructs." |
| Diameter | Diameters of subject devices to be within the range of the predicate devices (RC: Ø4.0, 4.5, 6.5 mm; NC: Ø3.5, 4.5 mm). | RC: Ø4.6 mm, NC: Ø3.5, 4.6 mm. Deemed Equivalent: "The diameters of the subject devices are within the range of the predicate devices." |
| Gingival Height (GH) | Gingival heights offered to be within the range of the predicate devices (1.0 mm, 2.5 mm, 4.0 mm). | 1.0mm, 2.5 mm, 4.0 mm. Deemed Equivalent: "The gingival heights of the subject devices are within the range of the predicate devices." |
| Abutment Height | Abutment heights offered to be within the range of the predicate devices (1.0 mm, 4.6 mm). | 1.7 mm, 1.9 mm. Deemed Equivalent: "The abutment heights of the subject devices are within the range of the predicate devices." |
| Materials | ||
| Titanium-Aluminum-Niobium Alloy (Ti-6AI-7Nb) | Meeting the requirements of ISO 5832-11. | Manufactured from Ti-6AI-7Nb, meeting ISO 5832-11 requirements. |
| Gold Copings | Made from Ceramicor® alloy. | Made from Ceramicor® alloy. |
| Protective Caps | Made from Polyether Ether Ketone (PEEK). | Produced from PEEK. |
| Performance Testing | ||
| Dynamic Fatigue Performance | Expected to meet the requirements of ISO 14801 (Dentistry - Implants - Dynamic fatigue test for endosseous dental implants for abutment connection performance). The acceptance criteria for this standard typically involve testing a statistically significant number of samples to a specified load and number of cycles (e.g., 5,000,000 cycles for fatigue strength) without failure, or demonstrating fatigue strength at a level comparable or superior to the predicate device. | Bench testing per ISO 14801 was performed to evaluate the dynamic fatigue performance of the subject devices. The submission indicates this testing supports the conclusion of substantial equivalence; implicitly, the device met the performance requirements of the standard, thereby being equivalent to or better than the predicate's expected performance, given the lack of specific numerical criteria provided in the summary. |
2. Sample Size Used for the Test Set and Data Provenance
The submission describes bench testing for performance evaluation.
- Sample Size: Not explicitly stated in the provided text for each specific test within ISO 14801. ISO standards typically mandate a minimum number of samples for statistical significance in mechanical testing (e.g., 5-6 samples for each test condition for fatigue testing to determine a fatigue limit).
- Data Provenance: Bench test data, therefore, no country of origin for patient data. It is inherently retrospective in the sense that the testing was completed prior to submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. This submission relates to a physical medical device (dental abutment) and its mechanical performance, not a diagnostic algorithm or image analysis requiring expert ground truth for interpretation. The "ground truth" for the performance criteria is defined by international engineering standards (ISO 14801).
4. Adjudication Method for the Test Set
Not applicable. There is no human interpretation or subjective assessment that would require adjudication for the bench test results. The results are objective measurements of mechanical properties.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve With AI vs Without AI Assistance
Not applicable. This is not an AI/software device and no human reader studies were conducted.
6. If a Standalone (i.e., algorithm-only without human-in-the-loop performance) Was Done
Not applicable. This is not an algorithm-based device.
7. The Type of Ground Truth Used
The "ground truth" for demonstrating device safety and effectiveness in this context is based on established engineering standards (ISO 14801) and equivalence to legally marketed predicate devices. The materials also conform to ISO 5832-11. There is no pathology, outcomes data, or expert consensus used for the "ground truth" in the way it's typically applied to diagnostic or prognostic devices.
8. The Sample Size for the Training Set
Not applicable. There is no "training set" as this is a physical medical device submission, not a machine learning or AI algorithm.
9. How the Ground Truth for the Training Set Was Established
Not applicable. There is no "training set" or need for ground truth establishment for a training set.
{0}------------------------------------------------
Traditional 510(k) Submission – Straumann® Magellan™ Abutment System
APR 1 7 2014
| 5. 510(k) Summary - K133421 | |
|---|---|
| SUBMITTER: | Straumann USA, LLC(on behalf of Institut Straumann AG)60 Minuteman RoadAndover, MA 01810 |
| CONTACT PERSON: | Charlotte RinglebRegulatory Affairs Associatecharlotte.ringleb@straumann.com978-.747.2552 |
| SUBMISSION DATE | November 5, 2013 |
| PRODUCT CODE | NHA (21 CFR §872.3630) |
| DEVICE CLASS | II (21 CFR §872.3630) |
| CLASSIFICATION PANEL | Dental |
| CLASSIFICATION NAME | Endosseous dental implant abutment (21 CFR §872.3630) |
| PROPRIETARY NAME | Straumann Magellan Screw-Retained Abutment System |
| PREDICATE DEVICES | (K990342) Straumann® synOcta screw-retained 1.5 mmAbutment Line(K080239) Straumann® RC/NC Bar and Bridge AbutmentLine(K072071) Straumann® Bone Level Cementable Screw(K101945) Neodent CM Exact Mini Angled Abutment |
| DEVICE DESCRIPTION | This proposed Magellan™ Bone Level Abutment System isbased upon the currently cleared Regular CrossFit® (RC)and Narrow CrossFit® (NC) screw-retained Bar and BridgeAbutment Line under premarket notification K080239.The Magellan product line includes one-piece straightabutments for the NC interface, straight and angled (17° and30°) abutments for the RC interface, basal screws, occlusalscrews, protective caps and titanium and gold restorativecopings. |
. .
{1}------------------------------------------------
INDICATIONS FOR USE
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.
TECHNOLOGICAL CHARACTERISTICS
The Straumann Magellan Screw-Retained Abutments, and associated subject devices are manufactured using precision machining systems from solid material (i.e. one-piece construction). Device features faciliate a precise fit with mating features of the previously cleared Straumann Bone Level implants.
| FEATURE | SUBJECT DEVICEMagellan Screw-Retained Abutments | PREDICATE DEVICEBar & Bridge Abutment(K080239) | EQUIVALENCEDISCUSSION |
|---|---|---|---|
| Implant/AbutmentConnection | CrossFit® connection withanti-rotation feature | CrossFit® connectionwithout anti-rotationfeature | EquivalentAnti-rotation feature notreqired for bar and bridgeconstructs |
| Diameter | The diameters are as notedfor Regular CrossFit (RC)and Narrow Crossfit (NC):RC: Ø4.6 mmNC: Ø3.5, 4.6 mm | The diameters are as notedfor Regular CrossFit (RC)and Narrow Crossfit (NC):RC: Ø4.0, 4.5, 6.5 mmNC: Ø3.5, 4.5 mm | EquivalentThe diameters of thesubject devices are withinthe range of the predicatedevices. |
| Gingival Height (GH) | The gingival heightsoffered follow:1.0mm2.5 mm4.0 mm | The gingival heightsoffered follow:1.0 mm2.5 mm4.0 mm | EquivalentThe gingival heights of thesubject devices are withinthe range of the predicatedevices. |
| Abutment Height | The height of theabutments are as noted:1.7 mm1.9 mm | The height of theabutments are as noted:1.0 mm4.6 mm | EquivalentThe abutment heights ofthe subject devices arewithin the range of thepredicate devices. |
MATERIALS
The Straumann Magellan Screw-Retained Abutments, basal screws and occlusal screws are manufactured from a titanium-aluminium-niobium alloy (Ti-6AI-7Nb or TAN) meeting the requirements of ISO 5832-11. The material for the gold copings is Ceramicor® alloy. The protective caps are produced from polyether ether ketone (PEEK).
{2}------------------------------------------------
PERFORMANCE TESTING
Performance testing of the subject devices was conducted per the FDA guidance Guidance for Industry and FDA Staff – Class II Special Controls Guidance Document: Root-form Endosseious Dental Implants and Endosseous Dental Abutments dated May 12, 2004. Bench testing per ISO 14801 was performed to evaluate the dynamic fatigue performance of the subject devices. No animal or human clinical data was provided in support of this submission.
CONCLUSION
The documentation submitted in this premarket notification demonstrates the subject devices and are substantially equivalent to the identified predicate devices.
{3}------------------------------------------------
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus symbol. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 17, 2014
Straumann USA, LLC Ms. Charlotte Ringleb Regulatory Affairs Specialist 60 Minuteman Road Andover, MA 01810
Re: K133421
Trade/Device Name: Straumann® Magellan™ Abutment System Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: March 14, 2014 Received: March 18, 2014
Dear Ms. Ringleb:
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 addition " . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
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 I least of devised that I Dr. o lessan that your device complies with other requirements of the Act that I Dr has Intactions and regulations administered by other Federal agencies. You must or any I cochar salates and registements, including, but not limited to: registration and listing (21
{4}------------------------------------------------
Page 2 - Ms. Ringleb
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 (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 Small Manufacturers, International and Consumer Assistance at its tollfree 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" (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/ReportalProblem/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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Erin Keith -S
Erin I. Keith, M.S. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{5}------------------------------------------------
4. Indications for Use
510(k) Number (if known): K | 33401
Straumann® Magellan™ Abutment System Device Name:
Indications for Use:
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.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (Part 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)
Sheena A: Green-S
2014.04.17 15:54:46 -04'00'
Straumann USA, LLC
4-4
§ 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.)